A Pouch or Tray Seal Integrity Testing 48 TPTR 0982 Packaging Performance

A pouch or tray seal integrity testing 48 tptr 0982

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TM-062, Rev. A, Pouch or Tray Seal Integrity Testing 4.8 TP/TR-0982, Packaging Performance Verification for Amcor Pouches 5. RESPONSIBILITY 5.1. Zimmer Biomet Interpore Cross Quality is responsible for: 5.1.1. Receiving and inspecting the Amcor pouches to ensure the materials meet Amcor specifications for new materials. 5.1.2. Coordinating with Manufacturing for preparing test articles.
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Title: Sealing validation of Amcor CFP-005 Chevron Peel Pouches using Doboy Band Sealer, Asset #450 PQ Protocol # 436 Page 5 of 7 5.1.3. Conducting in-house testing Pouch integrity and peel test: TM-062 Seal Strength: ICIQAP192 5.1.4. Preparing validation report. 5.2. Zimmer Biomet Interpore Cross Manufacturing is responsible for sealing new pouches. 6. MATERIALS AND EQUIPMENTS 6.1. Test samples: 6.1.1. See Table 3 for minimum sample quantity required for testing. 6.1.2. C1-2558 Pouches 6.1.3. 40cc Bone Graft Syringes: P1-3202-3, P1-3203-3 or simulated syringes 6.2. Equipments 6.2.1. Doboy Heat Sealer, Asset # 450 6.3. Materials and Equipments per appropriate test methods 6.3.1. Pouch Integrity Test: TM-062 6.3.2. Creep-to-Burst Test: ICIQAP192 7. PRE-VALIDATION ACTIVITIES 7.1. Verify that the new pouches meet manufacturers/suppliers specification. Table 3. Sampling Plan Sealer Pouch Sealing Minimum Sample Quantity Parameter Seal Integrity* Asset # Dimension and PN Setting Visual/ Leak (TM-062) Bust (ICIQAP192) Peel Test Doboy #450 Lowest 30 10 10.00” x 16.50” (C1-2558) Highest 30 10 Nominal 30 10 Note: * Each sample will be tested for Visual and Leak prior to Burst.
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Title: Sealing validation of Amcor CFP-005 Chevron Peel Pouches using Doboy Band Sealer, Asset #450 PQ Protocol # 436 Page 6 of 7 7.2. Verify that the sealers are within calibration. 7.3. Verify that Manufacturing personnel who prepare samples for this study have been trained for appropriate procedures. 7.4. Verify that test analyst(s) have been trained for relevant procedures. 8. VALIDATION PROCEDURE 8.1. Test Sample Preparation : 8.1.1. Refer to Table 3 for minimal sample quantity of each test group. Each pouch contains five (5) P1-3203-3 syringes or simulated syringes to represent worst case scenario. 8.1.2. Sealing of the pouches shall be performed by qualified personnel following instructions in ICIM402, Rev. B. Doboy sealer parameters: Low: Temperature: 265 °F Pressure: 36 psig Conveyer Speed: 280 inches/min High: Temperature: 285 °F Pressure: 44 psig Conveyer Speed: 240 inches/min Nominal: Temperature: 275 °F Pressure: 40 psig Conveyer Speed: 260 inches/min 8.1.3. Perform seal integrity and seal strength tests per following sections.
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  • Fall '09
  • Zynda
  • Pinniped, Doboy Band Sealer

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