Hi,

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.

:thanx:
Best Regards
Meimei

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

Hi Jimmy,

:thanks: for the reply.

Think I have to read the standard in detail to understand it.

Rgrds
MeiMei

Dear Jimmy,

I had read through the ISO 11607 standard. To my understanding, part 1 is more appliable to my industry, which we supply the top and bottom web to medical device company for their packaging.

AS for part 2, I'm not sure about it. Will you able to elevate more?

Thanks in advance

Rgrds
Meimei

I had read through the ISO 11607 standard. To my understanding, part 1 is more appliable to my industry, which we supply the top and bottom web to medical device company for their packaging.

AS for part 2, I'm not sure about it. Will you able to elevate more?
Hi Meimei,

I agree with your primary compliance responsibility being with Part 1 of ISO11607, however I assume you sell these packaging materials on the basis that, under the correct time, temperature and pressure, they will form an impermeable (or at least bacterial retentive) seal. In that case you still have to validate the integrity of the potential seal, and for that you will need part 2, as well as numerous ASTM methods, and probably ISO5636 part 5, the Gurley test of air permeance of sterile barrier system paper packaging.

I recommend that you read AAMI TIR22:2007 and choose the methods that would make sense for you to comply with, assuming you make some form of label claim about the type of seal your materials can produce.

Hope this helps,

Regards,

Jimmy