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PMFLIST List Archives2024-03-19T11:23:19ZPowered by L-Soft's LISTSERV email list software
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http://www.lsoft.com/images/listserv_64x64.pngTesting of lyophilized peptide DS per USP 61
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;760220c8.2401
Hi everyone,<br><br>I am having a difficult time trying to find the answer to a fairly basic question. This is my first time sending a question to this list so I appreciate any help! I have noticed that a lyophilized peptide drug substance product is being sent and stored at -20C to a CTO for microbial limits testing per USP chapter 61. I know USP 1117 clearly states that DS should NOT be frozen prior to microbiological testing but does this apply when it is in a lyophilized state? From my understanding the DS powder is reconstituted, filtered prior to [...]
2024-01-31T22:32:43+00:00Lia Jeffreyhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;760220c8.2401Thank you Microbiologics!
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;c6823f8e.2401
The PMFList would like to thank Microbiologics for their continued support<br>of the PMF discussion group in 2024.<br><br>Microbiologics specializes in producing lyophilized QC microorganisms for<br>use in the clinical, pharmaceutical, cosmetic, dietary supplement, food,<br>water, environmental and educational industries. Microbiologics’ mission is<br>"to provide the highest quality biomaterials for a safer, healthier world".<br><br>Without the support of corporate sponsors such as Microbiologics (and the<br>others listed at the bottom of each Email from the list) this service would<br>not be possible. The Pharmaceutical Microbiology Forum is truly grateful<br>for all of our sponsors over the past 20+ years.
2024-01-31T10:08:05-05:00David Porterhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;c6823f8e.2401Swiss medic requirement
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;1e2582be.2401
I have heard that swissmedic are requiring that all aseptic manufacturing of product be performed in isolators by 2027. Does anyone have a link to where that statement may be posted?<br>Thanks<br><br>David Jones PhD<br><br>This message and any attachments are intended solely for the named addressee and may contain information that is privileged, confidential, copyrighted, and exempt from disclosure under applicable law. If the reader of this message is not the intended recipient, you are hereby notified that any dissemination, distribution or copying of this communication is strictly prohibited. If you have received this message in error, please notify [...]
2024-01-30T22:07:12+00:00David Joneshttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;1e2582be.2401Re: Water Testing Once a month
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;551ad6a0.2401
Dear Tony,<br><br>You are correct that WFI is used in the manufacturing of Active<br>Pharmaceutical Ingredients (API’s) that are used in parenteral use<br>drugs or is intended for the manufacturing of ATMPs that are not<br>subject to a subsequent sterilization step (such as cell based<br>products). If you looked at the original post, the person said that<br>they were allowed to use potable water in the manufacturing of their<br>API. [...]
2024-01-30T12:32:19-05:00Donald Englishhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;551ad6a0.2401Re: New Recall of Solid Oral Dosages
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;7314b1eb.2401
The eleven recalled products are tablet product formulations. It says<br>that there was the presence of stagnant water in the duct of<br>manufacturing equipment. I’m wondering what type of manufacturing<br>equipment in which stagnant water had been found to be present because<br>tablet manufacturing can be somewhat complex in comparison to aqueous<br>product formulations.<br><br>For example, the first step of tablet manufacturing involves milling,<br>grinding, or crushing each of the ingredients to the same particle<br>size by using either a hammer, colloidal, roller, or a conical mill.<br>After milling, mixing or blending of tablet ingredients in the<br>formulation is performed [...]
2024-01-29T23:10:06-05:00Donald Englishhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;7314b1eb.2401Re: New Recall of Solid Oral Dosages
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;128e1cf4.2401
If the ducts were dirty it was probably mold. I’ve seen that many times and sometimes the remedy involved tearing apart the HVAC system and even entire clean rooms. Not a fun experience.<br><br>Sent from my iPhone<br><br>> On Jan 29, 2024, at 10:25 AM, Rick Jakober <rjakober@perrittlab.com> wrote:<br>><br>> An interesting comment in the recall notice was "Microbial contamination was reported<br>> in stagnant water in the duct of the manufacturing equipment.” This does not sound like a water system issue but rather an equipment cleaning issue, especially drying. And they obviously found microbial contamination that could have [...]
2024-01-29T18:21:42-05:00fsett1http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;128e1cf4.2401Re: New Recall of Solid Oral Dosages
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;60c44739.2401
An interesting comment in the recall notice was "Microbial contamination was reported<br>in stagnant water in the duct of the manufacturing equipment.” This does not sound like a water system issue but rather an equipment cleaning issue, especially drying. And they obviously found microbial contamination that could have potentially impacted all 11 of these finished solid oral dosage forms. I'd love to find out more about this! [...]
2024-01-29T14:23:33+00:00Rick Jakoberhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;60c44739.2401Re: New Recall of Solid Oral Dosages
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;fd9b0286.2401
Tony,<br><br>What you provided was a recall from 7 years ago. The full detail of the current recall is not yet public, although some news outlets have reported that it is a fungal (yeast) contamination.<br><br>Sincerely,<br><br>Marc Glogovsky, MS, S.M. (NRCM)<br>Business Unit Manager - Microbiology Consulting<br>609.432.1314<br><br>[Image]<br><br>valsource.com<http://valsource.com/core-services/>
2024-01-29T01:16:54+00:00Marc Glogovskyhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;fd9b0286.2401Re: Sterility method validation
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;943757c3.2401
Hi Nazli. I agree with Michael. We need to know much more about what you’ve tried to give you some feedback. Have you tried a non-binding membrane? Chemical neutralization? Dilution? Rinsing? Enzymatic neutralizing? Does your product have a long history of being anti microbial against that class of organisms? You’ll have to provide a lot of data to justify your decision.
2024-01-28T22:51:19+00:00Timothy Cserhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;943757c3.2401Re: Sterility method validation
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;421b043d.2401
As Michael and Tony indicate, there are multiple combinations between<br>chemical neutralizers, enzymes, dilution, filtration or the combination of<br>these, to find the specific method, which allows to inhibit the fungistatic<br>and / or bacteriostatic activity of the product under study.<br>Maybe you could share what the asset is, and we can help you. [...]
2024-01-28T19:50:10-03:00Daniela Sánchezhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;421b043d.2401Re: New Recall of Solid Oral Dosages
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;b11ab0b.2401
Rick,<br><br>These details are obtained from the FDA website. Not a good situation given<br>the patient population<br><br>Tony<br><br>On Sun, Jan 28, 2024 at 5:29 PM Rick Jakober <rjakober@perrittlab.com><br>wrote:<br><br>> Sun Pharma is recalling about 200,000 bottles from 11 different products<br>> due to “cGMP deviations. Microbial contamination was reported in stagnant<br>> water in the duct of the manufacturing equipment.”<br>> These are all non-sterile solid oral dosage forms. Does anyone know<br>> anything further about this?<br>><br>><br>> https://www.accessdata.fda.gov/scripts/ires/?Event=93820<br>><br>> Rick Jakober<br>> VP Laboratory Services<br>> Perritt Laboratories, Inc<br>> www.perritt.com<br>><br>> Sent from [...]
2024-01-28T17:46:28-05:00Tony Cundellhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;b11ab0b.2401New Recall of Solid Oral Dosages
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;444e5b4b.2401
Sun Pharma is recalling about 200,000 bottles from 11 different products due to “cGMP deviations. Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.”<br>These are all non-sterile solid oral dosage forms. Does anyone know anything further about this?<br><br>https://www.accessdata.fda.gov/scripts/ires/?Event=93820<br><br>Rick Jakober<br>VP Laboratory Services<br>Perritt Laboratories, Inc<br>www.perritt.com<br><br>Sent from my iPhone
2024-01-28T21:41:42+00:00Rick Jakoberhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;444e5b4b.2401Re: Sterility method validation
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;52e65ab7.2401
Nazli,<br><br>Antibiotics must be removed from the test material by filtration, dilution,<br>enzymatic degradation or chemical neutralization to pass the method<br>suitability test.<br>However, if the antibiotic is highly active against one of the challenge<br>organisms you can assume that this organism will not survive in the product<br>and you can forgo method suitability testing with that organism. [...]
