Validation
DPM provides comprehensive validation lifecycle services from risk/impact assessment to validation master planning, protocol generation, hands-on execution through to final release for use.
We develop protocols from user requirements, functional specifications and design specs to provide a transparent, traceable validation package. Additionally, we make extensive use of our validation library and matrix tools that employ the most appropriate protocol templates for your system requirements. This, combined with our own experiences, allow us expedite the generation of key validation protocols.
DPM has written and executed Process Validation protocols to support the commercialization of novel products as well as Comparability protocols to validate changes to licensed processes.
DPM are active contributors to the Validation community. We are regular industry speakers and have been fortunate to present annually at numerous conferences. We actively develop and contribute to industry working groups to harmonize Validation policies and practices across the field.
Facilities
- Fill and Finish
- API Manufacturing
- Oral Solid Dosage
- Laboratories
Process Equipment
- Cell Banking: Liquid Nitrogen storage
- Pre-Culture: Stirrer flasks and small scale fermenters
- Inoculum Fermentation: Small scale fermenters
- Production Fermentation: Large scale bioreactors
- Technical Services: Media and buffer preparation
- Clarification and Concentration: Centrifuges, Homogenizers, Ultrafiltration and Diafiltration
- Purification: Chromatography Skids
- Fill and Finish: Lyophilizers, Filling Machines, Oversealers
- Inspection: Automatic and Semi-Automatic Inspection machines
- Labeling and Packaging: Labellers, Cartoners
- Shipping: Temperature control and stability
Utilities
- HVAC
- Water for Injection
- Purified Water
- Clean Steam
- Process Gases: Clean Dry Air, CO2, N2 and O2
- Process Vacuum
- Glycol
Cleaning Sterilization Equipment
- Autoclaves
- CIP
- Glassware Washers
- Depyrogenation Ovens
Controlled Temperature Units
- Incubators
- Controlled Temperature Units including Freezers, Refrigerators and Cold Rooms
- Biosafety Cabinets
- Laminar Airflow Units
Automation
- Building Automation Systems
- SCADA
- Equipment Controller Upgrades
- Computerized System Validation and Part 11 Compliance
- Vision systems