Home page

Summary of Methods in the Pharmaceutical Industry

Release time：2015-07-29

Sterile articles are defined as those that contain no viable microorganisms. However, for any given batch of products, sterility cannot be guaranteed nor can it be conclusively demonstrated by testing, since it is impractical to perform sterility testing on every individual unit. In fact, physical and chemical methods of testing reveal that the microbial kill curve follows a logarithmic pattern; therefore, the sterility standard for a batch is generally defined in probabilistic terms as the level at which the probability of contamination is reduced to an acceptably low value, typically expressed as the Sterility Assurance Level (SAL), which represents the probability of surviving microorganisms after processing. The SAL for the final product should generally not be lower than 10⁻⁶, meaning that the probability of surviving microorganisms must not exceed one in a million. The Sterility Assurance Level is closely related to the quantity and characteristics of microorganisms present in the article; consequently, throughout all stages of production, a variety of effective measures—including filtration—should be implemented to minimize microbial contamination of the product and keep it within specified limits. The Sterility Assurance Level achieved by the finished product can be confirmed through validation.

The sterility assurance of a product does not rely on sterility testing of the finished product; rather, it depends on the adoption of qualified manufacturing processes, stringent GMP compliance, and a robust, comprehensive quality assurance system throughout the production process. The design and validation of these processes must comprehensively consider factors such as the characteristics of the product or article to be sterilized, the efficacy and cost-effectiveness of the sterilization method, and the integrity and stability of the product or article.

Validation of the manufacturing process is a critical and essential component of sterility assurance. For products, including final containers and packaging, the relevant methods must be validated prior to their implementation before they can be put into formal use. The validation shall cover:

⑴ Draft the validation plan and establish the evaluation criteria.

⑵ Confirm Equipment Technical documentation is complete, installation is correct, and the system is in normal operating condition (Installation Qualification).

⑶ Verify that critical control equipment and instruments operate normally within their specified parameter ranges (Operational Qualification).

(4) Conduct repeated tests using actual or simulated items, specify the ranges for each parameter, and verify that the results meet the specified requirements (performance qualification).

⑸ Compile and refine all documents and records, and prepare a comprehensive validation report.

During routine production, the operation of process procedures shall be monitored to ensure that all critical process parameters—such as temperature, pressure, time, humidity, gas concentration, and absorbed radiation dose—are within the ranges established during validation. Critical equipment and processes used in validated procedures shall be re-validated on a regular basis. Whenever significant changes are made to the procedure—including alterations to the placement, loading method, or quantity of items within the chamber—re-validation shall be performed.

In this probabilistic sense, the sterility assurance of a product does not rely on sterility testing of the finished product; rather, it depends on the adoption of qualified manufacturing processes, stringent GMP compliance, and a robust, comprehensive quality assurance system throughout the production process. This means that monitoring of the batch manufacturing process provides a more accurate reflection of the product’s sterility assurance level than the results of batch sterility testing. Sterility assurance is closely related to the extent of pre-product contamination and the characteristics of the contaminating microorganisms. Therefore, it is essential to rigorously monitor pre-product microbial contamination levels and the tolerance of contaminating microorganisms, and to implement a range of measures at every stage of production to minimize contamination, thereby ensuring that microbial contamination is kept within specified limits.

Otherwise, appropriate measures shall be taken to reduce contamination and eliminate resistant strains, and the manufacturing process may even need to be re-validated. Recontamination of finished products must be prevented. In all cases, the container and its sealing system shall be required to ensure that the product remains sterile throughout its shelf life.

How is the sterilization efficacy of a steam-pressure sterilizer verified?

Verification of Sterilization Quality

+ More Products

2025-05-19

The 2025 Shanghai Pujiang International Intellectual Property Forum Concludes Successfully, with Jiangyin Binjiang Medical Equipment Co., Ltd.

Learn More →

2021-06-09

Solemn Statement

Recently, Jiangyin Binjiang Medical Equipment Co., Ltd. (hereinafter referred to as “our company”) discovered that information about our products and promotional materials are being posted on Taobao and various other online platforms. We hereby solemnly declare that, apart from our official website, our company has never registered any merchant accounts on any other online platforms, nor has it ever published product information or promotional materials on such platforms.

Learn More →

2020-11-25

How to Properly Use Electric Heating Equipment Such as Oven Dryers

The oven must be placed indoors in a dry, level location to prevent vibration and corrosion. Always ensure that the power supply is properly monitored: select a power switch and wiring that match the oven’s power consumption and capacity, and provide a reliable grounding connection.

Learn More →