2024-01-28T15:58:11-05:00Tony Cundellhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;52e65ab7.2401Re: Sterility method validation
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;713e9b94.2401
Hi,<br><br>If you have tried different methods and the product have inhibiting nature,<br>you can conclude the same in the report and continue routine testing,<br>release.<br>Pharmacopoeia allows this.<br><br>Best Regards,<br><br>Vijay Kishore.<br><br>On Sun, 28 Jan 2024 at 18:41, Nazlı TEKİN <nazli.tekin@nobel.com.tr> wrote:<br><br>> Hello All,<br>> If i can not get any recovery for some microorganism on the sterility<br>> method validation, can i report that it can not get recovery for x<br>> microorganism and this product is effective for x microorganism?<br>> Or should i repeat the test as long as getting recovery by the different<br> [...]
2024-01-28T19:54:46+04:00Vijay Kishore Shttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;713e9b94.2401Re: Sterility method validation
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;6580644a.2401
No. You must pass method suitability for a compendial sterility test. What procedure did you use and what other methods have you tried to overcome the antimicrobial activity in the tested product?<br><br>Michael<br><br>Michael J. Miller, Ph.D.<br>President<br>Microbiology Consultants, LLC<br>19009 St. Laurent Drive, Lutz, FL 33558<br>phone: 727-437-2743 (RAPID-RAPID)<br>email: mjm@microbiologyconsultants.com <applewebdata://37B460F2-ED36-4F29-8974-F336F9F98DBC/mjm@microbiologyconsultants.com><br>web: http://microbiologyconsultants.com <http://microbiologyconsultants.com/><br>linkedIn: http://www.linkedin.com/in/drmichaelmiller <http://www.linkedin.com/in/drmichaelmiller> [...]
2024-01-28T10:48:31-05:00Dr. Michael J. Millerhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;6580644a.2401Thank you, Veltek Associates Inc.
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;ff8ed84d.2401
The PMFList would like to thank Veltek Associates Inc. for their continued<br>support of the PMF discussion group in 2024.<br><br>Veltek Associates, Inc. designs innovative solutions to address the control<br>of particulate and microbial contamination in pharmaceutical and<br>biotechnology operations worldwide. VAI strives to develop meaningful<br>technical relationships with their clients to ensure that VAI products<br>meet, if not exceed, their unique requirements. [...]
2024-01-28T10:09:10-05:00David Porterhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;ff8ed84d.2401new content posted to PMF website
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;14daf6bb.2401
David Porter <dapperdavid59@gmail.com><br>Wed, Jan 24, 2:14 PM (4 days ago)<br>to The<br>New content posted at the PMF website:<br><br>FDA Regulatory Actions update ("January 24, 2024", goes back to November<br>2023) can be found at:<br><br>http://www.microbiologyforum.org/content/file/Regulatory%20Actions/RA%20January%2026%202024.pdf<br><br>Please consider sponsoring the PMF. Sponsorship dollars go to supporting<br>website developments and a token remuneration to PMF staff. Information may<br>be found at http://www.microbiologyforum.org/sponsors.asp under<br>"Sponsorship Packages". [...]
2024-01-28T09:54:03-05:00David Porterhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;14daf6bb.2401Sterility method validation
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;609dbf9c.2401
Hello All,<br>If i can not get any recovery for some microorganism on the sterility method validation, can i report that it can not get recovery for x microorganism and this product is effective for x microorganism?<br>Or should i repeat the test as long as getting recovery by the different methods?<br>Note: This product has antimicrobial activity. [...]
2024-01-28T10:47:08+00:00Nazlı TEKİNhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;609dbf9c.2401Re: Water Testing Once a month
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;441e13c5.2401
Don,<br>Low-endotoxin water or WFI are used for the manufacture of API for sterile<br>drug products.<br><br>Periodic heat sterilization is commonly used for microbial control of PW<br>distribution systems.<br>Tony<br><br>On Tue, Jan 23, 2024 at 10:24 PM Donald English <<br>donaldgale.english@gmail.com> wrote:<br><br>> Dear Tony,<br>><br>> I do not think that it would be common to use a WFI system to provide<br>> water that is used in the manufacturing process of an API. I do<br>> totally agree that WFI systems should be used in the manufacturing of<br>> sterile water based injections.<br>><br>> If I was [...]
2024-01-23T22:38:26-05:00Tony Cundellhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;441e13c5.2401Re: Water Testing Once a month
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;51399c60.2401
Dear Tony,<br><br>I do not think that it would be common to use a WFI system to provide<br>water that is used in the manufacturing process of an API. I do<br>totally agree that WFI systems should be used in the manufacturing of<br>sterile water based injections.<br><br>If I was an accountant for the API manufacturer, I do not think that I<br>could justify the cost in having a WFI system for the manufacturing of<br>an API. Besides, ICH Q7 states that portable water can be used to<br>make their API. If you want to use water from a purified [...]
2024-01-23T17:07:24-05:00Donald Englishhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;51399c60.2401Re: Water Testing Once a month
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;b3fdffe3.2401
<< I understand that the risk is that more batches would be affected if there was contamination in the water system, but I can't think of any other risks involved. >><br><br>I always thought that “batches effected with microbial contamination” was more than a sufficient reason alone to err on the safe side here. [...]
2024-01-23T13:53:37-05:00Joel Russohttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;b3fdffe3.2401Re: Water Testing Once a month
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;4dcb1c71.2401
Don,<br>It would be unusual to maintain a PW tank and loop at 80 degree C. The hot<br>water in a WFI system is usually derived from the distillation process.<br><br>After PW system validation and a testing history I would be comfortable<br>based on direct experience in testing an ozone-treated PW system monthly.<br><br>Tony<br><br>On Mon, Jan 22, 2024 at 8:39 PM Donald English <donaldgale.english@gmail.com><br>wrote: [...]
2024-01-23T10:44:13-05:00Tony Cundellhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;4dcb1c71.2401Re: USP water
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;38f65a6f.2401
Dear Deborah,<br><br>Anthony is 100% correct that you cannot compare conductivity and TOC<br>readings between samples that are taken on-line to those analyzed<br>offline. Generally, ambient air contains 300 to 500 ppm of Carbon<br>dioxide. When an offline purified water sample comes into contact<br>with air, carbon dioxide dissolves in the water causing the<br>conductivity to rise by about 1 µS/cm. In addition, you have the<br>problem of the sample collection containers and the time between<br>collection and testing besides the absorption of Carbon dioxide from<br>air. Storage of water in glass containers for several hours is<br>usually good, but [...]
2024-01-22T20:21:15-05:00Donald Englishhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;38f65a6f.2401Re: Water Testing Once a month
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;937bb77f.2401
Dear Jessica,<br><br>If you have a hot purified water circulating distribution loop in<br>which the water temperature is at 80 C, I think that it would be a low<br>risk in having microbial contamination issues at a use-point. I do not<br>think that it would be an issue if monthly testing is conducted since<br>the risk of having a microbial contamination issue is very low. [...]
2024-01-22T19:13:42-05:00Donald Englishhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;937bb77f.2401Re: USP water
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;2cc4c78.2401
Deborah,<br><br>Interesting question.<br><br>In my experience TOC and lab analysis typically have higher but passing<br>results which is probably a sampling and testing artifact. Does this mean<br>they are not equivalent?<br><br>In terms of fitness for purpose, continuous online monitoring is superior<br>to grab sampling and lab testing in terms of control and cost<br><br>Tony<br><br>On Mon, Jan 22, 2024 at 10:03 AM Deborah Edwards <<br>0000004967037e4c-dmarc-request@lists.microbiologynetwork.com> wrote: [...]
2024-01-22T11:29:14-05:00Tony Cundellhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;2cc4c78.2401Re: USP water
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;2ed21753.2401
Deborah,<br><br>Full disclosure - I am employed by mfgr of TOC and conductivity instruments.<br><br>Be wary of the question - are you asking about the equivalency of the water (comparing samples in-line or at-line to samples in the lab), or are you asking about equivalency about the instruments? The reason to ask is that the conductivity will be higher for any sample exposed to air (that is why testing limit at Stage 2 (25C) in USP <645> is higher than the Stage 1 in-line limit). Also, in <643> Total Organic Carbon, caution is noted for taking offline samples because of [...]
