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Sources of contamination in a Biopharmaceutical environment and the…
Sources of contamination in a Biopharmaceutical environment and the identification of improved control measures.
Facility Design: Aseptic process rooms, Air Filtration and air change, Temperature, Airlocks, RABs, Air pressure and Ventilation, HVAC
Building Requirements: Interior surfaces, windows & viewing panels, pipe work, sinks and plumbing.
Utilities: Water used in manufacturing should be suitable
for its intended use (pharmaceutical grade, microbiologically controlled and monitored).
Access to Areas: unauthorised personnel in high risk areas (production areas, packaging and QC). Personnel should only have acces to authorised areas from changing rooms. Material transfer via air locks.
Personnel: Access to production, hygiene, roles, training in GMP, Protective attire, contact with API and how it should be prevented.
Cleaning & Disinfection: Areas must be regularly cleaned and disinfected in conforming to SOPs and GMP practice. Grades of disinfectants must be known and applied correctly. Contact time, application, temperature of storage, mechanical action and chemistry of agents must be known.
Regulatory guidance, Standards and Risk Assessments.
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The use of risk assessment tools to determine the most appropriate methods for environmental monitoring.
Tools include;
1)Constructing flow charts and diagrams.
2)Pinpointing ares of greatest risk.
3)Examining potential sources of contamination.
4)Deciding on the most appropriate sample methods. 5)Helping to establish alert and action levels .
5)Taking into account changes to the work process and activities.
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ISO
Clean room classification standards FS 209E, ISO 14644-1 and the British standard 5295.
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