Validation Services

Preliminary Validation Planning     Critical Utility Qualification
Validation Master Plan Development   Equipment Qualification
Protocol Development and Execution IQ,OQ,PQ   Analytical Equipment Qualification
SOP Development     Facility Qualification
Final Report Development     Cleaning Validation
Retrospective Validation     Process Validation

 

Commissioning Support

Site Acceptance Testing   Factory Acceptance Testing
Vendor Auditing   System walkdowns and punch list generation
Summary Report Development    
Equipment and Systems Experience


Equipment:

- Reactors
- Incubators
- Crystallisers
- Inspection Systems
- Hydrogenators
- Lyopholizers
- Dryers
- Cell Culture Bio reactors
- Centrifuges
- IBC Blenders
- Fluid Bed Dryers
- IBC Wash Stations
- Freezers
- Mixers
- Cappers
- Ovens
- Depyrogenation Tunnels
- Refrigerators
- Encapsulators
- Storage Chambers
- High Intensity Granulators
- High Speed Tablet Presses
- Vessels
- Filtration Systems (MF, UF, TFF)
- Tunnels
- Glassware Washers
- Fermenters
- Glove Boxes
- Fillers
- Fume Hoods
- Compendial Water Systems
- Clean Steam Generators
- Critical Gas Systems
- Fixed and Mobile Sanitary Process Vessels

Utility Systems:

- Compendial Water Systems (Purified Water USP/EP, WFI USP/EP)
- Non Compendial Water Systems (DI, Ro, UF)
- Vacuum Systems
- HVAC Systems
- Clean Steam Systems
- Chilled & Potable Water Systems
- Clean Compressed Air Systems

 
 

 

Concentric BioPharmaceutical Services Inc.

Home Temperature Mapping Validation Services Events Links Contact Us