Sterile Veterinary Vaccine Production

Features

• Expansion of a 2,100 m2 existing facility to produce sterile injectible fish vaccine to European GMP’s
• Facility includes process areas for seed preparation, fermentation, inactivation, blending, emulsification, sterile filling and packaging
• Provision for in-process control and quality laboratories, with provision of future space for downstream processing and support services, utilities and HVAC
• All areas where live organisms may be present are contained to the Health and Safety Executives (HSE) Advisory Committee on Genetic Manipulation (ACGM) Large Scale Containment Category (LSCC) 1
• Consulted with the Veterinary Medicines Directorate (VMD) of the Ministry of Agriculture, Fisheries and Foods (MAFF) to ensure that the proposals complied with cGMP regulations and guidelines
• Initial site selection exercise carried out
• Clean rooms of Class C and D, handling of live organisms within isolators
• Detailed process and piping design for all areas including steam sterilisable pipe systems
• Kill tank system designed for biowaste decontamination with steam