Typical Project Features:
- Containment down to 1 nanogram/cubic meter
- US FDA / EU Regulatory Compliance
- Development and Commercial Scale Operations
- Flexible, Multi-Product Operations
- Isolators
- Closed Transfer Systems
- Bag Systems
- CIP Systems
- Decontamination Systems
- Airlock / Pressurization Schemes
- Dust Collection
- Segregated Systems
- Waste Collection / Treatment Systems
- Process Utility Systems
- HVAC Systems
- Automated Production
- Cleanroom Spaces
- Gowning / Locker Rooms
- Emergency Back-up / Redundant Systems
Potent Compound Overview:
CE&IC is recognized as a leader in the planning and design of processes and facilities handling highly potent compounds. We’ve had the opportunity of working with our clients on a wide range of containment related projects supporting API, oral solid dosage, sterile fill/finish, and biologic projects. These projects have ranged from developmental pilot scale operations through large scale commercial production. Some of these projects have involved retrofits within existing processes/facilities and others have involved new stand-alone facilities.
We can assist our clients in delivering their Potent Compound containment projects from feasibility studies and concept development through detailed design, construction assistance and commissioning. We have worked with our clients to implement a wide range of approaches/technologies to achieve their containment goals. The containment strategy often depends upon the level of containment required and can include technologies such as isolators, closed transfer systems, CIP systems, downflow booths, dust collectors, bag systems, airlocks, decontamination showers, waste collection, etc. CE&IC has been highly effective in working with our clients over the past 35+ years to successfully implement potent compound containment for numerous projects in the less than 1 to 10 micrograms per cubic meter range along with containment to as low as 1 nanogram.
Following is a listing of some typical containment strategies/technologies where CE&IC has previous experience:
- Isolators
- Closed Transfers Systems
- Closed Conveying Systems
- Dust Collection
- Airlock / Pressurization Schemes
- CIP Systems
- Equipment Wash Stations
- Decontamination Systems