82 Seal Integrity Test 821 Visual Inspection Conduct visual inspection for all

82 seal integrity test 821 visual inspection conduct

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Perform seal integrity and seal strength tests per following sections. 8.2. Seal Integrity Test: 8.2.1. Visual Inspection: Conduct visual inspection for all samples. Detect any damage to pouch integrity. 8.2.2. Pouch Integrity: Conduct Leak test on the pouches of each test group per TM-062. 8.2.3. Peel Test: Conduct peel test per TM-062.
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Title: Sealing validation of Amcor CFP-005 Chevron Peel Pouches using Doboy Band Sealer, Asset #450 PQ Protocol # 436 Page 7 of 7 8.3. Seal Strength Test: 8.3.1. Seal Strength (Creep-to-Burst Test): Calculate minimum burst pressures and perform Creep-to-Burst test per ICIQAP192 for burst samples. 8.4. Review data and complete a report. 9. ACCEPTANCE CRITERIA 9.1. Any deviations from this protocol occurring during execution of this validation shall be noted in the report and an evaluation whether the deviation(s) affects the validity and/or integrity of the validation. 9.2. Packaging Integrity: Sealed pouches shall meet the requirements of TM- 062. 9.2.1. The sealed pouches shall show no signs of holes, burns, folds, voids, or any seal irregularity in the sealed area. 9.2.2. Sealed pouches shall not form one or more bubbles in ten (10) seconds when tested at 0.5 psig. 9.2.3. Sealed pouches shall be opened with easy to moderate difficulty. 9.3. Seal Strength: The sealed pouches must pass all testing upon execution of Creep-to-Burst test per ICIQAP192. 9.3.1. Measured burst pressure of sealed pouches shall not be less than minimum burst pressure (P min ). 9.3.2. Process Capability Index (CpK) ≥ 1.33. 10.APPENDIX 10.1. Appendix 1: Amcor Validation Reports: Protocol #1336, Rev. Orig. and C 10.2. Appendix 2: Drawings 10.2.1. C1-2558, Rev. B, Chevon Peel Pouch 10.2.2. P1-32003-5, Rev. C, Five-Pack Bone Graft Syringe
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  • Fall '09
  • Zynda
  • Pinniped, Doboy Band Sealer

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