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Key Takeaways:
- Cleaning and disinfection should be based on scientific rationale.
- Cleaning before disinfection is widely accepted but not always mandatory.
- High-residue areas require a distinct cleaning step to ensure disinfectant efficacy.
- Manufacturers should use a risk-based, process-specific strategy over rigid guidance.
Regulatory guidance and standards, such as the European Good Manufacturing Practice (EU GMP) Annex 1, are created to provide standards for requirements. While this can be helpful to strive toward best-practice, it is also important to remember that procedures need to be tailored to their facilities and processes. In this article, STERIS Technical Expert Walid El Azab addresses the scientific approach to determining if a separate cleaning step is needed before disinfection.
