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October 2019

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Subject:
From:
"Housel, Mariangela" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 11 Oct 2019 11:47:47 +0000
Content-Type:
text/plain
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text/plain (212 lines)
No- it is not a monographed product and it is a non-sterile powder.  The specs are being updated to include this testing.  They already have the pre-sterilization bioburden as well.  I understand what you are saying and that makes sense.  The API seems inhibitory in nature at least to the bacteria so I see no benefit in performing the test.
Thank you for your help Tim.

Angela


-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Timothy Cser
Sent: Thursday, October 10, 2019 11:33 AM
To: [log in to unmask]
Subject: Re: [PMFLIST] USP 61/USP 62 Testing

Hi Angela.  Is the API a monographed product?  Also, what are the specifications for that API?  Is it a sterile liquid, non-sterile powder, etc.  Firms have different procedures for testing their API's.  Some firms use a sterile API because that's what they need, even though it's not considered a sterile finished product so they might even do a sterility test on the API.  Other firms use an industry standard of 10 CFU/100mL for pre-sterilization bioburden with a non-sterile API.  Many firms have adopted USP 61 as a standard for these types of products because it is a validated method even though the API isn't a finished product.  The CFU limits in USP 61 might not apply because that API will undergo further processing where they will eventually test the final product but the methodology is tested so you don't need to develop a new method.

Sincerely,

Tim Cser
MilliporeSigma

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Housel, Mariangela
Sent: Wednesday, October 9, 2019 1:08 PM
To: [log in to unmask]
Subject: Re: [PMFLIST] USP 61/USP 62 Testing

Thanks Tim. The recovery issues are with method suitability and it is an API used in a sterile product.  The bacteria. I thought USP 61 and USP 62 were for non-sterile finished product so I am unsure why this test is even being performed. Any information on this would be greatly appreciated.

Sincerely-

Angela

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Timothy Cser
Sent: Wednesday, October 9, 2019 10:23 AM
To: [log in to unmask]
Subject: Re: [PMFLIST] USP 61/USP 62 Testing

Hi Angela.  USP 61 is the standard for sample prep in USP 62.  There are additional enrichment steps in USP 62.......what organisms are you having issues recovering?  Is this just growth promotion or method suitability?

Sincerely,

Tim Cser
MilliporeSigma

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Housel, Mariangela
Sent: Wednesday, October 9, 2019 5:27 AM
To: [log in to unmask]
Subject: [PMFLIST] USP 61/USP 62 Testing

Good Morning everyone- I have a question regarding the sample prep. for USP 61 and USP 62.  Having some issue with USP 62 and no recovery of some of the organisms but USP 61 is working.  I would expect that the same sample prep. (starting dilution) should work for both USP 61 and 62.  Is this the wrong assumption?


Thanks-


Angela Housel
Senior Quality Specialist

(585) 338-5901 (Office)

Email: [log in to unmask]<mailto:[log in to unmask]>



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Science Advisory Board https://secure-web.cisco.com/1fzMr_c6n8SSBX-S9FFFwiFJPOBaa76bK-oeiv92YQKQkz6eK98LFgjOpFHBO6VOlzQLbyS5J5ZLsEDag8t8sBl4uH76BJorjLSo_miN9gNOwEGgkj3N3KxG1glhclDC9PuZ1oSmHNFsjQikwdSVnAKqxPNKGYYtdCUnci6VBEL1uLlA9ojoiH66-xPWdUrkz2HSdJCRi4Ih6BLJceU3g8kfgDKHbSuNj4QJT3DH2-GvXPswYD_Nq6kLWAsu7dZ92ru9yZnnDzxJHuOz7Yjc61ttDniJ-ZwIR358zQU4WCwx9d45Fg5LLKl3MELGxYjL47jG4W9pfaswbdhTKLzkjng/https%3A%2F%2Fwww.scienceboard.net%2F

