Producers of polyclonal antibodies for therapy, diagnosis and research








CONTRACT SERVICES

 

CONTRACT MANUFACTURE AND FILLING

This service is offered to the pharmaceutical industry on a contract basis. Our facilities are particularly suited to the smaller batch size, 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.

FREEZE DRYING

MicroPharm can offer a filling and freeze-drying service to the diagnostics industryand academia. We have long experience in the manufacture and packaging of diagnostic kits and will be pleased to discuss your requirements.

 

  
Ampoule opening
  
Ampoule opening
  
  

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.
  • Freeze drying in vials or in bulk containers.

Sample of Vials

  
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