Location: Bedford, OH
Area: N/A
Project Cost: Confidential
Share:
This client is a multinational oncology contract manufacturer. Their production was ceased at the instruction of US-FDA to reflect further changes to the Validation Approach or to the scope of the equipment, facility, or utilities.
PharmEng provided various services to restart production for four manufacturing facilities at the client’s site, which supported multiple lines. The services that we provided made certain that the client’s processes and equipment complied with FDA requirements and include:
- Site Validation Master Plan Development
- Equipment Validation
- Autoclaves
- Hot Air Ovens
- Freezer Dryers
- Vial Washers
- Parts Washers
- Stopper Washers
- Depyrogenation Tunnels
- LFI Clean Air Carts
- Formulation Tanks
- Packaging Lines
- Clean Steam Generator
- Cleaning Effectiveness Studies
- HVAC System Qualification for the cleanroom complexes
Responsibilities:
- Site Remediation for FDA Consent Decree
- HVAC Commissioning & Qualification
- Validation Master Plan
- Process Validation
- Cleaning Validation
- Equipment Validation
- SOP Development
Ben Venue Laboratories
Location:
Bedford, OH
Area:
N/A
Project Cost:
Confidential
Bio-containment level:
Share:
