Table 1 Sampling Plan for Real Time Aging Study of Cellentra VCBM Minimum

Table 1 sampling plan for real time aging study of

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Table 1. Sampling Plan for Real Time Aging Study of Cellentra VCBM Minimum Sample Quantity Time Pts LAL (TM-079) Cyto (TM-083) Viability (TM-088) Osteogenic ¥ (TM-089) OI Visual/Leak (RCS-118 & TM-062) Burst (ICIQAP192) Box & Label Cellentra (2cc) Cellentra (5cc) Cancellous (5cc) Cancellous (5cc) DBM (1cc) Simulated Simulated Empty Box Baseline * Covered in PQ-399 Covered in PQ-406 1yr 3 3 3 3 3 10 5 18 months 3 3 3 3 3 10 3 yrs 3 3 3 3 3 10 5 yrs 3 3 3 3 3 10 Total qty 12 12 12 12 12 40 5 Note: * Product and packaging performance for base line are covered in PQ-399 and PQ-406, respectively. † Non destructive test. Samples will be visually inspected at the end of each time point. ¥ Cancellous sample tested for viability (TM-088) can be used for osteogenic assay (TM-089).
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Title: Shelf Life Study for Cellentra Viable Cell Bone Matrix (VCBM) for Up to 5 years PQ Protocol # 423 Page 5 of 8 6 MATERIALS AND EQUIPMENTS 6.1 Test samples: See Table 1 for minimum sample quantity, type and volume. 6.1.1 Cellentra VCBM Cat. No. STM-001, STM005, STM010 and/or STM015, double bagged and labeled. 6.1.2 Cancellous tissues 6.1.3 DBM 6.1.4 Simulated sample: largest size of Cellentra VCBM using (sterile) water. 6.2 Equipments 6.2.1 So Low Upright Freezers set at – 70 °C or lower, Asset # MF-493, MF-541, or equivalent 6.3 Materials and Equipments per appropriate test methods and procedures 6.3.1 Pouch Integrity Test: TM-062 6.3.2 Creep-to-Burst Test: ICIQAP192 6.3.3 Cell Count and Viability: TM-088 6.3.4 Osteogenic Assay: TM-089 6.3.5 LAL Assay: TM-018 or TM-079 6.3.6 Cytotoxicity: TM-083 7 VALIDATION PROCEDURE 7.1 Test Sample Preparation : 7.1.1 TBI will manufacture at least three (3) lots of Cellentra VCBM. Refer to table 1 for minimum sample quantity for 4 studied time points. 7.1.1.1 Cellentra VCBM: 28 cc/lot 7.1.1.2 Cancellous: 40 cc/lot 7.1.1.3 DBM: 4 cc/lot 7.1.1.4 Simulated VCAT: 40 samples of largest size 7.1.2 Packaging shall be performed by qualified personnel following validated sealing procedure. 7.1.3 Samples will be packaged in vials, double bagged and labeled. 7.1.4 TBI will send the double pouched samples to Biomet Interpore Cross in TBI dry ice shipper(s).
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Title: Shelf Life Study for Cellentra Viable Cell Bone Matrix (VCBM) for Up to 5 years PQ Protocol # 423 Page 6 of 8 7.1.5 Biomet Interpore Cross Quality will qualify the donor per RCS-118. 7.1.6 Store double pouched samples and at least five (5) labeled box at – 70 °C or colder temperature for this study. 7.1.7 Perform or coordinate for testing at the end of each aging period. 7.1.8 Prior to product performance testing, samples should be thawed per instructions given in the Package Insert, LD64-1000, or as instructed in the specified test method. 7.2 Stability of Packaging System : 7.2.1 Visual Inspection: Conduct visual inspection for all samples. Detect any damage to Cellentra VCBM packaging system including pouch and box label integrity. Refer to RCS-118 for inspection criteria for packaging configuration. 7.2.2 Pouch Integrity: Conduct Leak test on outer pouches and inner pouches of aged samples per TM-062.
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  • Fall '09
  • Zynda
  • Test method, Cortical bone, Cellentra Viable Cell

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