Tyvek Blister Pack Testing Requirements - ISO 11607

mobylad

Starting to get Involved
#1
Is it neccessary to do leak integrity on a Tyvek Blister Pack contaning a medical device? Is Burst Test and Peel Test (visual) enough? The Blister pack contains a glass vial, so the blister pack would be considered a secondary package? :confused:
 
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pkost

Trusted Information Resource
#2
Re: Iso 11607

Would the glass vial be dropped into the sterile field? I would think there is an expectation that the glass vial is sterile therefore you can't really consider the blister pack as "secondary"

The standard does not specify exactly what tests should be carried out; it just says that you should justify the decision in selecting them. I would suggest you risk assess the packaging and use that to justify whether to include leak testing or not.
 

mobylad

Starting to get Involved
#3
Re: Iso 11607

Yes, I see your point.. Yes..the glass vial would be used in a sterile field. This brings up a different question: The Blister Pack would also be dropped into the sterile field, as the vial is removed from the blister pack in the sterile field/area?? Do you know how this is normally handled as the outside sterility of the vial can be ensured (leak test, seal strenght..etc) but I'm wondering how can one guarantee the sterility of the outside of the blister pack? as the outside of the blister pack is packaged within a non-airtight box.
 

pkost

Trusted Information Resource
#4
The blister will never be "dropped" into the sterile field otherwise the field would no longer be sterile.

There are a number of approaches. The ideal is a double blister approach - this is where the outer blister contains another sealed blister. In the theatre, the non sterile staff handle this outer blister, they carefully remove the tyvek lid then invert the blister so that the inner (and sterile) blister drops into the sterile field and then be handled by the scrubbed team. The non sterile team have no need to touch the inner blister and the sterile device (still sealed in the inner blister) is never outside the sterile field.

If you don't want to go down the double blister approach then after the non sterile member of staff has pealed back the lid, the scrub nurse (who is sterile) reaches inside and pulls out the contents; the scrub nurse has to take care not to contact the outside of the blister otherwise they have to re-scrub.

I am assuming that your glass vial is not implanted, so it can act as the "inner" blister. I would take some time to consider whether you can either drop the vial into the field (i.e. it won't be secured in the blister) or how it can be very easily removed from the blister by the scrub nurse (i.e. it is secured in the blister so won't rattle around)


edit: It has just occured to me that I have given a response assuming that your device is used in theatre. This may not be the case. I am less clear how sterile procedures are carried out outside of a theatre environment however procedure packs typically have sterile wrapping which opens onto a work surface. Anything within the wrap is sterile (any instruments needed) and this provides an impromptu sterile field. Anything else that is needed would typically be dropped into the field (assuming it's sterile). Due to the reduced number of sterile staff in some of these procedures (frequently only the doctor) then it is preferable to drop the sterile product in instead of having them reach into a sterile blister to reach it.
 
Last edited:
T

The Specialist

#5
Is it neccessary to do leak integrity on a Tyvek Blister Pack contaning a medical device? Is Burst Test and Peel Test (visual) enough? The Blister pack contains a glass vial, so the blister pack would be considered a secondary package? :confused:

Before I respond I would like to ask a couple of questions...

What (in terms of your process) is the function/purpose of the blister pack?

Is it an empty glass vial that you are placing into the blister pack?
 
Last edited by a moderator:

mobylad

Starting to get Involved
#6
Blister pack is to keep the outside of the vial clean.
The vial is not empty..The vial contails the medical device (liquid form)
 
M

MIREGMGR

#7
If the outside of the filled glass vial must be sterile, then the outer pack is a sterile barrier system. Thus it must be engineered and validated as a sterile barrier system.
 

Ronen E

Problem Solver
Staff member
Moderator
#8
...And to address the original question -
Burst tests and peel tests essentially test the seal strip weld strength, i.e. a strong weld could pass even if it's not properly sealing.
If you wish to maintain a sterile barrier then yes, leak test is recommended.
Please also note that as long as the barrier is not exposed to liquid, to maintain a sterile barrier, it doesn't necessarily have to be airtight (refer to the tortuous path principle; this is basically how Tyvek works as well).

Cheers,
Ronen.
 
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