Bar Sealer Qualification Protocol Bundle
Plan operational and performance qualification together with the A.P. Lyon Bar Sealer Qualification Protocol Bundle. Use the paired documents to document the proposed operating window and evaluate repeatable production performance for bar sealing of pouches of medical-device sterile-barrier packaging.
Included: two editable Microsoft Word (.docx) protocols—one Operational Qualification (OQ) and one Performance Qualification (PQ)—supplied together in a ZIP file as a digital download.
Pouch sealing OQ and PQ document scope
OQ: prerequisite checks and challenges at the upper and lower limits of the proposed operating window.
PQ: at least three production runs, process monitoring and assessment of within-run variation and between-run reproducibility.
Packaging and process risk records, product-family justification and verification links.
Test setup and observation records for seal strength, visual inspection and applicable dye penetration.
Sample traceability, results, deviations and review/approval documentation.
The included protocols reference EN 868-5, ISO 13485:2016 and FDA QMSR (21 CFR Part 820), alongside ISO 11607-1:2019 and ISO 11607-2:2019.
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. These are editable documents; qualification depends on your approved study and results.
The revised documents address 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.
Choose the protocol for your sealing equipment. For tray sealing, see the separate Tray Sealer Qualification Protocol Bundle; for four-side pouch sealing, see the separate 4-Side Seal Pouch Qualification Protocol Bundle. This bar sealer bundle contains its own OQ and PQ protocols only.
Individual documents in this 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 Bar Sealer Qualification: Planning Pouch OQ and PQ for workflow guidance, a checklist and common mistakes.
