AAMI ISO TIR16775:2014 pdf download – Packaging for terminally sterilized medical devices – Guidance on the application of ISO 11607-1 and ISO 11607-2
The following aspects should be considered:
a) The size of the pouch and the strength of the packaging materials should be based on the medical device which is going to be packaged. Items either too large for a package or with sharp edges will put extra pressure on the seals and the materials. This may cause rupture. There should be enough space to make seal closure possible. Too many small items in the sterile barrier system may cause the items to move around, rupture the seal, penetrate or abrade the package materials. Thin or fragile materials can be damaged during handling, transport, and distribution.
b) If not specified otherwise by the manufacturer the preformed sterile barrier system should be filled up to a maximum of 75 % of the inner surface area of the porous side. Care should also be taken to ensure that the distance from the seals is increased for products of greater height.
c) When two pouches are used, the inner pouch should be able to move within the outer pouch. This allows penetration of the sterilant and prevents the pouches from sticking together during the sterilization process. Folding of the inner pouch in order to fit into the outer pouch or folding of the outer pouches should be avoided in order to prevent stressing or damage to the sterile barrier system. For combining two pouches made from film and porous material it is important that film meets film and porous material meets porous material for identification of content and permeation of sterilant.
d) All pouch seals, including closure seal, should be smooth, i.e. without folds, bubbles, or wrinkles.
e) Self-seal pouches and those closed with tape may provide less security than heat sealed pouches. Sealing procedure should dictate that folds and closures should not be skewed, and care should be taken to ensure that both corners are well sealed, in order to ensure a complete closure across the entire end. Correct tape placement is critical to provide complete closure and thus sterile barrier system integrity. Special attention should be paid to proper method of closure to ensure package integrity.
f) Sealing devices should be able to control and monitor critical process parameters (e.g. temperature, pressure, sealing time/speed) in accordance with their validation criteria (e.g. alarms, warning system or machine stop in the event of any critical process parameter deviation). Operators should not modify critical process parameters unless they have been suitably trained, fully comply with appropriate operating procedures and stay within the validation process. The sealer should be capable of attaining the sealing conditions suggested by the preformed sterile barrier system manufacturer. Sealing devices manufactured and intended for preformed sterile barrier systems should be used.
g) Closing accessories that compress the package or medical device should not be used (e.g. ropes, string, elastic bands, paperclips, staples or similar items).
h) The pouch should be loaded so that the enclosed medical device will be presented aseptically. For instance, the grip of the medical device should be placed toward the opening end. It should be noted that the seal areas are considered non-sterile when opened. [1 08]
i) The pouch should be opened according to the manufacturer instructions, if there is a specific orientation needed to prevent fibers delamination when opening that orientation should be followed. The formed package should show by design which direction the packaging has to be opened (e.g. arrow sign, shape of seal).