2024-01-22T16:26:49+00:00Bevilacqua Anthony THORNTONhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;2ed21753.2401Re: USP water
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;31e5291a.2401
Good morning .<br>It is better to test in line but you must take into account that your<br>system is suitable to approve in stage 1 almost 100% of the days. Another<br>advantage is that you can monitor regularly over 24 hs. The test in QC only<br>reflects the quality of water in a moment.<br>Best regards.<br>Espiral de Calidad<br>Director [...]
2024-01-22T12:52:27-03:00Néstor Oscar Aversahttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;31e5291a.2401USP water
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;826e3016.2401
Hello, I have a question about USP water...<br><br>If USP water is currently tested for TOC and conductivity using benchtop equipment, is equivalency testing required if we want to move to an inline monitoring system for TOC and conductivity?<br><br>Regards,<br>Deborah Edwards<br>Senior Scientist<br>Microbiology<br><br>Haleon<br>Haleon.com<br>deborah.e.edwards@haleon.com<mailto:deborah.e.edwards@haleon.com><br>804-257-2914<br><br>The Earth is a fine place and worth fighting for. - Ernest Hemingway<br>[Icon Description automatically generated] [...]
2024-01-22T12:55:27+00:00Deborah Edwardshttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;826e3016.2401Re: Water Testing Once a month
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;8c1d610d.2401
In terms of risk management, once per month may be tooin frequent. You<br>could test the storage tank and return loop and any POU for product<br>ingredient water at a higher frequency.<br><br>On Thu, Jan 18, 2024 at 10:30 AM Dayanand Mukane <dayanandmukane@gmail.com><br>wrote:<br><br>> Hello Jessica,<br>><br>> As per USP you can test representing point i.e. return loop at regular<br>> basis and rest all points of loop at once in month frequency ensuring that<br>> weekly sampling of points somewhere from loop.<br>><br>> Regards<br>> Dayanand Mukane<br>><br>> On Thu, 18 Jan, 2024, 1:55 am Jessica, [...]
2024-01-18T11:03:03-05:00Tony Cundellhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;8c1d610d.2401Re: Water Testing Once a month
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;5cecef28.2401
Hello Jessica,<br><br>As per USP you can test representing point i.e. return loop at regular<br>basis and rest all points of loop at once in month frequency ensuring that<br>weekly sampling of points somewhere from loop.<br><br>Regards<br>Dayanand Mukane<br><br>On Thu, 18 Jan, 2024, 1:55 am Jessica, <jmicro73@gmail.com> wrote:<br><br>> Hello,<br>><br>> We manufacture APIs that are low risk for microbial contamination.<br>><br>> ICH Q7 states that we can use portable water for manufacturing our<br>> products. We use High Purity water which is always <0.01 CFU/mL. Never had<br>> any contamination in the water system. We currently [...]
2024-01-18T07:24:03+05:30Dayanand Mukanehttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;5cecef28.2401Re: Water Testing Once a month
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;e9f96c99.2401
Water used for API manufacturing must be suitable for its intended use (ICH Q7). That being said, you need to provide additional information.<br><br>First, provide a justification that your API is a low risk for contamination. During manufacturing? During storage? Physical state of the API?<br><br>How do you currently test your water? Sample size? Media and incubation parameters? Where are the samples coming from? How do you maintain the water system? [...]
2024-01-17T16:21:57-05:00mjm@microbiologyconsultants.comhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;e9f96c99.2401Re: Water Testing Once a month
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;e6b2bbc0.2401
Hi Jessica. USP 1231 states "Water systems should be monitored at a frequency that is sufficient to ensure that the system is in control and continues to produce water of acceptable quality."<br><br>If you have a long history of no Alerts or Action levels and feel like you can reduce your sampling based on those risk assumptions along with product/operations risk assessments, I don't see a problem with it being that you're already holding yourself to a higher water purity standard. That being said, in general, authorities don't like seeing reduction in testing without justification, so I'd be sure to [...]
2024-01-17T20:50:57+00:00Timothy Cserhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;e6b2bbc0.2401Water Testing Once a month
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;8f0e3f46.2401
Hello,<br><br>We manufacture APIs that are low risk for microbial contamination.<br><br>ICH Q7 states that we can use portable water for manufacturing our<br>products. We use High Purity water which is always <0.01 CFU/mL. Never had<br>any contamination in the water system. We currently test the water weekly.<br>We would like to test only once a month. [...]
2024-01-17T13:55:54-05:00Jessicahttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;8f0e3f46.2401Re: Bili-tolerant gram negative bacteria OOS
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;c5ba5ec0.2401
Enterobacter cloacae is not a typical waterborne bacterium as it likes a<br>higher nutrient level that is found in purified water. Pumps, lines,<br>valves, septums,etc are more difficult to clean and if stored wet will<br>encourage biofilm formation. If the content of the mixer was used for<br>compressed tablets and not a dry powder inhalant the vegetative bacteria<br>would not survive the compression process. Do you use a nylon bristle brush<br>for a manual cleaning process? [...]
2024-01-17T12:07:50-05:00Tony Cundellhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;c5ba5ec0.2401Re: Bili-tolerant gram negative bacteria OOS
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;f83700f0.2401
I second what Michael mentioned and I would also add what a good friend of mine (Andy Dick) always notes when looking at equipment: Watch the mechanics actually dismantle ALL the equipment and especially look at the gaskets (that are typically ignored). Swab any discolored locations and you might find that the equipment is not as clean as it was supposed to be. [...]
2024-01-17T15:50:43+00:00Rick Jakoberhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;f83700f0.2401Re: Bili-tolerant gram negative bacteria OOS
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;4c589e4d.2401
We have found contamination in blending and related unit operations. Focus on remediation and prevention of wet surfaces. Also look at whether product residuals are hygroscopic that would allow moisture to form and allow microbial growth.<br><br>Michael (mjm@microbiologyconsultants.com)<br><br>> On Jan 17, 2024, at 1:22 AM, Irene Guillén <ireguillent@gmail.com> wrote:<br>><br>> Dear all,<br>><br>> We were thinking that biofilm is located in equipment where we performed<br>> blending. This is because the microorganism has been recovered only in 2<br>> rooms of the facilities.<br>> The analysis of PW has been performed with 100 ml in R2A, and we [...]
2024-01-17T08:23:18-05:00mjm@microbiologyconsultants.comhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;4c589e4d.2401Re: Bili-tolerant gram negative bacteria OOS
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;ec538454.2401
Irene:<br>You are testing 100 mL, while I am sure that your equipment sees a lot more water than that. Your levels could be much lower, but if the cleaned equipment is stored with any water left behind then the organisms will have a chance to proliferate and come to haunt you. I have seen this several times over the years. In addition, look at your equipment to make sure that water isn't getting where it doesn't belong. For example, I have seen water behind blender parts when a seal failed and the site ended up with a foul soup [...]
2024-01-17T11:15:41+00:00Knutsen, Chrishttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;ec538454.2401Re: Bili-tolerant gram negative bacteria OOS
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;4b2916b9.2401
Dear all,<br><br>We were thinking that biofilm is located in equipment where we performed<br>blending. This is because the microorganism has been recovered only in 2<br>rooms of the facilities.<br>The analysis of PW has been performed with 100 ml in R2A, and we have tried<br>VRBG, McConkey agar and CCA media, but the results were no growth. Plates<br>were incubated at 30-35°C.<br>Well water feeds the purified water system, and although we found<br>enterobacter in well water, it is not recovered at any of the PW loop point<br>of use. [...]
2024-01-17T06:30:53+01:00Irene Guillénhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;4b2916b9.2401Re: Bili-tolerant gram negative bacteria OOS
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;2fc20fbb.2401
What is the test method used for your water testing? Please provide the media, the sample size and the incubation parameters.<br>Michael<br><br>>> On Tue, 16 Jan 2024, 10:54 Irene Guillén, <ireguillent@gmail.com> wrote:<br>>><br>>> Thank you for your answer!!<br>>><br>>> The equipment cleaning is performed with purified water that comes from<br>>> well water with potable requirements. We analyse each point of use in PW<br>>> loop and we are not able to recover the microorganism.<br>>> In the product we found 2 species: one from enterobacter cloacae complex<br>>> and the other one is klebsiella oxytoca.<br>>> [...]
2024-01-16T17:54:21-05:00mjm@microbiologyconsultants.comhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;2fc20fbb.2401Re: Bili-tolerant gram negative bacteria OOS
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;f3ce67dd.2401
You need to investigate all aspects of the water system to determine where the bacteria are hiding. They could be in the piping (biofilms) or in filters or resins or carbon beds or points of use. Essentially the water system needs to be figuratively dismantled to find the little buggers. <br>Sincerely, [...]