Steris - http://secure-web.cisco.com/12mUO38unrMTIPIJeEBplgvORMuH809OVVRmN-7FK5LsP4ZCim6t0k-vz8FMLbO9uX3gtmBoTLgnisek6INGlH4lV2d6SsuUDGfu1XKl32HBu1Ljj16krra0j7jLsV1nqxVw-UNDRcr1jbP3FfX83oWgOWDI2OL9S9Lf1IC-swGxALfDtG7ewzDs6F94865QycqlW-nTBotkIn-LkPoPMEGHglhBXdVo1fJ2A5AnOjmUQWcAoZe_-CN8dYEJs4R13t1EXdaDH86a5XzRfXxwwvJHxVvlUdXPLXi8Ib1CiI3DOQJpNCE8DbE1vqfobncY0KClIPKqVI7fhMbGUs9ONsg/http%3A%2F%2Fwww.sterislifesciences.com%2F

Charles River Laboratories - http://secure-web.cisco.com/1Cbhifc4RsVtLAYp6L3qlvEtdhV0qdKTgSV0DxGfkRB0yUSO209jf3Eqvwpv3LYVtTI1U7kDCSRYPQ9fPO9qAO1B00je-R564CLifsShQdjiQnHIMbjhOejDpPIRZCrp6z8B5KNLpMn0lOxtenze58Miv2DucaBYk2BWXDCMc28UwTa4kM92KQiKQ9TKy4Ygpg4JvaKMmvaOnvLMkBbisbs6DqnTZBVx-F0xbrSwS7BTmOK7MvosMBPLqbpbruwYhCVJMOlibDZw4AVQ_4rau1--9uEcjCEtaHVxV6pPrndJ9rUZxLQn1ZIPc8Eaq9QQTpDKzylGl-atttbKL6xQkbw/http%3A%2F%2Fwww.criver.com%2F

Veltek Associates, Inc - http://secure-web.cisco.com/17e4GXEbhTCzXcrvofL1e7Skacl_ccoMSETrbGvnpYIuzHIutfqPuBlneJSGVd-iJJvNTRe6V0_xhFFY7rnCP4D0boH_FuGok98m74tJJ8txgl0b46PzQHjSZVoJhvtH_lJwDNACAYvfx0YVv66L3zbGsjmH_LgmAg_qHISZzpdl-dIX-gsVm4DWZy9v0HuA4hx5WrYUnmx2JqC_iRFHZbVQ9VwUVq7hpqolWXF7_ug4xJBA3WYGPEe1w8tNHyicOJQp4-yh7JGOlEQcvv-SPvHYIOywZW4Che-AnvUn-NZXL2uNR848lPB9dcGIIAlSt2XciXW3YyyrjdnfPIFwQrA/http%3A%2F%2Fwww.sterile.com

Microbiologics, Inc. - http://secure-web.cisco.com/1fcuICJRxhS9yukeKNv1VdncLg-Zg_LrVrZTRiq0cxsDhstO0HomFJkdWDRu782lNdXfdknFlIf4NnftSX9oq3_Siua6UJN5wDRHG1UfJ1lhklj9Lv6e0UVqqcNE3f9NOxbZytgaqGP3aXaRbltARVn7nHvCaHFhW_-ec30ZBqsjef47GZtlrt4kj5gnT3HscE29KcvaNHtt8M0NqlzZspnCp2MeUKj-u3EFGd4fBSwE2kFPr5MsJ8nfQcckgDUtJIp61pJLHB_hSuaAt988GSdhJmlitdgx_eMwUAqV_iDMmhEihd3D5TXVEdPkddvJQmQs1mfsRtAq5ubZhDPhBcw/http%3A%2F%2Fwww.microbiologics.com

