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CCS: Common Mistakes Made by Emerging Biotechs

A contamination control strategy is not a document created for inspection. It should be the visible expression of how an organisation prevents contamination through facility design, process control, behaviour and governance.

Common mistakes

  • Treating the CCS as a static document rather than an operating strategy.
  • Failing to integrate engineering controls, HVAC, utilities and cleanroom design.
  • Over-relying on environmental monitoring as if detection is the same as prevention.
  • Underestimating personnel behaviour as a contamination risk.
  • Failing to define ownership, governance and periodic review.

What good looks like

A useful CCS links hazards, controls, monitoring, procedural expectations and governance in a way that operators, engineers, QA and leadership can all understand and apply.

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