BIOTECHNOLOGY LEARNING CURVES SERIES: Introduction to Vaccines Production (Part 2)

GMP Facilities in the Production Plant...

Malaysian Vaccines and Pharmaceuticals is the only GMP certified vaccine prooduction plant in the country. Many facilities are installed in the killed vaccine production plant in Bangi according to the GMP standards. In this section, I will discuss about some of GMP facilities installed and the GMP procedures undergone by all staffs in the plant.

a) Clean Room System

There are 3 clean rooms in the Killed Vaccine Plant in Bangi. They are namely Egg Lab, Tissue Culture Lab and also Filling Lab. The Egg Lab is used for inoculation and harvesting purposes meanwhile tissue cultures lab is used for inactivation process and Filling Lab used for filling and emulsification processes.

The inside of the rooms are pressurized (higher pressure than outside) to hinder air from the outside from going into the rooms. This is to avoid air-borne contamination into the products. Before any production process being conducted in the clean rooms, they have to be fumigated with potassium permanganate and formalin to sterilize to room. This is to maintain the aseptic condition in the laboratories.

b) Passbox System

The equipments and materials used during the production processes in the clean rooms have to be transferred through a special passage which is called the ‘Passbox System’. This is also to ensure aseptic condition being maintained in the process and reduce risks of contamination. Equipments and materials will be put into the passbox from the outside and transferred to the inside of the clean rooms. Before the door from the inside of the rooms can be opened, the equipments or materials will have to go through a blow of laminar flow air. All clean rooms are interconnected through these passboxes. In the egg laboratory, there is another special passbox which is used to transfer bio-hazardous waste such as harvested eggs to the outside of the production plant. The bio-hazardous waste will be transferred from the passbox to the external autoclaves for waste sterilization.

c)Autoclaves

The functions of the autoclaves are pretty obvious; that is to sterilize using heat, all equipments and materials used in the production line as well as waste from production processes. This type of sterilization is called thermal sterilization. The autoclaves operate at high temperature and pressure. There are 2 autoclaves used in MVP, an internal one for sterilization of equipments and materials and an external one for waste disposal.

d) Cold Rooms & Incubators

Cold rooms play a very vital role as well in the vaccines production plant as most of the materials and by-products involved in the production have to be stored at very low temperature. Most of these materials are proteinous substances and cannot stand high temperature, (i.e over 40° C). Some of the materials like the seed virus and bacteria also need to be chilled so that they will remain inactive and maintain the titre (potency) of the virus and bacteria. Some of the common materials stored in the cold room are as follow: \

· Seed Virus and Bacteria: -30°C

· Bulk Virus and Bacteria: +4°C

· Emulsified and inactivated Virus: +4°C

· Alum-Precipitated BacterialVaccines: +4°C

· Vaccines Product: +4°C

There are two cold rooms in the roduction plant which operate at +4°C and another cold box which operates at -30°C. The following figures show the cold rooms used in the plant.

Besides the cold rooms, another equipment used extensively in temperature control is the incubators. Incubators are also called chillers as they perform dual-functions. Incubators are basically a room in which the temperature can be manipulate to suit different roles. Whe the temperature is maintained at high temperature such as +37°C, it become an incubator. This is usually for the purpose of eggs incubation. If the temperature is maintain at low temperature like +20°C, it will become a chiller. The temperature are manipulated by the control panels in the prouction plant.