Regulatory Compliance

Sartorius is a recognized supplier of products and services for the pharmaceutical industry, and product safety and quality are our number one priorities.

The Sterisart® consumables have been especially designed for performing the sterility test. All materials comply with international regulations. The system, itself, is a pre-sterilized and closed system, which eliminates the risk of any manipulation to the system and therefore minimizes the risk of a secondary contamination which leads to a false positive sterility test.

During the manufacturing process of each Sterisart® consumable, the quality is being checked intensively by applying different methods, such as in-process and final quality controls, as well as irreparable destructive testing. In addition to the bacteria challenge test and the method suitability test, the bubble point, flow rate, thickness and wetting time of the membrane are checked before a new batch will be released.

Whenever a medical product comes into contact with the blood of a human or animal, GMP guidelines usually require to conduct the sterility test as written in the pharmacopeia e.g. Eu.Ph. 2.6.1, USP <71>. The preferred method is based on the membrane filtration method. If the product to be examined can not be filtered, then direct growth based methods can be applied. This test is not only to be performed for injectables, catguts and medical devices such as scalpels, but also for ointments, creams and ophthalmics.

The sterility test is being performed on the product in the final container. This happens in particular laboratories operated by the Quality Control (QC) department, before the batch of the given pharmaceutical product can be released into the market. After a period of 14 days plus the day at which the test is being performed, a final visual inspection concludes if the product batch can be released. Whenever, during periodically examination during the incubation time of 14 days, turbidity and/or colonies can be observed, then the result does not comply with the pharmacopeia and the batch is being rejected.