Effective cleaning is essential to protect patient safety, and cleaning processes must be proven to remove active pharmaceutical ingredient residues, cleaning materials, and any microbial contamination to a pre-determined level. This is a GMP requirement that will be fully inspected by the relevant regulatory authorities. Cleaning validation is a critical aspect of quality control, and necessary for ensuring your product is fit for release. 

We can support you with cleaning validation, both for due diligence and troubleshooting issues.  We offer a unique ‘best practice’ cleaning validation consultancy package.  Using our expertise in manufacturing, analytical and microbiological, our cleaning validation team will visit your plant, and work through a step-wise process to evaluate/design the requisite aspects, ensuring that solid foundations are in place for the successful execution of your cleaning validation.  

Our cleaning validation services will:

  • Test and challenge your cleaning regime 
  • Demonstrate compliance with GMP requirements 
  • Allow you to manufacture with confidence 
  • Facilitate process improvements and productivity gains 
  • Equip your staff to implement better hygiene 

Cleaning Validation Analysis

Our expert scientists conduct microbiological and chemical analysis of swabs, purge and rinse waters to support you with cleaning validation and due diligence, and reflect the expectation of current GMP guidelines. We use a number of detection techniques that may be coupled to chromatographic analysis. Mass spectrometry may also be necessitated to achieve greater sensitivity for particularly low detection limits. 

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Training and Consultancy

We also provide consultancy and training to support your cleaning validation processes.  

Our practical one-day cleaning validation training course provides professionals responsible for the design, execution and validation of cleaning processes with a thorough grounding in process design and pitfalls to avoid, along with understanding of fundamental issues in the area.

Cleaning Validation Services

Validation of cleaning procedures

  • Chemical Analysis

    RSSL provides a wide range of GMP chemical analyses supporting quality control testing in accordance with pharmacopoeial monographs and client methods.

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Testing the efficacy of your disinfectants

Interpretation of the results

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