Contained Operations Overview
PCI is able to demonstrate a long and successful track record in the development and manufacture of products requiring containment resources.
Our facilities and capability for handling potent products enables the safe development, clinical and commercial supply of products with an OEL as low as 0.01μg/m3 (eight hour time weighted average).
Key attributes of our contained manufacturing service include:
- Capability to process multiple compounds
- Development scale to commercial scale batch sizes
- Segregated people and material flows
- Secure access and client viewing gallery
- Automated cleaning procedures
- Contained engineering solutions eliminating the need for PPE
- HVAC system with single pass air
- Temperature and humidity controlled processing areas
- Small and large-scale packaging options
- Meeting global regulatory standards including the MHRA, FDA, ANVISA, Turkish Ministry of Health and Japan
- Purpose-built high performance bespoke effluent treatment facility
- Design-for-manufacture delivering true speed-to-market