Equipment and process support
Equipment and process validation.
MCS specializes in medical-packaging heat-sealer validation and can also support qualification and validation of other equipment and processes used in your production operations.
What MCS does
Qualify the equipment. Validate the process.
Your project may involve qualifying equipment, such as a heat sealer or UV chamber, or validating a specific process, such as sealing a particular pouch on a heat sealer.
MCS helps define the scope, develops and executes the protocols, and prepares the reports for your quality management system (QMS). For process validation, equipment validation is confirmed first, and the DOE results inform the OQ/PQ protocol.
Nationwide validation support
Validation at MCS. Support nationwide.
MCS supports customers nationwide with validation work performed at the MCS facility. For heat-sealer projects, customers can send their equipment and the pouches used in production. MCS develops and executes the agreed validation protocols and provides completed protocols and reports for retention in your quality management system (QMS).
- Sealer flexibilityWork with heat sealers from any manufacturer.
- Statistically justified testingMCS develops sampling plans based on production risk and agreed acceptance criteria, then seals and tests the quantities required by the validation protocol.
- Package testingTesting includes seal-strength testing per ASTM F88/F88M, seal-width measurement, visual inspection, and leak testing using ASTM F1929 dye penetration or ASTM F2096 bubble testing, as appropriate for the pouch construction and validation requirements.
- Documentation for your QMSMCS provides completed validation protocols and reports for your review and retention in your quality management system (QMS).
Equipment validation
Installation qualification, through the final report.
For equipment such as a UV chamber or heat sealer, MCS develops and executes the IQ protocol and documents the results.
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Develop the IQ protocol
MCS develops an Installation Qualification (IQ) protocol that includes equipment functionality.
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Execute the IQ protocol
MCS executes the protocol for the equipment being qualified.
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Prepare the IQ report
MCS prepares an Installation Qualification report for retention in your quality management system (QMS).
Process validation
From process parameters to documented OQ/PQ results.
For a process such as sealing a specific pouch, the DOE establishes the basis for the OQ/PQ protocol.
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Confirm equipment validation is complete
MCS confirms that equipment validation is completed before proceeding with process validation.
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Develop and execute the DOE
MCS develops and executes a Design of Experiments (DOE) to evaluate the different process parameters.
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Document the DOE results
MCS generates a DOE report for retention in your QMS.
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Develop the OQ/PQ protocol
MCS uses the DOE results to develop the Operational Qualification and Performance Qualification (OQ/PQ) protocol.
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Execute the OQ/PQ protocol
MCS executes the protocol for the specific process being validated.
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Prepare the OQ/PQ report
MCS generates an OQ/PQ report for retention in your QMS.
Start a conversation
Tell us about your validation project.
Whether you need equipment qualification, process validation, or both, we’ll work with you to clarify the scope and next steps.
Prefer to call or email? (952) 649-8293 mncleanroomservices@gmail.com