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Cleaning Validation

PharmaSys has extensive experience in developing and executing cleaning validation programs in multi-product facilities.  We understand the challenges of ensuring a consistent and effective cleaning program in high throughput facilities.

Cleaning validation ensures that specific cleaning processes consistently clean residuals to pre-defined limits of acceptability (product or cleaning chemistry related) based on a scientifically based methodology.  A good cleaning validation program will provide documented evidence that residuals from previous processing and cleaning do not adulterate and adversely affect the safety and quality of the next product manufactured.

Our highly skilled team can help your organization ensure that equipment cleaning procedures are removing residues to pre-defined levels of acceptability. We can deliver a complete package from development and execution of engineering studies and protocols, to creation of cleaning matrices, swab rationales, cleaning procedures, equipment cleaning and use logs, and training documentation.

Machinery in a Physics Lab
  • Solid Dose

  • Ointments, Creams, Liquids

  • Parenterals

  • Biotech Processes

  • Packaging Components



Complete understanding of FDA requirements, guidelines and expectations. Selection and evaluation of effective cleaning methods and processes. Establishment of residue limits and calculation sample acceptance criteria. Selection of sampling and analytical methods.

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