Dr David Phillips, senior global product technology specialist , clean air at Thermo Fisher Scientific looks at how the adoption of advanced Class II BSCs in cGMP environments is helping to deliver safe and effective medicines.
Cleanliness
Pharmaceutical manufacturers have a responsibility to consistently deliver safe and effective medicines, and this can be achieved by complying with the Food and Drug Administration’s (FDA) current Good Manufacturing Practice (cGMP) regulations. To meet the stringent cleanliness and containment requirements set out in the regulations, manufacturers largely rely on Class II Biological Safety Cabinets (BSCs). However, until now, regular monitoring of air cleanliness and quality within cabinets has been a key challenge. The latest advances in Class II BSCs address this issue and these systems can be easily integrated into facilities, enabling manufacturers to fully comply with cGMP standards and deliver high-quality, safe products.
A need for Good Manufacturing Practices
cGMP-regulated environments are essential for the manufacture of drugs, ensuring a clean and safe setting with no risk of contamination. Indeed, poor cGMP conditions at a manufacturing facility could ultimately pose a life-threatening health risk to a patient. As such, the manufacture of sterile products is subject to special requirements as set out in the FDA’s cGMP standards and EU Guidelines for Good Manufacturing Practice. Quality Assurance is a particularly important aspect of these regulations, and pharmaceutical manufacturers must strictly follow carefully established and validated methods of drug preparation and manufacturing procedure to comply and ensure product safety.