Facility
Facilities

Incepta Vaccine Ltd is now manufacturing a number of vaccines at Zirabo, Savar. It is an independent, self-sufficient unit with its own dedicated technical manpower and utilities.

The plant is located about 35 Km north of Dhaka City and covers over 3.5 acres land in non-polluting clean surroundings. In this area, a complete separate modern facility building has been developed as per cGMP guidelines and global regulatory requirement in respect to Biological and Vaccines. The total built up production facility is about 100,000 square feet. The plant consists of a general purpose manufacturing building, a specialized modern microbiology laboratory and a high tech quality control laboratory. A separate area houses the Research & Development facility and Antigen bulk facility that can independently handle several projects simultaneously involving bacteria and virus. A cGMP compliant Animal house is also at this site.

The production facility has the following areas-

  • Research and Development Facility
  • Antigen Bulk Facility
  • Fill Finish Facility
  • Microbiology Testing Laboratory
  • Chemical Laboratory
  • Animal House
  • Packing and Storage Area
  • Day Store
  • Dispensing Area
  • Stability Area & Retained Sample Area
  • Water Treatment Area
  • Utilities Area
  • Laundry
  • Central Warehouse and Central Power Plant

Whole production and packaging area are properly classified with the help of air supplies through HEPA filters of 99.99% efficacy. Highly sophisticated HVAC systems are used to condition, monitor and supply clean air to the working zone according to the manufacturing zone concept, capture and control any dust, vapor, gas or fume generated, as well as treat re-circulated and/or exhausted air. Temperature and moisture level are maintained at the desired level through this system.

Manufacturing of various vaccines and packaging operations are carried out according to the validated methods required for handling sterile products through systematically qualified machines with full documentation at all stages of operations.

Training programs take place on a regular basis according to written plan. Personnel at all levels undergo general cGMP and Technical Training appropriate to perform their job satisfactorily. Purified water and water for injection plant and distribution systems are designed to maintain the water quality according to the relevant requirements and state-of-the-art engineering design which include e.g. 24 hours run circulation loops, smooth interior surfaces, adequate materials, and minimum flow rates.

At the vaccine facility the activities carried out at this plant includes

  • Vaccine Production- Processing and formulation of human vaccines against the infectious diseases for catering the need of Bangladesh population as well as for export to other countries.
  • Logistic and Ware Housing- Storing of bulks, raw material and packaging materials to meet the requirement of production and storing and dispatching of finished vaccines as per concept of Good Storage Practices.
  • Engineering/Industrial Engineering – In line with vaccine production, health, safety and environmental protection, infrastructure maintenance, machinery and other equipment and utilities maintenance.
  • Quality Assurance/Quality Control – Quality control of all active and raw ingredients, packing materials , reagents and chemicals, plant and personal hygiene, analytical and process method validation, dossier preparations , stability studies and overall quality assurance of vaccines.
  • Animal House Department – To breed and maintain animals required for testing of various vaccines.
  • Plant HR/Administration – Support different units of plant on HR related issues, general services, general logistics and administrative issues.
  • Research & Development Unit – To develop the new vaccines that can independently handle several projects simultaneously involving bacteria and virus.

An Effluent Treatment Plant of high capacity has been built to finally treat the decontaminated waste products for the protection of environment.

The following vaccines are manufactured on the site:

  • Anti viral vaccines
  • Anti bacterial vaccines