Sterility Testing is used to verify that a Pharmaceutical medicine product or medical device is sterile.
Two principal test formats are followed. British and European Pharmacopeias method which have been combined with the United States and Japanese Pharmacopeias along with ISO 11737:1 test method. The pharmacopeia methods are usually used for testing medicinal products and also for checking medical devices to be used for clinical trial purposes before the method of sterilization has been fully validated. The “ISO” method is used when validating a sterilization process for a medical device.
The sterility test is perhaps one of the most critical tests performed by the microbiologist and yet very little of the methodology has changed since its inception. The one area that has changed is the environment in which the test is undertaken
Traditionally, sterility testing has been performed within a laminar flow hood (GMP Grade A), which is sited within a cleanroom (GMP Grade B) but this can lead to false-positive results. These are generally due to contamination caused by the testing environment or technician/technique error and cause additional work in terms of extra documentation. This adds significantly to cost as it delays or prevents the release of the drug product.
Ravona's sterility test isolators provide continuous and complete isolation of the inside of the isolator from the external room environment rapid gas hatch it can provide continuous batch processing.