2024-01-16T18:47:58+00:00Frank Settinerihttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;f3ce67dd.2401Re: Bili-tolerant gram negative bacteria OOS
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;c0404aa8.2401
Irene:<br>We had the same issue of identifying microbial growth from PW sample and the cause was found to be dispensing hose since swab sample recovered the same organism. As CA, we have a frequency of replacing the hose used in non-sterile solid dosage. For Liquid dosages, we autoclave every week and hang to ensure no stagnant water is retained. [...]
2024-01-16T10:29:12+00:00Vishwas Kelkarhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;c0404aa8.2401Re: Bili-tolerant gram negative bacteria OOS
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;c292dc28.2401
Hi Irene<br>Could I ask,<br>Why and from where exactly the swabs were collected from? Was it an<br>investigative swab on product contact equipment surface,without cleaning<br>post production(I guess not from the same batch) or an EM sample. What was<br>the disinfection done for ?<br><br>Thanks<br>Akhilesh<br><br>On Tue, 16 Jan 2024, 10:54 Irene Guillén, <ireguillent@gmail.com> wrote:<br><br>> Thank you for your answer!!<br>><br>> The equipment cleaning is performed with purified water that comes from<br>> well water with potable requirements. We analyse each point of use in PW<br>> loop and we are not able to recover the [...]
2024-01-16T17:44:48+08:00Akhilesh LAhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;c292dc28.2401Re: Bili-tolerant gram negative bacteria OOS
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;7905f482.2401
Thank you for your answer!!<br><br>The equipment cleaning is performed with purified water that comes from<br>well water with potable requirements. We analyse each point of use in PW<br>loop and we are not able to recover the microorganism.<br>In the product we found 2 species: one from enterobacter cloacae complex<br>and the other one is klebsiella oxytoca.<br>I was thinking about biofilm, but if I am not able to recover the<br>microorganism in purified water I focus on the facilities.<br>The raw materials were analysed for enterobacteria and the result was no<br>growth. It is a powder product in [...]
2024-01-15T21:42:12+01:00Irene Guillénhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;7905f482.2401Re: Bili-tolerant gram negative bacteria OOS
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;52b79d61.2401
Irene,<br><br>How are you using the well water for process equipment cleaning? Does it<br>meet potable water standards? Potable water is often used in CIP systems<br>and/or the initial rinse during the cleaning process with the final rinse<br>for a non-sterile drug product being purified water, USP.<br><br>Am I right based on the USP <1111> requirements that your product is for<br>inhalation use? If it is a liquid for nebulization it would be classified<br>as a sterile product [...]
2024-01-15T11:29:45-05:00Tony Cundellhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;52b79d61.2401Re: Bili-tolerant gram negative bacteria OOS
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;1078f82c.2401
Dear Irene,<br><br>What is the organism that you had isolated from the product?<br>Klebsiella oxytoca is not a member of Enterobacter cloacae complex. I<br>believe that Enterobacter cloacae complex (ECC) consists of the<br>following seven species: Enterobacter asburiae, Enterobacter cloacae,<br>Enterobacter hormaechei, Enterobacter kobei, Enterobacter lidwigii,<br>Enterobacter mori and Enterobacter nimimpressuralis.<br><br>I’m assuming that you are using a quaternary ammonium disinfectant<br>because they are prepared by the alkylation of a tertiary amine.<br>Gram-negative bacteria are generally less susceptible to the<br>antimicrobial activity of quaternary ammonium disinfectants due to<br>their outer membrane that makes it difficult for quats to reach the<br> [...]
2024-01-15T10:45:50-05:00Donald Englishhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;1078f82c.2401Bili-tolerant gram negative bacteria OOS
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;b7ac1a0c.2401
Dear microbiologists!<br><br>I need your opinión and guidance about a worried subject. I am performing<br>an OOS research for bili-tolerant gram negative bacteria. A product was<br>contaminated but we are not able to find the source of the microorganism.<br>We have performed the analysis in an external lab in order to confirm the<br>result and rule out any possible internal contamination in our lab.<br>The microorganism belongs to enterobacter cloacae complex and klebsiella<br>oxytoca. We have found the microorganism enterobacter in some surfaces<br>taken samples with swab. However, we have performed some disinfection<br>processes (with enzymatic and terciary amonium disinfectant) [...]
2024-01-15T06:47:03+01:00Irene Guillénhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;b7ac1a0c.2401Re: Pre incubation requirements for selective medias
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;87ddf4d3.2401
It is industry practice to incubate a small portion of an incoming lot of<br>media for confirm sterility. You could argue this is less important for<br>selective media. Typically you bring the plates to room temperature,<br>inspect the plates for appearance and contamination prior to use.<br><br>Media manufacturers typically store media at room temperature, conduct<br>growth promotion tests, annd conduct a 100% inspection prior to shipment. [...]
2024-01-14T10:11:39-05:00Tony Cundellhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;87ddf4d3.2401Pre incubation requirements for selective medias
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;d72a136a.2401
Dear PMF forum members,<br><br>Whether preincubation is required for Selective media or not as per<br>regulatory requirements?<br><br>Thanks & Regards,<br>Dr Nilesh<br>9820919185
2024-01-13T23:30:32+05:30Nilesh Shahhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;d72a136a.2401New Content Notice
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;d963632c.2401
Happy New Year to all of the PMFList subscribers!<br><br>You can expect some substantial changes to the PMF website this year (<br>www.microbiologyforum.org), including changes that will provide further<br>advantages to sponsors of the PMF and the PMFList. One of the changes is<br>indicated in this posting, based upon some feedback kindly sent in by<br>subscribers. The Weekly Bulletins are hereby replaced with postings<br>indicating only New Content added to the website. The idea here is to cut<br>to the chase, so to speak, for what new materials are available at the<br>website. Links to the new content will be [...]
2024-01-12T11:14:27-05:00David Porterhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;d963632c.2401Re: Changes to ATCC 9027 P. paraeruginosa
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;92e18255.2401
PFA...<br><br>On Wed, 10 Jan, 2024, 22:04 Shweta Bajoria, <shwetabaj@gmail.com> wrote:<br><br>> I had communicated about that as we have ordered ATCC9027 for p. aeruginosa<br>> We have received p. paraaeruginosa.<br>> There is a confirmation for the same on ATCC site.<br>><br>> They told that usp is in updation process. It will update p. aeruginosa as<br>> p. paraaeruginosa. May be this year or next.<br>><br>> On Mon, 8 Jan, 2024, 02:04 GP GP, <gdrbabu@gmail.com> wrote:<br>><br>> > Dear Team,<br>> ><br>> > USP FAQ for easy reference ,<br>> ><br>> > 1. Can [...]
2024-01-11T20:16:14+05:30Dinesh Prajapathttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;92e18255.2401Re: Changes to ATCC 9027 P. paraeruginosa
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;474af839.2401
I had communicated about that as we have ordered ATCC9027 for p. aeruginosa<br>We have received p. paraaeruginosa.<br>There is a confirmation for the same on ATCC site.<br><br>They told that usp is in updation process. It will update p. aeruginosa as<br>p. paraaeruginosa. May be this year or next.<br><br>On Mon, 8 Jan, 2024, 02:04 GP GP, <gdrbabu@gmail.com> wrote: [...]
2024-01-10T21:44:00+05:30Shweta Bajoriahttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;474af839.2401Re: EXTERNAL - [PMFLIST] feedback request, part 2
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;965f1e36.2401
Hello everyone,<br><br>I hope your doing well<br><br>For my side, the compendia updates, FDA regulatory actions, articles,<br>sponsor's corner and expertise from experts are the most useful.<br><br>I have an opinion, if possible you can organize webinar at least once per<br>month based on specialized areas.<br><br>Kind regards<br><br>Rashid Kihwelo<br>Assistant Manager - Microbiology<br>Shelys Pharmaceutical Ltd.<br><br>On Tue, Jan 9, 2024, 12:59 AM Bevilacqua Anthony THORNTON <<br>Anthony.Bevilacqua@mt.com> wrote: [...]
