Don Whitley Scientific launches a range of workstations specifically designed for use in Good Manufacturing Practice (GMP) certified facilities that require strict anaerobic or oxygen-controlled conditions.
The isolators combine sterile laminar airflow with either anaerobic conditions or physiologically relevant conditions, providing better than Grade A air cleanliness (EU GMP) and ISO 14644-1 Class 3 both at rest and in operation. They make use of physical isolation and positive operating pressure to maximise sample protection.
The compact, completely closed, re-circulating isolator systems can be housed in a Grade D Cleanroom during GMP compliant use, which is more cost-efficient than creating a full cascade system. Users can create their own bespoke system by configuring multiple workstations to create a modular GMP Processing Suite, complete with areas for high-risk processing, incubation, or refrigeration. Three-way airlocks are available to 'join' the workstations and enable samples and equipment to be transferred between units and the laboratory without compromising internal conditions.
Full validation packages and a range of possible decontamination protocols, including the use of vaporised hydrogen peroxide, are available on all GMP systems. Possible applications for an A Range station include faecal microbiota transplant, probiotics manufacture, bacteria manufacture, live biotherapeutics, biopharmaceuticals, and microbiome therapeutics. The H range GMP is suitable for ATMP manufacturing, regenerative therapies, and CAR T-cell immunotherapies.