STERILE WORK
Sterile production is undertaken in the accredited aseptic manufacturing suite operating at a range of environments up to grade ‘B’ EU GMP standards. The sterile unit operates two Envair CDC-‘F’ 2G2D grade ‘A’ negatively pressured isolators for safe aseptic reconstitution, manufacture, manipulation and dispensing of cytotoxic drugs. This facility also has integrated mounted IP CCTV cameras in separate grade ‘B’ aseptic rooms.
Specifications of the facility includes:
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Integrated HVAC air conditioning and filtration system controlling temperature and humidity maintaining more than 20 air changes per hour in higher graded rooms with a pressure cascade that provides at least 10-15 pascals differentials between adjacent rooms of different grades
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EU GMP grade 'A' (unidirectional airflow) work area
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High air change rate 'D' type transfer chambers with electromagnetic timed interlocks
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All areas accessible for cleaning
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PLC controls for easy setup, operation and maintenance
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User friendly automatic pressure decay leak test
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Pharmagraph environmental monitoring system recording particle measurements in isolators and aseptic rooms, as well as temperature and humidity levels throughout the Manufacturing Suite and Production Store Room
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Environment monitored using TSA settle and contact plates weekly and SDA settle and contact plates monthly
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Temperature monitoring of all fridges and freezers
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Secure access with door interlocking system
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Intercom system between manufacturing environments