2024-01-09T10:36:50+03:00Rashid Kihwelohttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;965f1e36.2401time machine
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;8f203e1b.2401
Hi all:<br><br>So according to the first line of my second feedback request, it is 2924<br>("Happy 2924 to all participants of the PMFList!"). I knew there was a good<br>reason for me to quit poking fun at people making typos in comments<br>sections!<br><br>Cheers!<br><br>Dave
2024-01-08T17:04:16-05:00David Porterhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;8f203e1b.2401Re: EXTERNAL - [PMFLIST] feedback request, part 2
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;c7ae1c4f.2401
Dave,<br><br>Like many other persons, thank you for your leadership.<br><br>I had not answerer before, but my preferences for most valuable information are:<br><br>1. FDA actions<br>2. Articles/white paper<br>3. Compendial updates separated into 2 pieces: (this is a little new)<br>* Compendial changes that have been approved for future implementation<br>* Proposes changes (in PF or EU equivalent) that require comment [...]
2024-01-08T21:17:29+00:00Bevilacqua Anthony THORNTONhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;c7ae1c4f.2401Re: feedback request, part 2
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;7c152092.2401
Hi David<br><br>Thank you for all you do with the PMF List.<br><br>I find the FDA Regulatory Actions, Updates to Compendia, and Articles/White Papers sections the most useful.<br><br>I like your thoughts on a section related to Specific Topics. Making this section easily searchable would be helpful.<br><br>Thanks<br>Scott<br><br>-----Original Message-----<br>From: The Pharmaceutical Microbiology Forum Email List <PMFLIST@lists.microbiologynetwork.com> On Behalf Of David Porter<br>Sent: Monday, January 8, 2024 11:29 AM<br>To: PMFLIST@LISTS.MICROBIOLOGYNETWORK.COM<br>Subject: [PMFLIST] feedback request, part 2 [...]
2024-01-08T19:48:34+00:00Post, Scotthttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;7c152092.2401Re: feedback request, part 2
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;63818940.2401
The following is helpful (for me):<br><br>FDA Regulatory Actions YES<br>Updates to Compendia YES<br>Articles/White Papers NO<br>YouTube videos NO<br>Weekly Bulletins YES<br>E-books/Training NO<br>Reviews NO<br><br>Thank you,<br><br>Melinda Pence<br><br>-----Original Message-----<br>From: The Pharmaceutical Microbiology Forum Email List <PMFLIST@lists.microbiologynetwork.com> On Behalf Of David Porter<br>Sent: Monday, January 8, 2024 11:29 AM<br>To: PMFLIST@LISTS.MICROBIOLOGYNETWORK.COM<br>Subject: [PMFLIST] feedback request, part 2<br><br>Happy 2924 to all participants of the PMFList! [...]
2024-01-08T19:23:55+00:00melinda.pence@lonza.comhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;63818940.2401Re: feedback request, part 2
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;74bb99e7.2401
Dave,<br>For me, the only current section that I have never used is the videos.<br>For the new items, I think the topic corners would be useful, and sponsor corner could be as well.<br><br>Thanks for all you do,<br>Dale<br><br> <br>Dale Kelley, CQA (he/him)<br>QA Auditor Sr<br>Quality<br>Medline Industries, LP<br>dkelley@medline.com<br><br>-----Original Message-----<br>From: The Pharmaceutical Microbiology Forum Email List <PMFLIST@lists.microbiologynetwork.com> On Behalf Of David Porter<br>Sent: Monday, January 8, 2024 10:29 AM<br>To: PMFLIST@LISTS.MICROBIOLOGYNETWORK.COM<br>Subject: [PMFLIST] feedback request, part 2 [...]
2024-01-08T19:11:49+00:00Kelley, Dalehttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;74bb99e7.2401Re: feedback request, part 2
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;e6a38d3d.2401
Dave<br><br>I really like the *Specific topic area "Corners" for a new section. I save a lot of the emails for future reference and this might save some space for me on my computer, plus better organize them for me!!<br><br>Thanks much!<br><br>Shannon Wills<br>MicroPharm LLC<br>QC Microbiology, Quality Systems Consulting<br>Cedar Park, TX<br>Cell: (512) 567-5764 [...]
2024-01-08T19:10:07+00:00Shannon Willshttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;e6a38d3d.2401Re: feedback request, part 2
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;5ffc953b.2401
Hi Dave,<br><br>I appreciate your 'manning' the PMF site!<br><br>Like others have expressed, the most useful items to me are<br>the FDA Regulatory Actions<br>Updates to Compendia, and<br>Articles/White Papers<br><br>As a consultant, if my work requires a focus in a specific area - I would<br>certainly look through the PMF list resources to see if there was some<br>information that I could use - egs. Training. [...]
2024-01-08T11:51:38-05:00Brien Davidhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;5ffc953b.2401feedback request, part 2
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;1e0d8704.2401
Happy 2924 to all participants of the PMFList!<br><br>I want to thank you all for your participation in the PMFList in 2023, and<br>I look forward to much more in 2024. This posting is a partial repeat of<br>one sent earlier soliciting feedback in a number of areas. I thank all of<br>you who have submitted feedback, and I would like to encourage you to send<br>feedback if you have not done so yet. Your feedback will help improve the<br>PMF website, and the forum, as well, making them both more useful for you. [...]
2024-01-08T11:29:28-05:00David Porterhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;1e0d8704.2401Re: Changes to ATCC 9027 P. paraeruginosa
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;d367ec04.2401
Dear Team,<br><br>USP FAQ for easy reference ,<br><br>1. Can I use strains other than those that are cited in the USP?<br><br>You should use the strains that are cited in General Chapter <61> or<br>equivalent strains from other culture collections. For example, if<br>Pseudomonas aeruginosa ATCC 9027 is indicated, you should use this strain<br>or strains from other culture collections claiming equivalence to ATCC<br>9027. Other strains such as ATCC 14149 are not appropriate. [...]
2024-01-07T11:46:01-05:00GP GPhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;d367ec04.2401Re: GPQ Testing for Media
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;de012287.2401
Dear team,<br><br>These are few FAQ from USP for reference ,<br><br>6. Is it necessary to test the growth promotion on all received batches or<br>does it serve just for microbiological validation? Do we have to test the<br>growth promotion of diluted broth?<br><br>Growth promotion must be tested for each new batch of medium. Growth<br>promotion must be checked on agar media and nutritive broth but not on<br>diluted broth. [...]
2024-01-07T11:43:51-05:00GP GPhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;de012287.2401Re: Changes to ATCC 9027 P. paraeruginosa
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;13a4a336.2401
The name of *Pseudomonas aeruginosa *strain (ATCC 9027<br><https://www.atcc.org/products/9027>) was changed to *Pseudomonas<br>paraeruginosa.* This change is in response to phylogenomic and comparative<br>genomic studies performed by Rudra et al<br><https://www.microbiologyresearch.org/content/journal/ijsem/10.1099/ijsem.0.005542>.<br>that identified two distinct clades of *P. aeruginosa*. Strains in Clade-2<br>were transferred to the novel species *P. paraeruginosa* with ATCC 9027<br><https://www.atcc.org/products/9027> designated as the type strain. [...]
2024-01-06T06:48:56+03:00Rashid Kihwelohttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;13a4a336.2401GPQ Testing for Media
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;d5d20664.2401
Hello,<br>I am wondering what other companies are doing regarding growth promotion testing of media and "comparison" to previously acceptable lots?<br>Looking for input on both liquid and solid media. General media (TSA/TSB) is fine.<br>Any advice is appreciated.<br><br>Alison Berman, MFS<br>Associate Manager - Microbiology<br>Quality Control<br><br>[AMR_Logo_for Email Signatures_19DEC]<br><br>O 631.924.4000 ext. 57379<br>aberman@americanregent.com<mailto:aberman@americanregent.com> \\ americanregent.com<br><br>CONFIDENTIALITY NOTE: This e-mail and any attachments are confidential and may be protected by legal privilege. If you are not the intended recipient, be aware that any disclosure, copying, distribution or use of this e-mail or any attachment is prohibited. If you [...]
