Performance validation of a novel laminar flow anaerobic workstation

Good manufacturing practice (GMP) is crucial for ensuring the safety, quality, and efficacy of pharmaceutical, food and other regulated products. Adhering to GMP guidelines helps prevent contamination, errors and product failures, safeguarding consumer health and trust. It establishes standardised processes, documentation, and quality control measures, promoting consistency and reliability throughout the manufacturing chain.

In recent years, the increase in the manufacturing of live biotherapeutic products under GMP regulations has stimulated development of the Whitley A135 GMP Workstation. This workstation is a novel device and is unique in comparison to other pharmaceutical isolators or Class II Microbiological Safety Cabinets (MSCs). The A135 GMP combines the sterility of unidirectional laminar airflow with an oxygen-free atmosphere, provided by circulating anaerobic gas, within an entirely closed system. Together with positive operating pressure, the workstation can achieve physical isolation of samples within the workspace and provide EU GMP Grade A air cleanliness. The custom-made HEPA filter achieves ISO Class 3 particle counts, whilst most MSCs can only claim ISO Class 5 particle counts. 

BS EN 12469:2000 is a standard that outlines the performance criteria for MSCs used in the field of microbiology and biotechnology.¹ The standard establishes requirements for the design, construction and performance of microbiological safety cabinets to ensure the correct handling of samples and the maintenance of environmental integrity. The standard outline requirements are for: airflow and containment, construction, HEPA filters and ventilation, safety features and testing, and certification. By adhering to the requirements outlined, workspace and sample handling can be protected from particulate and microbial contamination which compromises quality assurance.