Renee,
Endotoxin is more of a sterility-indicating test. For terminally sterilized products, sterility is certainly stability indicating. However, if microorganisms find their way into the product there is not enough nutrients in most products to sustain them and they would die during the product shelf-life. Once sterility testing is performed at the end of shelf life or at other stability intervals (depending on your protocol design), there would be no viable (living) microorganisms to grow in the sterility test nutrient broths which would result in a falsely passing sterility test. The dead bodies of the microorganisms can be discovered with the use of an endotoxin test, though. So, these tests are used together to establish sterility at end of shelf life traditionally. To avoid using the combination of endotoxin and sterility testing at expiry, I suggest using container closure integrity testing as is allowed per the FDA guidance "Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products". Here is the link:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/container-and-closure-system-integrity-testing-lieu-sterility-testing-component-stability-protocol
If you show that your product was sterile at release (either through traditional sterility testing or parametric release using validated autoclave parameters) and then show that your container closure system remained intact through the product's shelf life, this is just as good if not better than a traditional sterility test.
Best,
Justin Morell
Lead QC Quality Engineer
T: 314-595-0917 | C: 314-920-5041 | W: curiumpharma.com
2703 Wagner Place, Maryland Heights, MO 63043
-----Original Message-----
From: Pharmaceutical Stability Discussion Group <[log in to unmask]> On Behalf Of Renee Mickowski
Sent: Tuesday, August 9, 2022 7:28 PM
To: [log in to unmask]
Subject: [EXT]: [PSDGLIST] LAL and sub-visible testing as part of stability testing
Hello,
Our company is TSP manufacturer and about a couple of years ago due to regulatory audit, we introduced LAL and sub-visible testing into our finished product specification. I have been wondering why the same testing were not included in the stability testing program.
Does anyone have any input whether if we need to do these testing (i.e. are they stability-indicating tests)? Any expert advise is appreciated.
Kind regards,
Renee Mickowski
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The nature of this service is to provide a medium for communication. The specific statements and endorsements of individuals participating in the discussions are not necessarily those of The Microbiology Network, Inc., the PSDG, or the sponsors of the list.
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The PSDGList (http://microbiol.org/psdglist.htm) is operated from The Microbiology Network (http://www.microbiol.org) and supported by our sponsors as a service to the scientific community. Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
ScienTek - http://www.iStability.com/
Provides iStability - Web browser based software for stability management,
reporting, testing/data management, statistical data analysis, and more.
BahnsonEnvironmental Specialties - http://www.eschambers.com/
Manufacturer of Quality Stability Chambers, Warm & Cold Rooms, Freezers and
Ultra Low Storage Chambers with Complete Validation, Maintenance & Calibration
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