Delta PM provides comprehensive validation consulting services throughout the whole lifecycle, starting from risk and impact assessment, validation master planning, and protocol generation, to hands-on execution through to final use release.

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. Combining this with our own experiences allows us expedite the generation of key validation protocols.


CLEANING STERILIZATION EQUIPMENT
Validation


PROCESS EQUIPMENT
Validation

 

 

 

 



 

Controlled Temperature Units / Temp Mapping

 

FACILITIES

  • Autoclaves
  • CIP
  • Glassware Washers
  • Depyrogenation Ovens
     
  • 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
     
  • Incubators
  • Controlled Temperature Units including Freezers, Refrigerators and Cold Rooms
  • Biosafety Cabinets
  • Laminar Airflow Units
     
  • Fill and Finish
  • API Manufacturing
  • Oral Solid Dosage
  • Laboratories

UTILITIES

  • HVAC
  • Water for Injection
  • Purified Water
  • Clean Steam
  • Process Gases: Clean Dry Air, CO2, N2 and O2
  • Process Vacuum
  • Glycol

automation

  • Building Automation Systems
  • SCADA
  • Equipment Controller Upgrades
  • Computerized System Validation and Part 11 Compliance
  • Vision systems