Sterile products are free of microbes, pyrogens, and particulates. They also possess high standards of purity and quality. Therefore, the sterilisation methods used during the manufacturing of sterile products should be evaluated and subjected to complex validation procedures.
The final fate of sterility relies on official sterility tests. A manufacturing procedure is said to be validated if it has proved to do what it is meant for.
The data collection and its evaluation, beginning from the development phase up to the production phase of sterile products gives the evaluation proof. Evaluation of processing includes equipment, process, personnel, materials, etc.
The aims of the evaluation of sterilisation process are :
- To build a sterile product,
- To perform a maximum probability level,
- To establish specification and Performance characteristics,
- To provide greater assurance of support for the result,
- To provide specific methodology, process, and equipment,
- To test the final product by validated analytical methods, and
- To verify, calibrate, and maintain the equipment used.
The sterilisation methods are evaluated to ensure yielding the best quality product. The process control and finished product testing do not sufficiently assure the product quality. When a specific part of the total product tested passes the sterility test, it does not indicate that the complete product is sterile.
Sterilisation methods are evaluated to provide a high degree of assurance, indicating that a particular process will reliably form a product that will meet its predetermined specifications and quality assurance.
This proves that any procedure, process, equipment, material activity, or system leads to the expected result and produce quality product. This evaluation concept has been used to encompass various activities from analytical methods used for quality control of drug substance and drug products.
Material equipment is evaluated by a validation protocol carrying the tests to be performed, testing frequency, and results expected that is the acceptance criteria.
What is Sterilization?
Sterilisation is the process of effective killing or removal of transmissible agents or microorganisms (e.g., bacteria, fungi, virus, and prions), from any surface, food, equipment, medications, or biological culture medium.
|Read More Topics|
|Citric acid utilization test|
|Transmission electron microscopy (TEM)|
|Scanning electron microscopy (SEM)|
|Single cell isolation methods|