This flexible, user-friendly system reduces the risk of cross contamination and shields operators from exposure to harmful compounds when handling APIs during filter change-out procedures
Protecting workers and the surrounding environment from exposure to hazardous compounds poses an increasing challenge to pharmaceutical manufacturers as new and more potent active pharmaceutical ingredients (APIs) enter the processing pipeline, such as cytotoxic (cell killing) drugs to treat cancer.
Separation and purification processes potentially expose workers to harmful, biologically active, contaminating particulates and catalysts filtered from the APIs.
To help remedy the problem, Pall is introducing the GBK Containment System which provides the pharmaceutical industry with its first all-in-one contained glove bag /housing system for filter change-out.
The flexible, user-friendly system reduces the risk of cross contamination and shields operators from exposure to harmful compounds when handling APIs during filter change-out procedures.
Operators can easily access replacement filters from zippered feed-in sleeves and then remove spent filter cartridges through a feed-out sleeve using nitrile gloves.
The user-friendly system enables trained operators to perform a complete filter cartridge change-out in less than two minutes on average.
Currently about 5-10% percent of commercially available drugs are high potency.
With more potent and targeted drug molecules under development, this figure increases to about 25% and is the fastest growing segment of small-molecule custom synthesis.
The increased need for new and enhanced containment solutions is also driven by the growing investment of both major pharmaceutical companies and small biotech firms in the anticancer area.
"This global trend is a serious concern for drug manufacturers which need to set new occupational exposure limits (OELs) into their operations," says reports Gareth Leach, global API market manager for Pall Life Sciences.
"The introduction of our GBK containment system provides an innovative, compact and cost-efficient solution to help meet this critical industry need." The GBK System provides a convenient alternative to glove boxes and other bulky isolation systems that can require more costly capital expense and more manufacturing floor space.
GBK glove bags are made of antistatic polyurethane with a built-in Hepa filter to prevent condensation.
They are available with double zippered feed-in sleeves for maximum operational flexibility and feature an elastic ring that ensures an effective seal to the housing to prevent airborne particles from escaping.
GBK gloves bags are also available with sealed sleeves for more critical applications where additional protection is needed.
The GBK system can be used for multiple steps in a production process.
After a batch or campaign is completed, plastic bags and gloves can be easily discarded.
For multi-purpose manufacturing sites, the GBK system also protects from cross-contamination between different systems that might otherwise be susceptible to airborne contamination.
Independent tests with a worst-case containment challenge show that the GBK system could be used to provide a containment level to 1mg/m3.
The Pall PATK series housings incorporated in the GBK containment system offer a robust design for secure locking code seven cartridges, ideal for API applications.
For each installation, Pall specialists will provide technical support and user training.
The GBK system is the latest addition to Pall's extensive line of filtration and processing innovations.
As a total solutions provider to the pharmaceutical marketplace aligned to customer needs, Pall's technologies help improve drug-processing safety, efficiency and speed time-to-market of new therapies.
