BIOVET VACCINE MANUFACTORING

BIOVET VACCINE MANUFACTORING

Biovet JSC has made a decision ("Development Project") to investment in veterinary vaccines in order to develop its product portfolio. For this purpose, it is planned to produce different types of vaccines for poultry, ruminants and pigs in his own settlement in Razgrad.

Inactivated and live vaccines will be produced for poultries, ruminants and pigs in this facility. These vaccines may be viral, bacterial or combinations of them. İn addition, common manufacturing areas, warehouse, quality control areas, formulation and filling areas, experimental animal houses, utilities areas, cell labs, seed labs, washing area, media preparation labs and social areas will be projected.

The physical containment level used when working with live microorganisms in laboratories shall be at least the appropriate level for the risk group of the microorganism, as set out in EU guidelines and WHO Laboratory Biosafety Manual Requirements for laboratory BSL-1, BSL-2 and BSL-3 containment facilities.

Guidelines and Regulatory Requirements:

EU cGMP Guidelines; ISO 14644; WHO Laboratory biosafety manual; 2010/63/EU "DIRECTIVE on the protection of animals used for scientific purposes“; 9CFR; EU Pharmacopeia; The Rules Governing Medicinal Products in the European Union ; Guide to Good Manufacturing Practice for Medicinal Products; Regulatory Basics for Facility Design; Hygiene according to DIN 1946-4 – Standard for hygienic AHU; Guideline - Hygiene according to DIN 1946-4; Duct Leakage test; Risk Analysis for HVAC system

Mechanical system elements summary – more than 500 labs with BSL-1, BSL-2 or BSL-3:

89 hygiene Air Handling Units with over a 1 000 000 m³/h condition air; Cooling Capacity – over 7 000 kW; Heating Capacity – over 5 000 kW; Steam Capacity – over 4 000 kg; More than 1 500 Variable Air Volume Dampers wits 2 seconds reaction; More than 3 000 Air Terminals including Supply Hepa Filters; More than 15 000 m with 25 000 m² ductwork

Electrical system elements summary:

Total installed power – 10 MVA; Electrical switchboards - more than 110 pcs.; Low voltage cables - more than 110 000 m Cable trays - more than 15 000 m; Process control information cables - more than 200 000 m; Fiber-optic cables – 22 000 m; Light fixtures for clean rooms – 4 100 pcs.; Light fixtures outside clean areas – 1 800 pcs.; Cable ducts in clean rooms – 15 000 m; Communication cabinets (RACK) – 25 pcs.