This guidance is intended to provide guidance for the validation of sterility testing systems for sterile pharmaceuticals, biological products, raw materials, excipients, and other varieties. A sterility test isolator is a device that provides a sterile environment for a product sterility test.
Closed isolators are not directly connected to the external environment, using sterile interfaces or rapid transfer channels for material transfer, generally for sterility inspection; open isolators allow material to enter through the hatch, which has some pressure to prevent microbes Entry. The item can be delivered aseptically into the isolator, which keeps the internal space of the isolator completely isolated from the external environment throughout the transfer. The inside of the isolator can be sterilized repeatedly, and the inner wall can be treated with sporicide to remove all bioburden. After the sterilization is completed, the isolator is transported to the inside through a high efficiency air filter (HEPA) or higher air filter. Clean the air to maintain an internal sterile environment. The use of the isolator fundamentally avoids the direct contact between the operator and the experimental article. The operator does not need to wear a special clean clothes, but operates the in-cabin items and instruments through the operating gloves or the half-length operating suit on the isolator. Glove-sleeve assemblies or half-length suits are an integral part of the isolator compartment, made of a soft material and compatible with the sterilant used.
Therefore, the use of the isolator for sterility testing can avoid contamination of the experimental articles and auxiliary equipment, and improve the accuracy of the sterility test results.
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