Validation

Axis Consulting 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, allows us to expedite the generation of key validation protocols.

Axis Consulting 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.

Facilities

• Fill and Finish
• 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, International shipping qualifications

Utilities

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

Cleaning Sterilization Equipment

• Autoclaves
• CIP & SIP
• Glassware Washers
• Depyrogenation Ovens
• VHP Sterilizers

Controlled Temperature Units

• Incubators
• Controlled Temperature Units including Freezers, Refrigerators and Cold Rooms
• Cryoshippers