12 Processing and packaging options

PROCESSING AND PACKAGING OPTIONS

1. Outer shipping box is securely sealed. Box displays product label, sterile dot indicator and fully traceable lot number and the certificate of sterility.

2. Multilevel interior packaging features two polyethylene box liners. The outer liner provides protection from dust and contamination, particularly if outer box is discarded. A lot- specific Certificate of Compliance with sterile dot indicator is placed between the two liners. The inner liner is closed allows transportation of product to a cleaner, more controlled environment.

3. (3a. and 3b.) Multiple items are packed in a dual barrier packaging system, consisting of an inner and outer easy tear, validated, cleanroom bag. The validated dual barrier packaging system serves both as an additional sterility risk management component and is a key element for contamination risk reduction when transferring apparel into clean areas.

4. Sterile items are consistently folded and packed to ease aseptic donning. Traceable lot numbers are stamped on each Tyvek® IsoClean accessory.

STERILE PACKAGING PROCESS FOR OPTION MS Items are packed in a dual barrier validated packaging system, consisting of an inner and outer easy tear, validated, cleanroom bag. Th e accessories are individually packed and sub-grouped together in an outer bag. Th e box quantities are packed in a cardboard box with two polyethylene liners. See safespeccleanroom.dupont.co.uk for the exact packaging confi guration details.

1

2 3b

43a