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.
What the bundle covers
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.
Standards addressed
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.
Make it specific to your process
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 documentation documents; qualification depends on your approved study and results.
