Sterilization is a process that effectively kills or eliminates transmissible agents or microorganisms such as fungi, bacteria, viruses and prions from a surface, equipment, foods, medications, or biological culture medium. In the laboratories, the sterility is acquired by exposure of the object that is needed to be sterilized, to chemical or physical agent for a specified time. Some of the wide ranges of agents used as steriliants are:
- elevated temperature,
- ionizing radiation,
- Chemical liquids or gases etc.
The success of the process of sterilization depends upon the choice of the method adopted for sterilization like in case of heat it can either be moist heat sterilization or dry heat sterilization.
Dry heat destroys bacterial endotoxins/pyrogens which are difficult to eliminate by other means and this property makes it applicable for sterilizing glass bottles which are to be filled aseptically and it can only be used for thermo stable, moisture sensitive or moisture impermeable pharmaceutical and medicinal.
These include products like; Dry powdered drugs, Suspensions of drug in non aqueous solvents, Oils, fats waxes, soft hard paraffin silicone, Oily injections, implants, ophthalmic ointments and ointment bases etc.
Reasons why dry heat sterilization is important;
- the need to sterilize small objects, particularly syringes, and
- the apparatus required is comparatively inexpensive when compared with the autoclave.
Batch sterilizer; is one of the appropriate technique for the dry sterilization as it enables proper mixing cum perfect sterilization of the product and the Vacuum inside the chamber ensures that the microbiological and organoleptic properties of the product are preserved that is it does not destroys the microbiological properties of the products that can be proteins denaturation.
Batch sterilizer is consists of a conical shaped vessel fully closed jacketed in which material need to be sterilized is loaded. The vessel is then subjected to vacuum and the material is subjected to steam sterilization. At the same time the material is tumbling inside the vessel. This methos provides the proper mixing cum perfect sterilization of the required product.