BD Industrial Media - http://www.bd.com/ds/

Boston Analytical http://secure-web.cisco.com/1Qoe2Mea7r39BLUu0OtU4KLG5bydMxUtxdP4OueWqwdVoz-_49lSTzhZggyMcXK6C7NO9znS-Uy5LWJmH-_BjnZKtJ8r2ogexcx1KaW3EfRWxx_Mw4qA9JlcAz87ngMQ4L8aLCFeSVv9FuRUpcmo7CPbm49COCsh1ujUOd7ITmWZIl9weIvVhvRHtmIbYljeX0filZKULXeXqCf1orHaPM8JhaRP0yZNOsNzfvmKbGeTYeZEQurM-lGEgJOhYw1AD7l5VfQeW6M5bB049egfw0pJS_rJg1YrVE511jM03we2B3p1uj7YH8LIp5gDUDQAc/http%3A%2F%2Fwww.bostonanalytical.com%2F

Associates of Cape Cod, Inc. - http://secure-web.cisco.com/1rhKa1OT4GFCeK_9aJC9Q8C75F5qC4mAKy1ZvdjTkGVVmnsTKZabnKxNYjKUxGk03LH_TJQRDdRSdJdvrfkfjwv6KE0Pf5lxzLvfRbflHCPj4K5OpWDIN1zMdvWuMN51E9_Ge_6lUfrXvsOsQu1_Gd-JHCYlYzOQh6Q583uP9_WUlmLsqIMbFoKnNtIRbZw1wjhhW0Wwvep8VTqCeC0vTmbiV7YOsWT0laJEtoB4CLK5MyvuNoNglVGbo63GRB5o-edsJ8zFSWM62-GEBmIB-n1wc11uFkt95CZetAFLVw2Rd8JNpwoLP0LYUSTk-mor2gVA2k9zyCoaW_Bl1bDTOxw/http%3A%2F%2Fwww.acciusa.com%2F


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Steris - http://secure-web.cisco.com/12mUO38unrMTIPIJeEBplgvORMuH809OVVRmN-7FK5LsP4ZCim6t0k-vz8FMLbO9uX3gtmBoTLgnisek6INGlH4lV2d6SsuUDGfu1XKl32HBu1Ljj16krra0j7jLsV1nqxVw-UNDRcr1jbP3FfX83oWgOWDI2OL9S9Lf1IC-swGxALfDtG7ewzDs6F94865QycqlW-nTBotkIn-LkPoPMEGHglhBXdVo1fJ2A5AnOjmUQWcAoZe_-CN8dYEJs4R13t1EXdaDH86a5XzRfXxwwvJHxVvlUdXPLXi8Ib1CiI3DOQJpNCE8DbE1vqfobncY0KClIPKqVI7fhMbGUs9ONsg/http%3A%2F%2Fwww.sterislifesciences.com%2F

Charles River Laboratories - http://secure-web.cisco.com/1Cbhifc4RsVtLAYp6L3qlvEtdhV0qdKTgSV0DxGfkRB0yUSO209jf3Eqvwpv3LYVtTI1U7kDCSRYPQ9fPO9qAO1B00je-R564CLifsShQdjiQnHIMbjhOejDpPIRZCrp6z8B5KNLpMn0lOxtenze58Miv2DucaBYk2BWXDCMc28UwTa4kM92KQiKQ9TKy4Ygpg4JvaKMmvaOnvLMkBbisbs6DqnTZBVx-F0xbrSwS7BTmOK7MvosMBPLqbpbruwYhCVJMOlibDZw4AVQ_4rau1--9uEcjCEtaHVxV6pPrndJ9rUZxLQn1ZIPc8Eaq9QQTpDKzylGl-atttbKL6xQkbw/http%3A%2F%2Fwww.criver.com%2F

