11Processing and packaging options

PACKAGING OPTIONS

STERILE PACKAGING PROCESS FOR OPTION DS Th e garment is individually packed in a dual barrier validated packaging system, consisting of an inner and outer easy tear, validated, cleanroom bag. Th e box quantities are packed in a cardboard box with two polyethylene liners.

PROCESSING AND PACKAGING OPTIONS

PROCESSING OPTIONS

CLEAN-PROCESSED AND STERILE Clean-processed and sterile garments (option code MS, DS or CS): Garments are specially processed to minimize particle shedding, then folded to aid in aseptic donning and packed in an ISO Class 4 cleanroom. Th e box quantity is packed in a cardboard box with two polyethylene liners. Sterility is achieved by gamma irradiation. Radiation dosage is validated in accordance with ISO 11137 for a Sterility Assurance Level (SAL) of 10 6.

STERILE Sterile (option code 0S): Garments are folded to aid aseptic donning and individually packaged. Th e box quantity is packaged in a cardboard box with two polyethylene

liners. Some sterile items are folded and individually packaged in an ISO Class 5 cleanroom. Sterility is achieved by gamma irradiation. Irradiation dosage is validated in accordance with ISO 11137 for a sterility assurance level (SAL) of 10 6.

NON-STERILE Bulk (option code 0B,00 or BH): Box quantities are packed in a cardboard box with two polyethylene liners. IsoClean® garments are individually packed, with one polyethylene liner in the cardboard box. Note: Individual packaging for sleeves, shoe and boot covers indicates that each pair has its own sealed bag. Masks may have subgroupings of individually packed items within the case.

1. Outer shipping box is securely sealed. Carton displays product label, sterile dot indicator and fully traceable lot 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 and allows transportation of product to a cleaner, more controlled environment.

3. (3a and 3b) Each garment is 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 garment consistently folded and packed to ease aseptic donning. Traceable lot numbers are stamped on each individual sterile garment.

1

2 3b

43a