2024-01-05T21:14:26+00:00Berman, Alisonhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;d5d20664.2401Re: Changes to ATCC 9027 P. paraeruginosa
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;12052de4.2401
Erin,<br>You should not change the strain you are using at this time.<br><br>My expectation is that USP will (eventually) update the name of the referenced ATCC strain. This is not the first time that one of the ATCC reference strains has had a name change. With the current revision process I would hope that the name change will occur within the current calendar year.<br>Other members of the forum will likely chime in if they have insight on USP's plans. [...]
2024-01-05T20:06:59+00:00Kelley, Dalehttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;12052de4.2401Re: State Regulation of Cometic/Personal Care Preservatives
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;1a650f7a.2401
They should rename these laws as the Cosmetic Microbial Contamination Act.<br><br>Rick Jakober<br>VP Laboratory Services<br>Perritt Laboratories, Inc<br>www.perritt.com<br><br>Sent from my iPhone<br><br>> On Jan 5, 2024, at 09:57, Donald English <donaldgale.english@gmail.com> wrote:<br>><br>> Dear all,<br>><br>> I suspect that most cosmetic/personal care companies have been<br>> involved in registering their manufacturing facilities and listing<br>> their product formulations with the FDA due to MoCRA. However,<br>> everyone should be aware that MoCRA does not prevent states from<br>> prohibiting the use of or limiting the amounts of a cosmetic/personal<br>> care ingredient in a product [...]
2024-01-05T16:44:49+00:00Rick Jakoberhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;1a650f7a.2401Changes to ATCC 9027 P. paraeruginosa
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;cd8741af.2401
Hello PMF List,<br><br>Reaching out today to see if anyone has an update on the USP's plan to<br>address the recent change to ATCC strain 9027 from* aeruginosa *to<br>*paraeruginosa*?<br><br>We are trying to determine the continued acceptability of using strain 9027<br>for method suitability work (USP <51>, <61>, <62>, <71>) or whether we<br>should immediately adopt a different or secondary *P. aeruginosa* strain<br>for this work? [...]
2024-01-05T10:16:51-05:00Erin Thanehttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;cd8741af.2401Re: State Regulation of Cometic/Personal Care Preservatives
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;b32dc7ad.2401
Don makes a good point.<br><br>States setting preservative requirements makes it difficult for cosmetic<br>manufacturers in formulating products as the choice of preservative systems<br>decreases, so additional federal regulation may be preferable.<br><br>Larger states like California can drive industry practices as we have seen<br>with automobile emission standards.<br><br>Tony<br><br>On Fri, Jan 5, 2024 at 9:50 AM Donald English <donaldgale.english@gmail.com><br>wrote: [...]
2024-01-05T10:12:19-05:00Tony Cundellhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;b32dc7ad.2401Re: State Regulation of Cometic/Personal Care Preservatives
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;2b9bda7.2401
And what happens when outbreaks of staph and pseudo occur? The road to hell is paved with good (or maybe bad) intentions.<br><br>Sent from my iPhone<br><br>> On Jan 5, 2024, at 9:53 AM, Donald English <donaldgale.english@gmail.com> wrote:<br>><br>> Dear all,<br>><br>> I suspect that most cosmetic/personal care companies have been<br>> involved in registering their manufacturing facilities and listing<br>> their product formulations with the FDA due to MoCRA. However,<br>> everyone should be aware that MoCRA does not prevent states from<br>> prohibiting the use of or limiting the amounts of a cosmetic/personal<br>> care ingredient [...]
2024-01-05T10:07:01-05:00fsett1http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;2b9bda7.2401Re: Total Viable Spore Count
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;d87e4008.2401
Sude,<br>I have another read. When the USP wrote their spore performance chapter we<br>found that BI manufacturers were adjusting their spore account to<br>accommodate fluctuation in D-value. Watch was the result of your contact<br>with the BI manufacturer?<br>Tony<br><br>On Fri, Jan 5, 2024 at 9:47 AM Sude Kuruoglu <kuruoglusude@gmail.com> wrote:<br><br>> Hi,<br>><br>> I mean that I didn't get the recovery I needed to get. At the and of the<br>> 48th hour, I did not see enough growth to achieve a 50-300% recovery.<br>><br>> Knutsen, Chris <<br>> 0000000b634bad0b-dmarc-request@lists.microbiologynetwork.com>,<br>> 4 Oca 2024 Per, 18:03 tarihinde [...]
2024-01-05T09:56:03-05:00Tony Cundellhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;d87e4008.2401State Regulation of Cometic/Personal Care Preservatives
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;bd17d649.2401
Dear all,<br><br>I suspect that most cosmetic/personal care companies have been<br>involved in registering their manufacturing facilities and listing<br>their product formulations with the FDA due to MoCRA. However,<br>everyone should be aware that MoCRA does not prevent states from<br>prohibiting the use of or limiting the amounts of a cosmetic/personal<br>care ingredient in a product formulation. Because of MoCRA, it is very<br>possible that most companies are unaware that some states in the<br>United States are now prohibiting the use of certain types of<br>preservatives in product formulations starting in January 2025. [...]
2024-01-05T08:34:47-05:00Donald Englishhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;bd17d649.2401Re: Total Viable Spore Count
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;72386f6b.2401
Hi,<br><br>I mean that I didn't get the recovery I needed to get. At the and of the<br>48th hour, I did not see enough growth to achieve a 50-300% recovery.<br><br>Knutsen, Chris <0000000b634bad0b-dmarc-request@lists.microbiologynetwork.com>,<br>4 Oca 2024 Per, 18:03 tarihinde şunu yazdı:<br><br>> Sude:<br>> What do you mean by "...it doesn't work."? What are you observing?<br>><br>> Chris Knutsen, PhD<br>> Scientific Director| Microbiology Center of Excellence<br>> Analytical Strategy and Operations<br>><br>> Office +1 732-227-5375<br>> Mobile +1 609-751-8362<br>><br>> Love Diversity... embrace inclusion<br>> Bristol Myers Squibb<br>> 1 Squibb Drive<br>> New Brunswick, [...]
2024-01-05T08:45:25+03:00Sude Kuruogluhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;72386f6b.2401Re: feedback request
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;7d56420e.2401
Hi David<br>Firstly, thank you for your efforts with the PMFList. I find it an informative way to share common challenges, and I personally find the FDA regulatory actions and Updates to Compendia sections the most useful for the role I currently have.<br>Best Regards<br>Morven<br><br>Confidential - Company Proprietary<br>From: The Pharmaceutical Microbiology Forum Email List <PMFLIST@lists.microbiologynetwork.com> On Behalf Of David Porter<br>Sent: Tuesday, December 26, 2023 9:36 AM<br>To: PMFLIST@LISTS.MICROBIOLOGYNETWORK.COM<br>Subject: [PMFLIST] feedback request [...]
2024-01-04T21:44:07+00:00Mcalister, Morven Bhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;7d56420e.2401Re: Total Viable Spore Count
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;be2065c6.2401
Sude:<br>What do you mean by "...it doesn't work."? What are you observing?<br><br>Chris Knutsen, PhD<br>Scientific Director| Microbiology Center of Excellence<br>Analytical Strategy and Operations<br><br>Office +1 732-227-5375<br>Mobile +1 609-751-8362<br><br>Love Diversity... embrace inclusion<br>Bristol Myers Squibb<br>1 Squibb Drive<br>New Brunswick, NJ 08903<br><br>bms.com / LinkedIn / Twitter / Facebook / Instagram<br><br>-----Original Message-----<br>From: The Pharmaceutical Microbiology Forum Email List <PMFLIST@lists.microbiologynetwork.com> On Behalf Of Sude Kuruoglu<br>Sent: Wednesday, January 3, 2024 12:47 AM<br>To: PMFLIST@LISTS.MICROBIOLOGYNETWORK.COM<br>Subject: [PMFLIST] Total Viable Spore Count [...]
2024-01-04T14:05:52+00:00Knutsen, Chrishttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;be2065c6.2401Re: Total Viable Spore Count
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;ab227181.2401
Are you using this method for the Apex BI? If you are and you are not getting good results I would confirm with the Apex supplier. This method has been optimized for their BI.<br><br>> On Jan 3, 2024, at 6:31 PM, Sude Kuruoglu <kuruoglusude@gmail.com> wrote:<br>><br>> Hello PMFList,<br>><br>> I need an alternative method for disk bioindicator total viable spore<br>> count. The method I used before in the attachment. But it doesn't work. Can<br>> you help me with this?<br>><br>> Thanks in advance,<br>> Sude<br>><br>> ------------------<br>> The PMFList is supported by our [...]
