Application Note

Personnel Training In Cleanroom And Aseptic Manufacturing Environments

Source: Azbil BioVigilant, Inc.

Many pharmaceutical, biotechnology, ophthalmology and food and beverage companies manufacture and package their products in cleanrooms or other highly controlled environments using operating procedures designed to minimize contamination of products with foreign materials. Microbial contamination, in particular, is a serious concern because of the potential danger to the health of recipients. A major source of microbial introduction into aseptic manufacturing environments is from the people that work in themA B. Billions of microbes occur naturally on human skin and an estimated 107 skin particles are shed per person per dayC. Rigorous precautions must be taken to prevent human-borne contamination of drugs and other products. In addition to building controls and cleaning and sanitization routines, technicians must wear appropriate protective clothing and equipment such as gowns, gloves, and face masks. Guidelines are also given for appropriate behavior within cleanrooms, for example, to minimize movement and talking and avoid touching the face or hair while working in the room.

Developing good procedures for gowning and cleanroom behavior is an important part of maintaining good control. Equally critical to this process is ensuring that personnel are trained effectively and that they adhere to established procedures while working.

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