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•Datasheet: NEWFORM™ Ultraclean Sterilizable Flexible Packaging

Ultrapure Medical Grade Polyethylene Packaging

Any step of the manufacturing process can introduce contamination which can affect the purity of the product. An ultraclean way to package medical devices, pharmaceutical ingredients and other devices for sterilization by gamma irradiation is the Newform™ Medical Grade Bag. These bags are composed of a pure, pinhole-free, medical grade polyethylene film produced by ATMI LifeSciences.

The Gamma Sterilization Bag is the ideal packaging solution for sterilization by gamma irradiation (25 kGy) and by request can be delivered gamma-irradiated prior to shipment.

Applications

• Intravenous solutions
• Filters
• Active pharmaceutical ingredients
• Medical components
• Sensitive medical devices

Benefits

• Material DMF-file registered with US FDA (DMF file 8124)
• LDPE film is free of black points and gels
• Certificate of sterilization delivered with every shipment
• Conforms to European pharmacopoeia (3.1.3 and 3.1.4)
• Conforms to US Pharmacopoeia <88> Biological Reactivity Tests, In-Vitro, Plastic Class VI

Features

• Low particle level: cleanliness levels of bags available from level 50 to visible clean (according to IEST-STD-CC1246D)
• Sterilizable by gamma-irradiation (25 kGy)
• Pinhole-free medical grade PE film extruded in a controlled environment. Bag is produced in a ISO Class 7 environment
• Puncture resistant PE
• Low bioburden levels

Click Here To Download:
•Datasheet: NEWFORM™ Ultraclean Sterilizable Flexible Packaging

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