Show Menu

A fully integrated developer and manufacturer of ovine polyclonal therapeutics, targeting infectious disease and acute toxic events

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.

Environment

  • 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.

Equipment

  • 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. 

Applications

  • Liquid filling of vials. 
  • Batch volumes 10-20L. Fill volumes up to 10 mL routinely, larger by arrangement.