Many types of pharmaceutical products are required to be sterile. This includes injections, infusions, and pharmaceutical forms for application on eyes and on mucous membranes . These methods of administration are often due to the formulation of the products (e.g., the active ingredient might be inactivated if they were to be ingested). Because of the route of administration, such medicines are required to be sterile. Importantly, if such medicines are not sterile, then this could lead to patient harm or even death. Manufacturing sterile products not only requires the product solution to be sterile. Sterility must encompass the various components required for the production and de-velopment of sterile products. Safeguarding the patient not only extends to manufacturing a sterile product, it needs to include the use of sterile items to administer the drug (such as a sterile syringe and needle) and administering the drug under aseptic conditions, using trained medical or nursing practitioners. Thus, sterile manufacturing itself is a continuum that stretches from development to manufacturing, to the finished product, to marketing and distribution, and to utilization of drugs and biologicals in hospitals, as well as in patients’ homes. There is no generic approach to the manufacturing of sterile products. Each plant or process will differ in relation to the technologies, products, and process steps. The common point
is that a product is produced that is sterile and where there is no risk of contamination until the contents of the outer packaging are breached (such as through the injection of a needle through a bung on a product vial).
12.2 Sterility Sterility can be defined as “the absence of all viable microorganisms.” Therefore,
something would be deemed sterile only when there is complete the absence of viable microorganisms from it. Sterility is an absolute term. Either something is sterile or it is not. There is no such thing as “slightly sterile” or “almost sterile.”
Following on from this, sterilization can be taken to mean the use of a physical or
chemical procedure to destroy all microbial life, including highly resistant bacterial endospores. This destruction of bacterial spores means that sterilization is a complete process for the destruction of life, unlike disinfection, which refers to the reduction of a microbial population by destruction or inactivation. Importantly, this simple definition refers to microorganisms that are “viable” (that is bacteria, fungi, and viruses that are capable of reproducing under the correct condi- tions). It does not, however, refer to the absence of microbial by-products. By-products
Identification of bacteria using staining techniques (simple, Gram’s &Acid fast staining) and biochemical tests (IMViC). Study of principle, procedure, merits, demerits and applications of physical, chemical gaseous,radiation and mechanical method of sterilization. Evaluation of the efficiency of sterilization methods. Equipments employed in large scale sterilization. Sterility indicators.