Keystone Safety and Cleanroom Products, a leader in pharmaceutical sterilization wrapping solutions, is proud to announce the expansion of its production facilities with the construction of more ISO 6 cleanroom capacity and purchase of an additional 115,000 sq.ft warehouse. Keystone Cleanroom Products are proudly manufactured in Pennsauken, NJ, USA within certified ISO 6 and ISO 8 cleanrooms utilizing advanced equipment, materials, and processes. The expansion comes from increased demand because of new requirements enforced by EU GMP Annex 1 in the steam sterilization of pharmaceutical change parts.
Meeting the New EU GMP Annex 1 Standards
In 2024, Keystone Safety and Cleanroom Products launched the PureClean™ line of autoclave bags and covers as a solution for aseptic manufacturing operations to meet the new requirements by EU GMP Annex 1. The PureClean™ line is made with 1421B Tyvek®, which is next-generation Tyvek® from DuPont™ manufactured without an anti-stat agent applied to it, which had been found to cause residues left behind post-sterilization.
Some other features of Keystone's PureClean™ line include:
- Ability to "right-size" bags in use: Keystone Cleanroom Products offers a wide range of sizes to ensure a perfect fit for every application.
- Hermetically sealed closures: Keystone Cleanroom Products provides autoclave bags with both heat-seal and self-seal closures, eliminating the challenges posed by the drawstring closures found in larger Tyvek bags. These drawstring closures often make it difficult to fully dry the folds and creases of the twisted "gooseneck" design.
- Clear Film Side for Visual Inspection: Keystone Cleanroom Products' PureClean™ Self-Sealing 1421B Tyvek® Autoclave bag with Clear Film Side and Steam Indicator has a clear film side that allows for easy visual inspection without breaking the sterile barrier, as required by Annex 1.
EU GMP Annex 1 calls for aseptic manufacturers to maintain a robust Contamination Control Strategy (CCS), with a particular focus on supply chain stability. Supplier management, inventory reliability, and sourcing strategy all play a role in maintaining consistent contamination control. Keystone Cleanroom Products supports this approach with U.S.-made cleanroom products, stable inventory, reliable product availability, and diversified supply options to help reduce risk without disrupting operations. The new expansion of Keystone Safety and Cleanroom Products will allow for continued supply chain stability to best support the Contamination Control Strategies of our aseptic manufacturing customers.
Keystone Safety and Cleanroom Products' Commitment to Innovation and Quality
Keystone Cleanroom Products stands apart from the competition by operating in certified ISO 6 and ISO 8 cleanrooms through the entire manufacturing process. The rolled good raw materials are introduced to the cleanroom by dedicated material transfer rooms, where the external protective wraps are removed, before the raw material can enter the ISO 8 spreading and cutting cleanrooms. A fully automated material-spreading process, followed by a Computer-Aided Design (CAD) cutting system ensures precision and reduces operator variability. This minimizes operator interaction with the raw material and eliminates the variability of outputs, compared to when patterns are used, with an operator leaning over the raw materials and cutting it with an electric knife, in a non-cleanroom environment, which is exactly what Keystone's competitors do. However, Keystone Cleanroom Products believes in the importance of starting with clean raw materials and using only the most advanced manufacturing equipment, materials and processes to ensure the quality products that our demanding customers deserve and expect. Keystone Cleanroom Products also offers a full line of validated sterile (10⁻⁶ SAL) disposable products that complement our wide range of sterilization wrapping products.
Availability and Further Information
Keystone Safety and Cleanroom Products' line of PureClean™ 1421B Tyvek® bags and covers are available for purchase. If you are interested in receiving samples and more information, please visit our website at www.keystonecrp.com.
About Keystone Safety and Cleanroom Products
Keystone Safety and Cleanroom Products, originally founded as Keystone Adjustable Cap in 1925, revolutionized the food service industry with the introduction of the first disposable protective paper cap. Today, we are known as a trusted leader in disposable protective apparel, offering the most comprehensive range of product solutions, across multiple industries. In 2018, we launched our Cleanroom Products division to provide customers with everything related to pharmaceutical sterilization packaging and innovative, pre-sterilized disposable products for use in aseptic production. To keep your operation in compliance, we provide expert consultation and continuous support from the start of a project, all the way through validation. We design and manufacture our products in Pennsauken, NJ USA and are subject to routine GMP audits and inspections by our end user customers.