Veltek Associates, Inc - http://secure-web.cisco.com/17e4GXEbhTCzXcrvofL1e7Skacl_ccoMSETrbGvnpYIuzHIutfqPuBlneJSGVd-iJJvNTRe6V0_xhFFY7rnCP4D0boH_FuGok98m74tJJ8txgl0b46PzQHjSZVoJhvtH_lJwDNACAYvfx0YVv66L3zbGsjmH_LgmAg_qHISZzpdl-dIX-gsVm4DWZy9v0HuA4hx5WrYUnmx2JqC_iRFHZbVQ9VwUVq7hpqolWXF7_ug4xJBA3WYGPEe1w8tNHyicOJQp4-yh7JGOlEQcvv-SPvHYIOywZW4Che-AnvUn-NZXL2uNR848lPB9dcGIIAlSt2XciXW3YyyrjdnfPIFwQrA/http%3A%2F%2Fwww.sterile.com

Microbiologics, Inc. - http://secure-web.cisco.com/1fcuICJRxhS9yukeKNv1VdncLg-Zg_LrVrZTRiq0cxsDhstO0HomFJkdWDRu782lNdXfdknFlIf4NnftSX9oq3_Siua6UJN5wDRHG1UfJ1lhklj9Lv6e0UVqqcNE3f9NOxbZytgaqGP3aXaRbltARVn7nHvCaHFhW_-ec30ZBqsjef47GZtlrt4kj5gnT3HscE29KcvaNHtt8M0NqlzZspnCp2MeUKj-u3EFGd4fBSwE2kFPr5MsJ8nfQcckgDUtJIp61pJLHB_hSuaAt988GSdhJmlitdgx_eMwUAqV_iDMmhEihd3D5TXVEdPkddvJQmQs1mfsRtAq5ubZhDPhBcw/http%3A%2F%2Fwww.microbiologics.com

BD Industrial Media - http://www.bd.com/ds/

Boston Analytical http://secure-web.cisco.com/1Qoe2Mea7r39BLUu0OtU4KLG5bydMxUtxdP4OueWqwdVoz-_49lSTzhZggyMcXK6C7NO9znS-Uy5LWJmH-_BjnZKtJ8r2ogexcx1KaW3EfRWxx_Mw4qA9JlcAz87ngMQ4L8aLCFeSVv9FuRUpcmo7CPbm49COCsh1ujUOd7ITmWZIl9weIvVhvRHtmIbYljeX0filZKULXeXqCf1orHaPM8JhaRP0yZNOsNzfvmKbGeTYeZEQurM-lGEgJOhYw1AD7l5VfQeW6M5bB049egfw0pJS_rJg1YrVE511jM03we2B3p1uj7YH8LIp5gDUDQAc/http%3A%2F%2Fwww.bostonanalytical.com%2F

Associates of Cape Cod, Inc. - http://secure-web.cisco.com/1rhKa1OT4GFCeK_9aJC9Q8C75F5qC4mAKy1ZvdjTkGVVmnsTKZabnKxNYjKUxGk03LH_TJQRDdRSdJdvrfkfjwv6KE0Pf5lxzLvfRbflHCPj4K5OpWDIN1zMdvWuMN51E9_Ge_6lUfrXvsOsQu1_Gd-JHCYlYzOQh6Q583uP9_WUlmLsqIMbFoKnNtIRbZw1wjhhW0Wwvep8VTqCeC0vTmbiV7YOsWT0laJEtoB4CLK5MyvuNoNglVGbo63GRB5o-edsJ8zFSWM62-GEBmIB-n1wc11uFkt95CZetAFLVw2Rd8JNpwoLP0LYUSTk-mor2gVA2k9zyCoaW_Bl1bDTOxw/http%3A%2F%2Fwww.acciusa.com%2F


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Science Advisory Board https://www.scienceboard.net/

Steris - http://www.sterislifesciences.com/

Charles River Laboratories - http://www.criver.com/

Veltek Associates, Inc - http://www.sterile.com

Microbiologics, Inc. - http://www.microbiologics.com

BD Industrial Media - http://www.bd.com/ds/

Boston Analytical http://www.bostonanalytical.com/

Associates of Cape Cod, Inc. - http://www.acciusa.com/


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