F) Personnel
The most ideally planned processes can be rendered ineffective by personnel who do not have the right attitudes or training. The personnel who produce sterile products usually are non-professional person, supervised by those with professional training. To be effective operators, they must inherently neat, orderly, reliable and alert and have good manual dexterity. They should be appreciative of the vital role that every movement lies in determining the quality of final product, it its freedom from contaminants.
All employees should be in good health and should be subjected to periodic physical examinations. They should understand their responsibility to report the developing symptoms of cold, sore throat or other infectious diseases, so that they can be assigned to
a less critical area until they have fully recovered.
The attire won by personnel in the aseptic areas usually consists of sterile coveralls, hoods, face masks and show covers. Sterile rubber gloves also may be required.
Personnel entering the aseptic areas should be required to follow a definite preparatory procedure. This should include removing at least outside street clothing, washing the hands and arms thoroughly with a disinfectant soap, and donning the prescribed uniform.
A full body water and soap shower would be essential n most biologic products processing plants – usually, both when entering and leaving the area to control contaminations in both directions, between personnel and the product. Since people are continually shedding viable and non-viable particulate matter from body surfaces, uniform are worn to help to control this emission. The uniform should, preferably be of coverall type and made of synthetic fibers such as Dacron. Dacron cloth
is made of a continuous fiber, which makes it essentially lint-free and in air conditioned room, is acceptably comfortable.
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