Should Acces to Cleanrooms be Controlled?
Access Control to cleanrooms is important for several factors. These include Contamination Control:
Only trained, authorized personnel should enter cleanrooms to minimize the risk of introducing particulates, microbes, or other contaminants. Compliance and Traceability: Regulatory bodies (like FDA and EU GMP) expect strict control over who accesses critical areas. Access logs support investigations and audits. Zonal Integrity: Cleanrooms are often classified (Grade A to D). Access control helps maintain pressure differentials and prevents cross-contamination between zones. Security: Prevents tampering, sabotage, or theft of sensitive materials or equipment — especially important in high-value or highly regulated drug manufacturing. Integration with Monitoring Systems: Access events can be integrated with EMS or Building Management Systems to correlate environmental changes (like a pressure drop) with personnel movement.
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