2024-01-03T18:48:10-05:00mjm@microbiologyconsultants.comhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;ab227181.2401Re: feedback request
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;7bd5518a.2401
Hi David,<br>It is a great resource. All useful but if I had to list in descending order to myself, it would be,<br>Updates to Compendia<br>FDA Regulatory Actions<br>Archives<br>White Papers<br>E-books/Training<br>YouTube videos<br>Weekly Bulletins<br>Reviews<br><br>Thanks & Best Wishes for 2024<br><br>Derek<br><br>Dr. Derek Freeman<br>Principal DFMicro<br>Microbiology & QA Consultants
2024-01-03T21:25:14+00:00D Freehttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;7bd5518a.2401Re: feedback request
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;f248d3c4.2401
Also agree with Tim and Joel; I use the information listed with the exception of You Tube. I have referred a number of clients to PMF as an information source and I continue to learn from the content that is made available.<br><br>Many thanks,<br><br>Shannon Wills<br>MicroPharm LLC<br>QC Microbiology, Quality Systems Consulting<br>Cedar Park, TX<br>Cell: (512) 567-5764 [...]
2024-01-03T14:00:49+00:00Shannon Willshttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;f248d3c4.2401Re: Filtration Testing over Multiple Plates
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;a4a0605e.2401
Hi Jerrrod-<br><br>Which one of these statements more aligns with how you use the term “antifungal”?:<br><br>1. The material kills molds, fungus, spores, etc…<br><br>OR<br><br>1. Mold and fungus is unable to grow in the presence of this material (if it’s unable to grow because the material kills mold and fungus, choose option 1). [...]
2024-01-03T13:39:29+00:00Kallay, Jonhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;a4a0605e.2401Total Viable Spore Count
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;b86d488c.2401
Hello PMFList,<br><br>I need an alternative method for disk bioindicator total viable spore<br>count. The method I used before in the attachment. But it doesn't work. Can<br>you help me with this?<br><br>Thanks in advance,<br>Sude
2024-01-03T08:46:37+03:00Sude Kuruogluhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;b86d488c.2401Re: Filtration Testing over Multiple Plates
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;5e07c168.2401
Jerrod,<br><br>Two issues I see here. The first is why try to enumerate mold in a material<br>that is highly antifungal and secondly why test at a sensitivity<br>considerably lower than the specification.<br><br>Tony<br><br>On Tue, Jan 2, 2024 at 12:40 PM Jerrod Weidenfeller <<br>jweidenfeller@nexuspharma.net> wrote:<br><br>> Hello PMFList,<br>><br>> I have a raw material that is antifungal at very low concentrations. I<br>> have found a concentration in which mold is recoverable, but it ends in a<br>> result double than the accepted specification. Is testing twice over 2<br>> plates to reach the desired filtration amount an [...]
2024-01-02T23:18:09-05:00Tony Cundellhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;5e07c168.2401Re: Filtration Testing over Multiple Plates
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;807c79d2.2401
Dear Jerrod,<br><br>Are you sure that your recovered mold is not resistant to the anti-fungal activity of your raw ingredient?<br><br>Don<br><br>Donald J. English Microbiological Quality Consulting LLC<br>Florham Park, New Jersey 07932<br><br>Sent from my iPhone<br><br>> On Jan 2, 2024, at 12:42 PM, Jerrod Weidenfeller <jweidenfeller@nexuspharma.net> wrote:<br>><br>> Hello PMFList,<br>><br>> I have a raw material that is antifungal at very low concentrations. I have found a concentration in which mold is recoverable, but it ends in a result double than the accepted specification. Is testing twice over 2 plates to reach the desired filtration amount [...]
2024-01-02T17:36:19-05:00Donald Englishhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;807c79d2.2401Re: feedback request
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;1e20adcc.2401
I agree with Joel. I use all your information to help our clients as well as update our internal knowledge.<br><br>Sincerely,<br><br>Tim Cser<br>Senior Technology Specialist<br>Commercial Applications<br>MilliporeSigma<br>916-759-1401<br><br>-----Original Message-----<br>From: The Pharmaceutical Microbiology Forum Email List <PMFLIST@lists.microbiologynetwork.com> On Behalf Of Joel Russo<br>Sent: Tuesday, December 26, 2023 8:26 PM<br>To: PMFLIST@LISTS.MICROBIOLOGYNETWORK.COM<br>Subject: Re: [PMFLIST] feedback request<br><br>[WARNING - EXTERNAL EMAIL] Do not open links or attachments unless you recognize the sender of this email. If you are unsure please click the button "Report suspicious email" [...]
2024-01-02T19:43:28+00:00Timothy Cserhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;1e20adcc.2401Re: Filtration Testing over Multiple Plates
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;b33b6b92.2401
Yes, in my experience if you test the TOTAL sample volume over multiple<br>plates and add the results, then you can report the additive result. If,<br>as you described, your raw material is "antifungal at very low<br>concentrations", you may want to consider performing studies to eliminate<br>the need for TYMC testing (in the absence of knowing exactly the intended<br>use of your raw material). Liken it to the "self-sterilizing" concept.<br>Not to be confused with using preservatives as a substitute for cGMPs (USP<br><51>). [...]
2024-01-02T14:03:56-05:00Bob Westneyhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;b33b6b92.2401Re: feedback request
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;dd21787e.2401
Hello Dr. Porter,<br><br>I will largely echo other's sentiments that the FDA regulatory actions, updates to Compendia, and the Articles/White Papers updates are a extremely useful.<br><br>However, I will go farther in saying that all of the other information is also useful because of it's educational value. I often guide my younger colleagues to the website to try and learn all that they can. For myself, I am always hungry for broader perspectives beyond what I've personally experienced. While I've learned so much from all of your conversations over the years, the perspectives in the other material are more available [...]
2024-01-02T17:39:08+00:00Walter Mensenhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;dd21787e.2401Filtration Testing over Multiple Plates
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;ce019125.2401
Hello PMFList,<br><br>I have a raw material that is antifungal at very low concentrations. I have found a concentration in which mold is recoverable, but it ends in a result double than the accepted specification. Is testing twice over 2 plates to reach the desired filtration amount an appropriate approach to this? [...]
2024-01-02T12:33:46-05:00Jerrod Weidenfellerhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;ce019125.24012023 Foodborne Infection Outbreaks
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;4cb326fa.2312
Pre-cut fruit has been a common source of these outbreaks.<br><br>The FSN Food Safety News states:<br><br>"The most recent outbreak in the headlines is ongoing and has been traced<br>to whole cantaloupe from Mexico. The recalled cantaloupe has been used in a<br>wide variety of fresh-cut products that have also been recalled."<br><br>"The deadly outbreak spans the border, with patients having been documented<br>in the United States and Canada. As of late December, there were 302 people<br>infected in the United States, with four having died. In Canada, there are<br>164 sick people, with seven having died. "<br>Attached is [...]
2023-12-28T10:23:28-05:00Tony Cundellhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;4cb326fa.2312Re: feedback request
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;444ae06e.2312
Hi David,<br><br>What we found very helpful are the following article(s) / information:<br>- FDA Regulatory Actions<br>- Updates to Compendia<br>- Articles/White Papers<br><br>We discuss this internally at our Microbiology department meetings within Byondis.<br>As Alison also mentioned a normal web-based website (probably topic based forum) would be very helpful in the future.<br><br>Thank you and best wishes for 2024l! [...]
2023-12-28T13:25:40+00:00Martijn Bennikhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;444ae06e.2312Re: feedback request
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;d0d66c10.2312
Hello and happy holidays!<br>The compendial updates, FDA reg actions, white papers, and bulletins are most helpful for me.<br>Is there still consideration for a normal web-based forum to be placed on the site that does not go through emails?<br>Thanks<br><br>Alison Berman, MFS<br>Associate Manager - Microbiology<br>Quality Control<br><br>O 631.924.4000 ext. 57379<br>aberman@americanregent.com \\ americanregent.com<br><br>-----Original Message-----<br>From: The Pharmaceutical Microbiology Forum Email List <PMFLIST@lists.microbiologynetwork.com> On Behalf Of Vocke, Jillian<br>Sent: Tuesday, December 26, 2023 11:49 AM<br>To: PMFLIST@LISTS.MICROBIOLOGYNETWORK.COM<br>Subject: Re: [PMFLIST] feedback request [...]
