The excellence of our free services is reached through an interdisciplinary teamwork among engineers and technicians having a unique integrated know-how in process engineering, information technology and quality in regulated environment.
Due to our complete in house instruments park, we can provide the solutions for process equipment and utilities qualification based on the latest technologies, regulatory requirements and focused to minimize compliance related risks and costs.
URS/Qualification/Validations protocols writing, reviewing, finalizing of FAT and execution (Installation, Operational and Performance Qualification)
- Validation Master Plan
- Commissioning Plan
- Cleaning Validation
- Process Validation
- Media Fill Protocols
- Calibration services
- Witnessing of Supplier Testing activities (FAT/SAT support)
- Inventory of Process Equipment and Utilities
- Quality Risk Management
- User Requirement Specification
- Technology Transfer
- Process Analytical Technology (PAT) Support
- Clean Room qualification
- Warehouses & Cold chambers temperature mapping
We have extensive knowledge on the Qualification of the following systems:
- Systems for Sterile Forms Facilities
- Filling Lines for Ampoules
- Filling Lines for Vials
- Filling Lines for Cartridges
- Filling Lines for Syringes
- Filling Lines for pouches
- Blow Seal lines
- Autoclaves
- Vials-Cartridges-Ampoules Washing Machines
- Isolators
- Glove Boxes
- Crimping Machines
- Vials Inspection Machines
- Ampoules Inspection Machines
- Secondary Packaging Equipment's
- Dispensing Systems
- Systems for Oral Forms Facilities
- Granulators
- Tablet Pressing Machines
- Coating Machines
- Blistering Machines
- Fluid Bed Driers
- Bin to Bin Stations
- Tumblers
- Powder Conveyor Systems
- Sachet Filling Systems
- Bin Washing Stations
- Dispensing Systems
- Isolators
- Glove Boxes
- Bottles Filling Lines
- Secondary Packaging Equipment's
- Dispensing Systems
- Systems for Topics and Ointments Facilities
- Tube Filling Lines
- Secondary Packaging Equipment's
- Holding Time Validation for Tanks Storage's
- Dispensing Systems
- Emulsion Systems
- QC Laboratory Systems
- Incubators
- Stability Chambers
- Fridges
- Autoclaves
- Washing machines
- Utilities
- Water Systems (WFI, PW)
- Pure Steam Systems
- Room qualification Process Gases (Compressed Air, Nitrogen, Propane etc)
- Compressed Air Systems
- HVAC systems
- Laminar Flow Systems
- Bio-hazard Hoods
- Continuous Particles Monitoring Systems
- BMS/SCADA
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