HYPER is intended for use in the pharmaceutical and radio-pharmaceutical industries, with the purpose of guaranteeing aseptic processes, for example aseptic transfer of materials and tools, handling and production of drugs, and performance of sterility testing.
Processes are validated using biological indicators Geobacillus stearothermophilus to consistently achieve a 6-log sporicidal reduction. HYPER works in single pass (open loop) configuration to achieve fast biodecontamination cycles. It is controlled by a Siemens PLC S7 Series to ensure a safe control process and generate a complete bio-decontamination cycle report. HYPER can be either integrated within the isolator structure or externally located. To eliminate operators’ exposure to the liquid hydrogen peroxide during handling of bulk product, HYPER uses specifically designed disposable containers of 35% Hydrogen Peroxide (H2O2).
Applications
Typical applications: Aseptic Productions, Sterility Testing, Quality Control operations.
Compliances
Annex 1, EU Guidelines, cGMP, GAMP 5, FDA CFR 21 part 11.
