The pharmaceutical industry consists of different processes that affect the manufacturing process and product differently. Every process is critical and cannot be avoided or replaced by any other because it has a definite effect on product manufacturing.
Some processes are used as a manufacturing requirement; some are included to enhance & check the product quality; some are included to make the manufacturing process & product safe for human consumption, and so on. Sterilization is also one of many and is used to ensure the safety of a pharma product.
Sterilization removes hazardous living & non-living bodies from the item being sterilized. It is performed in a specified equipment. There are various techniques for performing sterilization, which also affect the equipment construction and application.
Sterilization is a mandatory process in pharma product manufacturing and is a process closely reviewed by regulatory bodies during their inspection. The sterilization record becomes part of the batch record, and no manufacturer is allowed to sell or market its product without sterilization.
Sterilization is used in many industries, such as Food & Beverages, but the pharma industry has its own sterilization requirements, types and applications.
Sterilization in the Pharmaceutical Industry
Sterilization is the process of using high temperatures to remove contaminants, pyrogens, microbial spores, and any object (that could become potentially harmful to the pharma product) from the pharma product. It must also be applied to containers, equipment, accessories or any other item that could come in direct contact with pharma products at any manufacturing stage.
However, for executing sterilization, it is necessary determine its ability to tolerate high temperatures. If for any reason, the item cannot tolerate high temperatures, alternate methods are devised to remove harmful objects.
Its objective is to make patient products safe by removing all objectionable objects. It can be used in several stages where there is a potential for ingress of these foreign bodies.
Sterilization can be achieved using high temperatures through moist or dry heat. Each method has specific applications depending on the items being sterilized, characteristics and foreign objects in consideration.
Whatever the process is, it must be performed based on the guidelines of regulatory bodies or manufacturing principles. It must be suitable for the product and demonstrate efficacy in achieving the required sterilization conditions in all product dimensions.
The sterilization process is monitored by physical, chemical and biological indicators to confirm its authenticity and to detect anomalies in the sterilization equipment and process. Results of these monitoring mechanisms are must be recorded and made part of batch record.
Every item in the product lot must receive the sterilization mechanism. Otherwise, certain products in equipment will not be sterilized and become hazardous for its end user.
The sterilization process must be recorded for later review and presented to the regulatory bodies during their visit. The parameters in the record depend on the requirements of the regulatory bodies, but commonly, it includes the following
· Items being sterilized, such as filter assemblies, glass containers or products
· Time of sterilization
· Set temperature
· Actual temperature, it indicates the efficiency of temperature control system and ensures all items have received the required temperature
As with other equipment and processes in the pharmaceutical industry, both process & equipment for sterilization must be validated according to the regulatory guidelines, and records must be retained and presented to the regulatory bodies. Please note that the validation is different from the Sterilization record, and is performed by quality department and consist of Installation Qualification, Operational Qualification and Performance Qualification
Types of Sterilizati...
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