Comecer’s new modular isolator system is specifically conveived for lab professionals who require aseptic conditions for sterility testing of pharmaceutical products
Comecer’s new Modular Isolator System meets the ever-changing needs of customers by ensuring future expansions and upgrades are easy to make.
Specifically conceived for lab professionals who require aseptic conditions for sterility testing of pharmaceutical products, the level of aseptic conditions achievable with the system, means other processes such as Aseptic Dispensing/Sampling, and Aseptic
Product Transfer can also be conducted using the system.
The system is truly modular. The standard version is composed of a class A testing chamber and a class B pre-chamber (grade B before sterilisation – grade A after sterlilisation). Once installed in this configuration, it can be upgraded and expanded as needed with further modules such as additional chambers, rapid tansfer ports, sterility testing systems, viable and non-viable counting systems, and wide variety of sensors.
Designed for the sterility testing of pharmaceutical products, the base isolator system is composed of one class A, four-glove chamber and one class B pre-chamber. The pre-chamber may be used as a rapid gassing port.
The system is equipped with a unidirectional air-flow for both chambers with positive pressure with respect to the lab environment. It is designed to take air from a Class D laboratory or from a HVAC system. It uses HEPA (H14) unidirectional down flow filters and return filters and Inlet pre-filtration is available on request. Pressure chamber and inlet/outlet filters are constantly monitored.
Made of high-grade stainless steel 316L internally and 304 externally, all the unit’s inflatable and static seals are made of FDA approved White Silicon Bio-Guardian. This elastomer contains anti bacterial inhibitors to prevent surface growth of micro organisms. All the view panels are made of 12 mm tempered glass and may be externally laminated with a safety film. The unit comes with an adjustable operator stool.
The system is controlled via a user-friendly operator touch panel and uses GAMP 5 compliant software.