Tray Sealer Performance Qualification Protocol

Use the A.P. Lyon Tray Sealer Performance Qualification (PQ) Protocol to evaluate repeatable sealing performance under defined production conditions for medical-device sterile-barrier packaging. The editable format provides a structured starting point for tray sealing.

Included: one editable Microsoft Word (.docx) protocol, supplied in a ZIP file as a digital download.

What the protocol covers

• 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.

Standards addressed

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.

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. This is a documentation document; qualification depends on your approved study and results.