PT  - JOURNAL ARTICLE
AU  - Chesky, Sheldon R.
TI  - In Line Validation of Sanitizing Agents in Aseptic Processing Areas
DP  - 1986 Jul 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 169--174
VI  - 40
IP  - 4
4099  - http://journal.pda.org/content/40/4/169.short
4100  - http://journal.pda.org/content/40/4/169.full
SO  - PDA J Pharm Sci Technol1986 Jul 01; 40
AB  - Sanitization is a fundamental discipline necessary to produce a contamination free product in all aseptic fill areas. Each facility in the pharmaceutical manufacturing environment has idiosyncrasies which require a specific sanitization program developed for that facility and the selection of materials for that facility congruous to the type of equipment utilized, the products being manufactured, the geographical location of the facility, and the type of equipment present. Validation of sanitizing materials with the subsequent incorporation of the sanitization program into the S.O.P..s is both a costly and time consuming enterprise. A method for in-line validation of these materials and procedures has been developed to provide: (A) Better control of the known bioburden. (B) Reduction of risk of potential product contamination through pre-screening of the biburden and bioload. (C) Reduction,of the time necessary to validate better sanitization materials and methods of application. (D) Reduced risk of destruction of the manufacturing equipment. (E) Safer, more effective sanitization procedures. (F) Cost effective sanitization with better labor utilization. Identification of the microflora present in the aseptic fill area over the course of several weeks to generate base line data is one of the necessary steps for this method to be incorporated. Laboratory screening using an acceptable method to challenge the known spectrum making up the bioburden coupled with the environmental substrates present in the aseptic fill area are also required in developing this methodology. Biocidal response to the known bioload and the physical and chemical impact of the sanitizing agents on the equipment present in the aseptic fill area are also analyzed in the development of this process.