Bio-Decontamination Of Isolators

A barrier isolator, or simply an isolator, is a device that provides a physical barrier between a laboratory technician and a work process.

Isolators are routinely found within the pharmaceutical industry, and with the recent implementation of USP 797 and other similar regulatory standards around the world, are increasingly used in pharmacy applications.

They are designed to provide an isolation of a process or the maintenance of an internal condition (e.g., sterile or aseptic). Isolators may operate at positive, negative, or ambient differential pressure.

Isolators may provide personnel, product, or environmental protection, or any combination thereof. They are used throughout industry, from orange juice filling lines to cytotoxic drug compounding to electronics manufacturing.

Regarding pharmacy applications, because people are the greatest source of contamination during aseptic manufacturing of drugs, reducing personnel interventions into the process zone has significant impact on the efficacy of the final drug product.

The scientific process and high level 6-log sporicidal efficacy of the Bioquell hydrogen peroxide vapour (HPV) decontamination process makes it ideal for Isolator decontamination applications.

Supported by proven validation rationale and documented GMP/cGMP compliance optimised cycles can be developed across different scales of process application.

From a range of Bioquell HPV generators, using direct injection techniques for optimised control, applications may include

• Sterility / Bioburden testing
• Compounding
• Aseptic transfers (loading/unload Freeze Dyers, Autoclaves), aseptic assembly of medical devices and Aseptic Fill-finishing.

Decontamination processes are fully automated with integrated gas distribution and control. Together with one of Bioquell's Rapid decontamination transfer solutions fully optimised cycle times can be achieved leading to reduced downtime and improved process efficiency.