Human Biologicals Institute; a division of IIL engaged in human vaccine production has two manufacturing facilities; one at Ooty, Tamilnadu, and the other one at Hyderabad, Telangana, India.
Manufacturing facility at Ooty
Manufacturing facility at Ooty, Tamilnadu produces Rabies vaccine using Vero cell line as a substrate for human use.
The Human Biologicals Institute at Ooty is located at Kozhipannai village approximately five Km from Ooty town. This facility contains Production labs, Quality control lab, Warehouse, Animal testing facility and Utilities block. The design and construction of the plant meets Schedule M and cGMP guidelines.
The production area is classified into unrestricted and restricted area.
Unrestricted Area contains Cell culture laboratory, Media production lab, Purification lab and Formulation & filling, Packing and Manufacturing services. No live virus is handled in the unrestricted area. This area is designed as per the GMP with the provision of change rooms and equipped with HVAC for the maintenance of the class and differential air pressure etc.
The restricted area contains Virus seed production lab, Antigen production, Concentration and inactivation, in- process quality control and Manufacturing Services. The entire restricted area is maintained under negative pressure and differential air pressure maintained through HVAC system. This area is designed to meet the biohazard containment as per the WHO guidelines .The effluent generated from these areas is decontaminated by a unique heat based treatment plant located at the basement with negative pressure. The effluent from the restricted area is collected and sterilized by a steam-based treatment Plant at 121°C for 30 minutes prior to release for conventional treatment.
Manufacturing facility at Hyderabad
Manufacturing facility at Hyderabad is engaged in production of DPT, DT,TT and Hepatitis B vaccine. Human Biologicals Institute (HBI) has dedicated production blocks for the manufacture of bacterial antigens, formulation & filling. In total, there are nine blocks which includes eight production blocks and one utility block.
1. B-1 – Formulation & Filling Block
2. B-2 – Toxoid purification Block
3. B-3 – Diphtheria Antigen Production Block;
4. B-4 – Pertussis Antigen Production Block;
5. B-5 – Formulation & Filling Block
6. B-6 – Hepatitis B
7. B-7 – Services Block
8. B-8 – Tetanus Antigen Production Block;
9. B-9 – JE & Chikungunya Antigen Production Block
The manufacturing facilities are designed and constructed in compliance with schedule M and cGMP guidelines for men and materials movement and process flow requirements. The manufacturing facilities are provided with adequate clean room Heating, Ventilation and Air Conditioning (HVAC) system to maintain required temperature and relative humidity and different grades of clean rooms.
All manufacturing blocks have dedicated utilities like water system and pure steam system.
Cold Chain Maintenance & Delivery:
HBI maintains a robust cold chain system of storing and transporting vaccines at the recommended temperature range from the point of manufacture to the point of use. In order to provide potent and effective vaccine to the beneficiaries a vast cold chain infrastructure is maintained by IIL, which includes a network of vaccine stores, Walk-In-Coolers (WIC), Walk-In-Freezers (WIF), Deep Freezers (DF), Ice Lined Refrigerators (ILR), Refrigerator Trucks, Vaccine Vans, Cold Boxes, Vaccine Carriers and Ice Packs.
The vaccines are transported from the manufacturing plant to the vaccine stores through air transport under the temperature range of 2º-8ºC. HBI is having a fool proof validated CCMD system in place which is 100% efficient and effective in maintaining the required temperature till the vaccine is delivered to the patient.