Turnkey Sealer Validation

ISO11607 Part 2 requires that sterile barrier packaging processes, including forming & sealing, be validated through a three-step process: 1) Installation Qualification, 2) Operational Qualification, and 3) Performance Qualification.  Let our engineers assist you in managing this effort from start to finish.  We will author all of the relevant protocols, visit your facility to execute the validation work, train your employees in the appropriate procedures, coordinate and perform the relevant sterile barrier testing, and issue reports and work instructions.   


Who Turnkey Sealer Validation is for

Medical device manufacturers purchasing new sterile packaging equipment or are in the process of validating a new packaging system.

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What's Included in Turnkey Sealer Validation

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Authorship of protocols

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Memorandum of seal characterization and range finding memo

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Detailed work instructions for equipment and packaging

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On-site client training

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IQ/OQ/PQ validation reports

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