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.
What's Included in Turnkey Sealer Validation
Authorship of protocols
Memorandum of seal characterization and range finding memo
Detailed work instructions for equipment and packaging
On-site client training
IQ/OQ/PQ validation reports