GMP Extraction Cleanrooms

SO…WHAT DOES GMP COMPLIANCE REALLY MEAN IN TERMS OF A CLEANROOM FACILITY? 

• Routinely monitored environmental conditions – particle monitoring system with alarm if limits are exceeded (grade B) as well as temperature, humidity, and pressure differential monitoring.
• Clean area entry through airlocks for personnel and/or equipment/materials (pass-through)
• Clean areas maintained to the appropriate cleanliness standard
• Air supplied passed through filters of appropriate efficiency
• Component preparation, product preparation, and filling carried out in separate areas
• Microbiological monitoring
• All exposed surfaces should be smooth, impervious, and unbroken to minimize the shedding or accumulation of particles or micro-organisms and to permit repeated application of cleaning agents and disinfectants
• No uncleanable recesses and a minimum of projecting ledges, shelves, cupboards, and equipment
• Doors should be designed to avoid uncleanable recesses
• Sinks and drains prohibited in grade A and B for aseptic filling
• Both airlock doors must not be opened at the same time and use interlocking system or visual/audible warning system to prevent this from happening
• Demonstrate airflow patterns do not present a contamination risk
• Ambient temperature and humidity should not be uncomfortably high for employees