B
Hi Guys,
I'm new to this site and relatively inexperienced in the Quality Sector.
Basically I've been thrown in at the deep end and handed a Sterility Project for our components and assemblies and I'm looking for some further information.
I've been referring to the various ISO and USP standards:
ISO 10993-1, Biological evaluation of medical devices ? Part 1
ISO 11137: Sterilization of health care products - Radiation Parts 1 and 2
ISO 11737: Sterilization of medical devices - Microbiological methods Parts 1 and 2
ISO 13485:2012, Medical devices - Quality management systems
ISO 14971:2012, Medical Devices ? Application of risk management to medical devices
ANSI/AAMI ST72: 2011, Bacterial endotoxins - Test methodologies, routine monitoring, and alternatives to batch testing
US Pharmacopeia: Chapter <61> Microbial limit tests
US Pharmacopeia: Chapter <71> Sterility tests
US Pharmacopeia: Chapter <85> Bacterial endotoxins test
I don't have access to the following (Anybody know where I could find it online?):
ISO 15843:2000, Sterilization of health care products - Radiation sterilization
We are in essence a middle link in the supply chain, we receive components in, assemble them in a cleanroom, and provide to our customers.
I have asked our suppliers for any Bioburden information they can supply and so far those requests have come up with nothing.
We have quite a large number of components to be sent for Bioburden testing and I'm trying to reduce this number and that's where I'm hoping you guys can come in.
I'm new to this site and relatively inexperienced in the Quality Sector.
Basically I've been thrown in at the deep end and handed a Sterility Project for our components and assemblies and I'm looking for some further information.
I've been referring to the various ISO and USP standards:
ISO 10993-1, Biological evaluation of medical devices ? Part 1
ISO 11137: Sterilization of health care products - Radiation Parts 1 and 2
ISO 11737: Sterilization of medical devices - Microbiological methods Parts 1 and 2
ISO 13485:2012, Medical devices - Quality management systems
ISO 14971:2012, Medical Devices ? Application of risk management to medical devices
ANSI/AAMI ST72: 2011, Bacterial endotoxins - Test methodologies, routine monitoring, and alternatives to batch testing
US Pharmacopeia: Chapter <61> Microbial limit tests
US Pharmacopeia: Chapter <71> Sterility tests
US Pharmacopeia: Chapter <85> Bacterial endotoxins test
I don't have access to the following (Anybody know where I could find it online?):
ISO 15843:2000, Sterilization of health care products - Radiation sterilization
We are in essence a middle link in the supply chain, we receive components in, assemble them in a cleanroom, and provide to our customers.
I have asked our suppliers for any Bioburden information they can supply and so far those requests have come up with nothing.
We have quite a large number of components to be sent for Bioburden testing and I'm trying to reduce this number and that's where I'm hoping you guys can come in.
- Do I need to have all components tested for BioBurden Levels and then classify them accordingly into family products?
- Can I classify them according to manufacturing location, process, raw materials? For example, if I have 5 identical components with the only difference being increasing size or internal diameter, would this not automatically qualify the largest as the master product? Or do I need to substantiate that by having all components tested first and using the component with the highest levels?
