Bar Sealer Operational Qualification Protocol
Use the A.P. Lyon Bar Sealer Operational Qualification (OQ) Protocol to plan and document challenges to the proposed sealing process limits for medical-device sterile-barrier packaging. The editable format provides a structured starting point for bar sealing of pouches.
Included: one editable Microsoft Word (.docx) protocol, supplied in a ZIP file as a digital download.
What the protocol covers
Prerequisite checks for installation qualification, calibration, procedures and personnel training.
Risk-management records linking packaging and process controls to verification evidence.
Challenges at the upper and lower limits of the proposed operating window, with a documented rationale.
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.
