Biologicals Production Facilities

The Biologicals Manufacturing Division (BMD) is well equipped with facilities dedicated to vaccine production and storage. BMD houses the Production Department, Quality Control Department, Purified Cobra Anti-Venom (PCAV) Injection Facilities, BCG Vaccine Facilities, Quality Control (QC) and Testing Facilities, and Support Facilities.

Production Department

  1. Purified Cobra Anti-Venom (PCAV) Section. Supports the Biologicals Manufacturing Division in Good Manufacturing Practices (cGMP) injection of Purified Cobra Anti-venom for snake or cobra bite victims in different regions of the country.
  2. BCG Section. Responsible for the production of Good Manufacturing Practices (cGMP) grade freeze-dried BCG vaccine and its diluent for the immunization of newborn and children against tuberculosis.
  3. Labelling and Packaging Section. This section is responsible for the labelling and packaging of vaccines produced by RITM.

Quality Control Department

The Quality Control Department of BMD is concerned with conducting quality control tests of biologicals produced or manufactured by the different production units of the division. The control tests are conducted in accordance with the World Health Organization standards. It is further divided into two sections:

  1. Microbiology Section. This section is responsible for the quality control testing of intermediate and finished products produced and filled by the Purified Cobra Anti-Venom and BCG sections.
  1. This section is responsible for the chemical analysis of products produced and filled by the production sections, as well as in testing and examination of starting materials.

Purified Cobra Anti-Venom (PCAV) Injection Facilities

1

Gowning Room. This area is where proper gowning procedure is observed by wearing standard laboratory garments to ensure protection of the product from contamination.

2

Washing Area. This area is where materials intended for use are washed and decontaminated.

3

Preparation Room. Preparations for media, chemical solutions, glassware, and outfit are being done in this area. Materials are sterilized using autoclave prior to use.

4

Toxoid Room. This area is where Drying of Venom, Preparation of 1% Cobra Venom Toxoid (CVT), and Plasma separation takes place.

5

Plasma Fractionation Room. This area is where Purification, Diafiltration, and Formulation of Bulk concentrate are being done.

6

Filling Room. Formulated bulk product ready for dispensing using aseptic technique is done in this room.

7

Visual Inspection Room. This room is where finished products in ampoules undergo visual inspection, labelling and packaging.

8

Cold Room Storage. This room is used for safe keeping of collected horse blood and finished product in ampoules. Temperature requirement is between 2°C to 8°C.

BCG Vaccine Facilities

9
Washing and Preparation Area. This area is used for washing of glassware, preparation of outfits for sterilization, media preparation and autoclaving.

9a

Inoculation Room. This room functions for the maintenance and inoculation of the Bacillus Calmette–Guérin strain. It is also used as an area for vaccine preparation.

9b

Filling Room. This area is where the filling of the formulated final bulk takes place.

9c

Vial Washing Room. This is a sterile area used for the preparation and autoclaving of vials and stopper.

9d

Freeze Drying Room. This is where Freeze Drying or Lyophilization is performed. Lyophilization is a process in which water is removed from a product after it is frozen and placed under a vacuum, allowing the ice to change directly from solid to vapor without passing through a liquid phase. The process consists of three separate, unique, and interdependent processes; freezing, primary drying (sublimation), and secondary drying (desorption).

Quality Control (QC) and Testing Facilities

The Biologicals Production Department has three major laboratories, namely:

  1. PCAV – QC Laboratory
  2. BCG – QC Laboratory
  3. QC – Chemistry Laboratory

The said laboratories have basic facilities like Changing or Gowning Room, and Washing and Decontamination Area. Both PCAV and BCG QC Laboratories are equipped with:

  1. Sterile Room. A highly purified and regulated room used for sterility testing and inoculation of sample.
  2. Preparation and Testing Room. This area is used for media preparation, serial dilution of sample, microscopic examinations and environmental testing for water.
  3. The QC Chemistry Laboratory on the other hand, serves as a testing area for physio-chemical analysis for both PCAV and BCG samples.

Support Facilities

  1. Water for Injection (WFI) Facility. It is the water source of the Biologicals Manufacturing Division for production and quality control laboratory use.
  2. Animal Laboratory and Animal Facility. This area is used for the maintenance, breeding, care, and supplying laboratory animals to be used in the testing of biologicals produced by the division.