Product/Service
NEWFORM™ Cleansteam™ Sterilization Bags
Source: ATMI LifeSciencesDatasheet: NEWFORM™ Cleansteam™ Sterilization Bags
Ultraclean Steam Sterilization Packaging
Contamination is a factor when particles are released from opening sterile packages. Medical environments need to be sterile and the packaging particle and contaminant-free.
Newform™ Cleansteam™ and Easy-Tear Cleansteam™ bags are designed to fulfill the most stringent requirements in the sterilization process of critical components and have out-standing performance in terms of cleanliness, material and seal strength, as well as microbial barrier properties.
Cleansteam sterilization bags are compatible with a variety of sterilization methods, such as Steam and ETO sterilization. The bags are made from breathable, medical grade Tyvek® and in-house extruded medical grade HDPE.
Striving to meet the need for ultraclean, sterile packaging, ATMI LifeSciences has developed the Newform™ Cleansteam® Bag using DuPont's FDA-approved uncoated Tyvek® combined with HDPE. Tyvek has demonstrated an inherent ability to withstand microbial penetration and maintain sterility after repeated test. When bonded with HDPE, the result is a low linting, microbial barrier package that has virtually no airborne particles.
Cleansteam™ Sterilization Bag Applications
- Stoppers
- Vials
- Syringe components
- Medical devices
- Process equipment parts
Benefits
- PE film is free of black points and gels
- Faster sterilization cycling time due to the use of uncoated Tyvek®
- Less EtO absorption than ordinary paper packaging
- 100% recyclable product
- Higher performance over paper and non-clean Tyvek which can lead to particle and molecular contamination
Features
- Choice of standard or Easy-Tear opening
- Cleansteam Easy-Tear Bags offer easy manipulation and opening without using knives or other cutting devices
- HDPE segment on Easy-Tear Bag allows for easier heat-sealing
- HDPE film extruded in a controlled environment. Bag is produced in an ISO Class 7 environment and ultraclean to level 200 (according to IEST-STD-CC1246D)
- Materials comply with FDA regulations
- Allows for steam, EtO and gamma sterilization processes
- Superior seal and burst strength
- Steam sterilization indicator printed on each bag
- Low bioburden levels
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Datasheet: NEWFORM™ Cleansteam™ Sterilization Bags

