The isolator unit under construction, showing the frame, base tray and Steritest Equinox pump
Pharminox Isolation (Cambridge) in the UK has received an order for the design, construction, installation and validation of a sterility testing isolator for a global pharmaceutical company. This is a major contract and represents a significant addition to the company’s client portfolio.
The client has elected to use flexible film construction for this isolator, with operation via a half-suit. The isolator, measuring approximately 2x1.5m, has a Millipore “Equinox” pump incorporated into the base tray. A Steris M100 hydrogen peroxide vapour generator is built into the support frame and this is directly connected to the isolator ventilation system. An ATI “Iso-Mon” hydrogen peroxide meter is also fitted into the ventilation system, giving direct readings of both high (0 to 2,000ppm) and low (0 to 20ppm) levels of VPHP. The control system maintains isolator air flow and pressure, and provides alarms on both parameters, but avoids the need for a PLC and the complications that this involves. The simple loading door has a pneumatic seal that ensures leak-free operation, while carefully designed minimum-contact racks and shelves present the isolator load for maximum exposure during sporicidal gassing.
The engineering consultancy has increased turnover steadily since its inception in 1995, and founding director, Caroline Coles, expects growth to continue, despite the current economic climate.
Coles said: “We are a very small and flexible organisation, able to move quickly in response to client demand, a key factor in our success. This combined with our very low overheads, allows us to compete successfully with larger organisations.”