I'm working in suppling packaing material for medical device company, doing Blown film and web printing.
Recently, one of our new customer requested us to fill up a checklist for ISO11607-2:2006.
Will need some advise from anyone who know this standard, how will this standard applicable to my industry.
Hello meimei,
If you are in the business of
sterile medical device packaging then this document is absolutely vital for you.
ISO11607 (2006) "Packaging for terminally sterilized medical devices" part 1 defines the requirements for all medical packaging materials, sterile barrier systems and packaging systems. This covers preformed barriers, microbial retention properties, sterilization process compatibility, labelling compatibility, storage, transport, performance testing and design of packaging systems.
Part 2 states the validation requirements for forming, sealing and assembly of packaging operations. This defines IQ,OQ and PQ expectations as well as process control considerations.
Both of these documents are supported by AAMI TIR22:2007, which offers guidance on the interpretation of 11607. This is an awesome document with very clear instructions about how to demonstrate compliance with both parts of the standard. If you are not already familiar with them, it would also be valuable for you to look at some of the ASTM methods for packaging validation, shelf life validation, defect detection etc.. as these are called out by 11607.
As a purchaser of medical device packaging I would not even look at a supplier that did not claim compliance with ISO11607.
I hope this helps. Regards,
Jimmy