Contract Manufacturing and Sterile Filling
This service is offered to the pharmaceutical industry on a contract basis. Our facilities are particularly suited to the smaller batch size and, filling in either ampoules or vials.
- 147 sq.m Class 100,000 (EU Grade D) clean rooms divided into four main processing rooms.
- Isolators to provide localised Class 100 (EU Grade A) filling environment.
- Environmental monitoring (viable and non viable) ensures compliance.
- UKMHRA authorisation for GMP compliant manufacture and filling of products for use in humans (contact us for further details)
- All equipment is of GMP compliant design.
- Validated filling facility comprising La Calhène custom isolator, Rota liquid filling machine and Steris vaporised hydrogen peroxide (VHP) generator.
- Envair isolator for manual filling of small batches.
- Lytzen type CB sterilisation / depyrogenation oven
- Four Class 100 (EU Grade A) laminar flow units giving localised high specification areas within the clean room environment.
Quality Assurance and Documentation
- Full traceability.
- Customer audits welcomed.
- All SOPs and validation documents available for review.
- Liquid filling of vials.
- Batch volumes 10-20L. Fill volumes up to 10 mL routinely, larger by arrangement.