Bioprocess and sterilisation equipment is the group of vessels in which living cells are grown to make medicines, the filters that clean the product, and the sterilisers that kill germs on instruments. It is a branch of special-purpose machinery.
Many modern medicines, such as vaccines and insulin, are made by living cells. The cells are grown in a bioreactor, which is a closed steel or plastic vessel kept at a fixed temperature, with a controlled supply of nutrients and air. The cells make the medicine. The liquid is then passed through filters that remove the cells and impurities.
Imagine a plant in Hyderabad with a 2,000-litre bioreactor. The cells grow at 37 °C for around 10 to 14 days. The control system holds the temperature, acidity and oxygen level, and records them. The filters then separate the product, which goes on to purification.
The main risk is contamination. A single unwanted germ that enters a 2,000-litre vessel multiplies along with the cells and can spoil the whole batch, which may be worth many lakhs of rupees. So the equipment is built for sterility. Steel vessels are sterilised with steam after each batch. Newer plants use single-use plastic bags in place of steel vessels, which are thrown away after one batch and need no cleaning. Indian drug plants must follow good manufacturing practice (GMP) and the rules of the drug regulator, which require a full record of every batch.
Everything that touches the product must be sterile, which means free of living germs. A steriliser, also called an autoclave, uses steam under pressure. A common setting is 121 °C for 15 to 20 minutes. Hospitals use the same machines on surgical instruments, as the sterilisers described under medical sterilizers. In a hospital, the same kind of steriliser keeps instruments safe for use on the patients whom patient monitors watch.
Each batch needs a full record of temperatures and times for the regulator. The plant therefore connects its instruments through lab instrument integration software, which collects the readings from them.