ABSTRACT
The production of pharmaceutical products requires manufacturing in a clean environment or even under totally aseptic conditions. As equipment for use during the manufacturing process will have clearly defined levels of acceptability for use, the freeze dryer must also meet these standards. Amongst these standards is cleanliness or sterility. The freeze dryer should be viewed as another piece of process equip ment and treated in the same manner. If a product is filled aseptically, it would be inadvisable to use a freeze dryer that has not been cleaned or sterilised in an acceptable manner. Many companies operate steril isable freeze dryers, and the current preffered method of sterilisation is steam. There are still many older units in operation that do not have the ability to accept steam sterilisation, and other methods exist to ren der the equipment suitable for its intended purpose. Whatever type of equipment is in use, or its method of operation and maintenance of cleanliness, GMP guidelines should be followed.
