Tray Sealer Performance Qualification Protocol
Assess repeatable tray sealing under defined production conditions with this editable performance qualification (PQ) protocol for medical device sterile-barrier packaging. It guides production-run monitoring, within-run and between-run results, seal tests, deviations and approval.
Included: one editable Microsoft Word (.docx) protocol, supplied in a ZIP file as a digital download.
Tray sealing production performance qualification
Prerequisites and nominal operating conditions established through operational qualification.
At least three production runs, with assessment of within-run variation and between-run reproducibility.
Process monitoring, product-family justification and links to packaging and process risk controls.
Test setup and observation records for seal strength, visual inspection and applicable dye penetration.
Sample traceability, results, deviations and review/approval documentation.
Before execution, customize and approve the equipment, materials, product-family coverage, process limits, sampling rationale, laboratory methods and acceptance criteria. Example quantities and limits require justification for your application. This is an editable document; qualification depends on your approved study and results.
The revised document addresses ISO 11607-1:2019 and ISO 11607-2:2019, each with Amendment 1:2023. Applicable test sections address ASTM F88/F88M-23 seal strength, ASTM F1886/F1886M-25 visual inspection and ASTM F1929-23 dye penetration for suitable porous/transparent seal constructions.
The revised protocol also references EN 868-5, ISO 13485:2016 and FDA QMSR (21 CFR Part 820).
Establish and challenge the process limits first with the Tray Sealer Operational Qualification (OQ) Protocol. Both protocols are included in the Tray Sealer Qualification Protocol Bundle.
Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.
Practical guide
Read Tray Sealer Qualification: OQ vs PQ for Sterile-Barrier Packaging for workflow guidance, a checklist and common mistakes.
