Checklist for ISO 11607-2:2006 - Medical Device Packaging - Information needed

[meimei]

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.


Best Regards
Meimei

 

[Jimmy the Brit]

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

 

[meimei]

Hi Jimmy,

for the reply.

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

Rgrds
MeiMei

 

[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

 

[Jimmy the Brit]

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

 

[adlcisa]

Hi,
our new customer wants to pack its IV Administration Sets only in microforate PE pouches; I'm loocking for a Standards for PE Packaging, but I found only for nonwoven materials or PA/PE film AND paper medical grade...
where I can find an equivalent Standard, but for only PE made pouches?
many thanks in advance,
kind regards,
Adlcisa

 

[powens]

Hello, I hope that this thread is close enough to my question. I have 2 parts to this question. Please assume that the client or company in question makes a medical device and packages it in double Tyvek pouch:

1) I wanted to see if anyone has a shared or public domain line by line, or at least key section guide to 11607 Part 1 and Part 2 (what are specific responses/practices to a given section from 11607?

I guess that this is going to have only the guide/primer/suggested practices for a given line or section. We cant have people actually distributing a "marked up" copy of 11607, that wouldn't fly.

2) The second part, is what are the key auditor question or drill in spots on Part 1 and Part 2.

I am sure that I can add some clarification to this thread.

Thanks

Pat

 

[X.Liu]

I have a question associated with this standard but I could not find very clear answer.
It is about the label on top of microbial barrier system. Our product has a product label on the lid of pouch. Paper base, backside adhesive and ink/paint could be toxic and product could be badly conteminated if no proper design and validation is carried out. What tests we should consider? Biocompatibility?

 

[powens]

Hello all,

Please feel free to calibrate my response.

The start up way:
1) Build your intended 10993 series product samples.
2) Package your product samples in your sterile barrier.
3) Gas or Irradiate product (typ 2X).
4) Send packaged product to test lab for 10993 series testing. Lab personnel removes product from sterile barrier and test product for selected 10993 series test.

To me this seems defendable. Everything that is going to touch the patient and the sterile staff has been exposed to the inside of the sterile barrier and it's subsequent processing.

You could really argue that your test samples should have been exposed to accelerated aging conditions to maximize any outgassing etc. effects (real time duplication testing of course).

Big company way:
1) I don't know. I haven't worked on big company packaging bio compatibility project. Do big companies send out just packaging materials and labeling for seperate biocompat testing? Why? Is this a specific requirment of 11607?

If the outside of the sterile barrier does not touch the product or the sterile field staff, then it should be very low risk to the patient. Is the concern more for the circulating staff? Or very worst case, imagined toxic airbourne toxic molecules floating across the room from icorrectly chosen toxic label glue?


Thoughts, comments, calibrations?

I hope that this helps,

Thanks

Pat

 

[X.Liu]

As I am looking at the similar issues, I dug a bit about it. AAMI TIR22:2007 discussed safety consideration of packaging material (E.3). My understanding is that this is not only the sterile barrier, but also the carton, label, IFU, etc. Bare in mind that the sterile barrier is not a insolation of chemical, toxic out-leach over the years of shelf life from carton, paper, ink, glue can penatrate and contaminate the product.