4-Side Seal Pouch Qualification Protocol Bundle
Plan operational and performance qualification together with the A.P. Lyon 4-Side Seal Pouch Qualification Protocol Bundle. Use the paired documents to document the proposed operating window and evaluate repeatable production performance for four-side pouch sealing 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.
Four-side pouch sealing OQ and PQ
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.
Using a different sealing configuration? See the separate Bar Sealer Qualification Protocol Bundle for bar sealing or Tray Sealer Qualification Protocol Bundle for tray sealing. Select the protocols that match your equipment and package design.
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 Four-Side Seal Pouch Qualification: Sealing Window and Production Evidence for workflow guidance, a checklist and common mistakes.
