Completed Validations and Sub-Validations
 

1. QCRV – Quality Control Release Verification
   1. WFI –water for irrigation lines
   2. Power Plant
      1. Holding Tank
      2. Sterilizers
      3. Still
      4. Compressed Air
      5. Steam and Condensate return lines
      6. Co-gens
   3. Clean Room repairs and upgrades
2. PTRA – Production Test Run Authorization
   1. Conveyor PLC change and proximity switch installation
   2. New Inkjet Printer Installation
   3. Boxing equipment change and installation
3. Process
   1. Compounding
      1. Antibody
      2. Microparticle
      3. Wash buffer
   2. Filling Precision and Accuracy
   3. Pouch Fabrication
   4. Bag Fabrication
   5. Bottle injection molding design specifications
4. Equipment
   1. Manufacturing
      1. Bag washers and rinsers
      2. Washing machines
      3. Fillers
      4. Component Washers and Driers
      5. Injection molding machines
      6. Film extrude
      7. 2 Laser Titanium Welders
      8. Gamma Counter and auxiliary equipment
      9. Seed (Source) Assembly Machine
      10. Multi-Channel Analyzer System and auxiliary equipment
      11. Seedburo Seed Counter
      12. Capintec Gamma Dose Calibrator Machine
      13. Brachytherapy source Heat Stress Equipment
      14. Blow Molders
      15. Labeling and printing machines
      16. Boxing and ink dispensers
      17. Conveyors and associated mechanisms
      18. Ultrasonic welders
      19. Component assembly machines
      20. Hoods
      21. Stills
      22. Filters (including integrity tests)
      23. Homogenizer
      24. Steam, compressed air and WFI lines
      25. Facility
      26. Beta Press Tableting Machine.
      27. Nordenmatic semi-solid filling machine.
      28. Compounding Homogenizing 2,500 liter Tanks
   2. Lab
      1. FPLC
      2. Refrigerators
      3. Freezers
      4. Incubators
      5. Spectrophotometers (Waters)
      6. Purified and Deionized water
      7. Bag parallel and cylindrical burst pressure testers
      8. Plunger activation machine
      9. Test fixture for Opthalmic laser subassemblies
5. Cleaning
   1. Compounding Equipment (see Qualisys Task Highlights)
   2. Facility Sanitation
6. Sterilization
   1. Sterilization Tank Validation assistance
      1. Viable and non viable testing
      2. Pressure and Filter Integrity
      3. Fo Limits - Steam, EtO
      4. BI testing
7. PLC
   1. Allen Bradley RSLogix 500
   2. Capping machine PLC change (BB)
   3. Bag fabrication Machine (BB) *
      1. Alarms challenge
      2. Parameter challenge
      3. Proximity switches
      4. Temperature sensors
      5. Environmental Controls
      6. Robotics
      7. Custom built Laser Welding Mach. (U)
      8. Seedburo seed counter, titanium welder
8. V&V (software and hardware)
   1. FastPack Analyzer
      1. FTA (fault tree analysis)
      2. FMEA (failure mode and Error analysis)
      3. Software Validation assistance
9. Test Method Validation
   1. QC methods
      1. QC method for raw components dimensional testing.
      2. QC method for sampling of voltage, resistance, capacitance on raw components.
      3. QC test method for biotin binding capacity.
      4. QC test method for protein purity.
      5. QC test method luminescent reagent purity.
      6. QC test method raw material purity on reagents and components.
      7. QC test method using FPLC for assay.
10. Facility Audits and Validations
    1. Power plant
       1. Boiler room
       2. WFI
       3. Compressed air
       4. Steam &  Condensate Return
       5. Co-gens & Chillers
    2. HVAC and Air Systems
    3. Clean Rooms (class 100K to 1K)
       1. Main manufacturing facilities
       2. Gowning Rooms
       3. Airlocks
       4. Transfer Rooms
          1. HEPA filtration and integrity
          2. Room air change
          3. Viable and non-viable air
          4. Viable surface
          5. Smoke studies
          6. Positive Pressure
          7. Personnel PM and viable tests.
11. Software Validations (Part 11)
    1. AssurX – Verification of a Customized SQL based dBase for NCMR, Audit, issues tracking system (with over 1,000 items)
    2. Equipment and Documentation Control System - Access dBase
    3. BlueMountain Calibration Management System
    4. MFG-Pro ERP system report modules.
    5. LabView laser system
    6. SolidWorks Viewer
    7. Excel Templates
    8. Backup/Archive System