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Contamination in the pharmaceutical industry can lead to catastrophic consequences: from compromising with patient safety to affecting business sustainability. Prevention of contamination in manufacturing and production of sterile products is integral for any business to comply with statutory norms and ensure safety of the public at large. State and federal regulatory agencies have stringent expectations and approach on testing pharmaceutical products for contamination.
An aseptic area is a premise in a clean area, designed, constructed, serviced and used with an intention to prevent the microbial contamination of the product. It is important to identify the sources from which the contaminants can enter the aseptic area in order to avoid the contamination of products under operation.
The important sources of contamination in an aseptic area are as follows.
(01) Personnel (02) Buildings and Facilities (03) Equipment and Utensils
(04) Raw Materials (05) Manufacturing Process
Personnel: People who are performing or supervising pharmaceutical manufacturing and packaging processes can be a strong source of contamination. This primarily happens due to:
(01) Lack of training
(02) Inadequate cleanliness and hygiene standards
(03) Direct contact with the materials & products
(04) Lack of personnel protective equipment
(05) Malpractices like eating or drinking in the manufacturing or storage areas
(06) Entry or use of key manufacturing units by unauthorized personnel
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