Cleaning Validation Services
In pharmaceutical and biomedical applications, cross-contamination between products can compromise patient safety, halt production, cause batch failures, and result in FDA rejection – leading to costly fines. Cleaning validation is essential in verifying that cross-contamination does not occur, particularly between components used in the pharmaceutical process, chemical deposits, and microbes. Regularly performing cleaning validation is essential in pharmaceutical production, particularly in verifying the effectiveness of contamination prevention.
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Relying on a partner to conduct an initial qualification of your manufacturing process and equipment is an ideal starting point. Through the NEXA CQV Cleaning Validation Services, our team will manage your cleaning validation to effectively equip you in preventing contamination by:
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Clearly defining products
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Establishing acceptable limits
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Providing testing support
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Performing post-implementation reporting
Our team will ensure that standard operating procedures (SOPs) are developed for the cleaning processes of utilized equipment; written procedures are created to specify the responsibilities for performing and approving the validation study, as well as the criteria for acceptance and the circumstances under which re-validation will be necessary; documented protocols are created for inspecting each piece of equipment; and reporting is prepared to determine validity of the cleaning process.
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To view a case study detailing our Cleaning Validation Remediation for a pharmaceutical company, click here.
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Contact our team for a consultation to discuss your Cleaning Validation needs.