Sterility Assurance Level and Aseptic Manufacturing Process in Pharmaceuticals.

Contamination of sterile areas is a concerned issue in pharmaceutical companies, it is very hard to overcome these issues if you want to get aseptic environment. Bioburden increases in a manner that microorganism travels along with dust particle and these particle destroys the aseptic environment. There are different sources through which contamination can occur in aseptic environment but the main source is the airborne particles. The predictable bacteriological value of the product can be assessed by process repetition by the containers used for filling with bacteriological medium. On the other hand, these tests are not much sensitive to indicate the level of contamination particles below 1000 and these tests are also limited in number. This paper includes the discussion about the procedure to control the contamination and the means of contamination through airborne particle of aseptic room. The discussion includes the counting of CFU by plate exposure method and fill trial test to check the level of contaminating microorganism in aseptic environment. The confidence must be found in the methods to calculate the contaminants if they are to be adopted. The methods used currently in our pharmaceuticals are lack of accuracy and they are suggested to be improved to enhance their accuracy. The company's financial ability, reputation and license to manufacture is seriously affected by contamination in aseptic area. To guarantee the proper and validated monitoring of environmental to detect contaminants, regulatory GMP codes for the manufacturing of human as well as veterinary products aseptically are provided that show the frequency of sterility failure. Autoclave, driers, Ethylene Oxide and irradiation, either with Cobalt 60 Gamma or with E Beam affects the stability of the drug filled in aseptically. Therefore the product that are either biological or pharmaceutical or it may be biotechnological product all are filled in aseptic environment. [ABSTRACT FROM AUTHOR]