A Guide to Smarter Autoclave Bagging with PureClean™ Tyvek® Self-Seal Closure Bags
The Problem with Drawstring Tyvek® Bags
Are You Still Using Outdated Autoclave Packaging?
Twenty years ago, most aseptic pharmaceutical plants were still operating with conventional filling lines. Companies were using oversized Tyvek® drawstring bags as an "outer" bag for heavy filling machine parts like stopper bowls, hoppers, and tracks. To avoid cutting cellulose based Bioshield paper and autoclave tape in the Grade A space and generating particles, companies were using oversized drawstring bags to sterilize these parts.
In 2025, isolators and RABs are now commonplace. The large, outer autoclave bags don't need to be, nor could effectively be, opened in Grade A as they will be opened in Grade B for RABs and Grade C for isolator technologies. The bigger concern for organizations today is ensuring that the autoclaved parts are clean from a particulate standpoint, rendered sterile, dry, and free from any residues.
Issues with Traditional Drawstring Closure Bags
The drawstring closure design of larger, Tyvek® bags makes it extremely difficult to get the folds and creases of the twisted "gooseneck" closure completely dry. It is likely that there will be condensate present inside the bag, regardless of how long the autoclave drying cycle is extended. This phenomenon can be exacerbated by the oversized drawstring bag design. The excessive amount of hydrophobic material traps the steam in its gaseous state and allows it to condense into water droplets. When unwrapping, this residual moisture (anti-stat agent in solution) could be dispersed throughout the bag and transferred onto equipment parts. In addition, the tortuous path closure can be difficult to defend to an outside auditor or regulatory authority, especially if autoclaved parts are not unloaded and allowed to cool under Grade A LAF before being moved into Grade B/C storage prior to use.
- Incomplete drying of folds and twisted closures
- Difficulties with inspections and/or audits
- Risk of moisture or anti-stat residue transferring to sterile parts
- Inconsistencies in wrapping technique between shifts/locations
Introducing PureClean™ 1421B Tyvek®
Keystone Cleanroom Products' Solution to Smarter Autoclave Bagging
Keystone Cleanroom Products' solution is a holistic approach at modernizing autoclave wrapping. Our PureClean™ 1421B line of autoclave bags were designed with the new EU Annex 1 guidelines in mind.
No Anti-Stat Agent Applied
PureClean™ 1421B Tyvek® is the next generation of Tyvek®, manufactured without an anti-stat agent applied.
Right-Sizing Bags In Use
Keystone Cleanroom Products offers a wide variety of sizes, for the perfect fit, every time.
Hermetically Sealed Closures
Self-Sealing closures provide consistency and ensure moisture won't be trapped in folds.
Clear Film Side
The clear film side allows for easy visual inspection of dryness, as required by EU Annex 1.
The Smart Switch
Match Your Sterilization Wrapping to Today's Cleanroom Demands
Let Us Help You Make the Switch to the Next Generation of Sterilization Wrapping.