2023-12-27T19:10:22+00:00Berman, Alisonhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;d0d66c10.2312Re: feedback request
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;38a2da41.2312
Hi David,<br><br>I personally see value to all listed with the exception of You Tube Videos.<br><br>Kind Regards,<br>Joel Russo MS CQA<br>President<br>Russo Consulting Group, LLC<br>862-686-5861<br><br>> On Dec 26, 2023, at 3:04 PM, Vocke, Jillian <JVocke@medline.com> wrote:<br>><br>> Hi David,<br>><br>> The FDA Action summaries in particular are extremely helpful. When batches of warning letters are released, I always INTEND to sit down and go through them in case there are lessons relevant to my company, but I often get distracted and deprioritize. Having the letters so nicely categorized with the juicy bits in bulleted form [...]
2023-12-26T23:26:21-05:00Joel Russohttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;38a2da41.2312Re: feedback request
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;3c904e69.2312
Hi David,<br><br>The FDA Action summaries in particular are extremely helpful. When batches of warning letters are released, I always INTEND to sit down and go through them in case there are lessons relevant to my company, but I often get distracted and deprioritize. Having the letters so nicely categorized with the juicy bits in bulleted form is really excellent. Thank you. [...]
2023-12-26T16:49:24+00:00Vocke, Jillianhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;3c904e69.2312Re: feedback request
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;49551f30.2312
Hi David and thank you for championing the PMF Forum. For me the most useful information are FDA and compendial updates. The remaining information can be found by a search engine and I do not believe you need to do the work that someone can readily do on their own. <br>I hope you had a Merry Christmas and have a Happy New Year. <br>Sincerely, [...]
2023-12-26T15:36:03+00:00Frank Settinerihttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;49551f30.2312feedback request
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;888f6abc.2312
Happy end of 2023 to all participants of the PMFList!<br><br>I want to thank you all for your participation in the PMFList this year,<br>and I look forward to much more in 2024.<br><br>As you know, a variety of new content was added to the PMF website (<br>www.microbiologyforum.org). I have received little to no feedback<br>pertaining to whether this new material is useful to you. Given that it<br>takes quite a bit of time to prepare and upload this material (mostly by<br>me, and some others), I am requesting input from as many of you as possible<br>to determine [...]
2023-12-26T09:36:17-05:00David Porterhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;888f6abc.2312Re: USP <61> Suitable ATCC organisms
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;e0b0cfb8.2312
I would like to add my 2 cents to this discussion.<br><br>In 1944, ATCC 6538P was found to be resistant to penicillin by using a Penicillin P2 disk and the labeling of this strain as ATCC 6538P. This resistance was confirmed in the initial characterization at ATCC, but additional investigation using a Penicillin P10 disk did not show any resistance. Furthermore, resistance to Penicillin by this strain has not been confirmed by using modern methods in accordance with Clinical & Laboratory Standard Institute guidelines. [...]
2023-12-24T16:59:10-05:00Donald Englishhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;e0b0cfb8.2312Re: Disposal of microbial waste
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;e3684fb1.2312
This topic has recently come up with regards to my need to perform a PQ on<br>a micro lab autoclave. In addition to reading a number of articles/papers<br>on this topic which state that if autoclaved waste is proven to be sterile<br>(thermocouples and BI's,it can therefore be discarded as "regular"<br>garbage/waste. Additionally, this opinion was shared by the technical<br>advisor of manufacturer of the autoclave in question, but it was also<br>stated that it would be wise to check with the local health authorities<br>to be certain that there are no issues with this practice. [...]
2023-12-24T10:57:10-05:00Peter Liseckihttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;e3684fb1.2312Re: USP <61> Suitable ATCC organisms
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;5ec9e944.2312
Not really the same strain as 6538P is resistant to Penicillin, normally<br>used in antibiotic studies/work.<br><br>On Sun, Dec 17, 2023 at 9:12 AM Néstor Oscar Aversa <nestoraversa@gmail.com><br>wrote:<br><br>> Dejar, as far as I remember it is the same strain.<br>> Best regalos, Nestor<br>><br>> El sáb, 16 de dic de 2023, 15:48, Matthew Poch <mpoch@alnylam.com><br>> escribió:<br>><br>> > To all,<br>> > I wanted to get an opinion on what is considered "such as" when selecting<br>> > an organism for USP <61> suitability testing. Specifically, we have a<br>> firm<br>> > that used Staph [...]
2023-12-23T12:33:13-05:00Peter Liseckihttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;5ec9e944.2312Re: Antimicrobial Effectiveness Test : Estimate of inoculum concentration by turbidimetric method for the challenged organisms
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;43ccbe8.2312
Vishwas,<br>Consider the age of the culture when you prepare the suspensions for turbidity. If the organisms contain some non-replicating cells (dead) then you will get an elevated turbidity but not recover the expected number of microorganisms. Different microorganisms will consume nutrients at a different rate so expect some variability by microorganism and age of culture. Trying younger cultures might help. [...]
2023-12-19T18:03:12+00:00Jessica Chiaruttinihttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;43ccbe8.2312Re: Antimicrobial Effectiveness Test : Estimate of inoculum concentration by turbidimetric method for the challenged organisms
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;3495ae60.2312
Dear Vishwas,<br><br>Originally, McFarland standards were prepared by adding Barium<br>chloride to Sulfuric acid to obtain a Barium sulfate precipitate. By<br>adjusting the volumes of these two reagents, standards of varying<br>degrees of turbidity can be prepared to represent several different<br>concentrations of bacteria. By using the Barium sulfate and Sulfuric<br>acid mixture, there were problems with the original McFarland<br>Standards due to instability, storage, and reproducibility of the<br>resulting suspension. However, it is my understanding that there are<br>now McFarland standards that are prepared from suspensions of latex<br>particles in a buffer solution to overcome the problems in using [...]
2023-12-18T21:34:17-05:00Donald Englishhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;3495ae60.2312Re: [External] Re: [PMFLIST] USP <61> Suitable ATCC organisms
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;c029cbc9.2312
To comply with the USP official test <61> I recommended you use ATCC 6538.<br><br>*Staphylococcus aureus* subsp. *aureus* strain FDA 209P is a whole-genome<br>sequenced bacterium with applications in media testing, sterility testing,<br>and susceptibility testing.<br><br>*Staphylococcus aureus *subsp. *aureus* strain FDA 209 was isolated from a<br>human lesion. This whole-genome sequenced bacterium can be used in testing<br>media, sanitizers, disinfectants, antimicrobial preservatives, and<br>bactericides. This strain is also recommended as a test microorganism for<br>USP chapters <1072>, <2021>, <51>, <61>, <62>, and <71>. [...]
2023-12-18T12:02:54-05:00Tony Cundellhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;c029cbc9.2312Antimicrobial Effectiveness Test : Estimate of inoculum concentration by turbidimetric method for the challenged organisms
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;b79f877.2312
Hello,<br>We are using Densitometer to adjust turbidity for Bacteria and Yeast while inoculating into product for AET. The instrument is calibrated MacFarlane Standards (0.5, 1, 2, 3, 4, 5) and then adjust turbidity to get 1 x 10^8 inoculum. Usually, the viable count is in the range of 1 x 10^5 to 1 x 10^6 for Bacteria and Yeast. However, sometime variation observed for Staphylococcus aureus using validated method. [...]
2023-12-18T14:31:35+00:00Vishwas Kelkarhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;b79f877.2312Re: [External] Re: [PMFLIST] USP <61> Suitable ATCC organisms
http://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;60b0e365.2312
Hi Tony,<br><br>Thank you for your quick response. A follow up question. Based on the paper you cited is it accurate to state that the current ATCC 6538 was made from FDA 209P (i.e. ATCC 6538P). if so, why are they grouped under different WDCM numbers?<br><br>[cid:image001.png@01DA3194.4D94F720]<br><br>[cid:image002.png@01DA3194.5FB21C80]<br><br>Matthew Poch<br><br>Quality Control Assoc Director<br><br>Alnylam Pharmaceuticals [...]
2023-12-18T14:27:12+00:00Matthew Pochhttp://lists.microbiologynetwork.com/scripts/wa?A2=PMFLIST;60b0e365.2312