Study of Antimicrobial Power of Amphoteric Disinfectants of Tego Series Used in Pharmaceutical Industry

Document Type : Original Article

Authors

1 Department of Microbiological Quality Control, Hikma Pharm Pharmaceutical Company, 6th October City, Giza, Egypt

2 Compliance and Validation Section Head in Hikma Pharma pharmaceutical Company, 6th October City, Giza, Egypt

3 Compliance Administrator, Quality Control Department in Hikma Pharma Pharmaceutical Company, 6th October City, Giza, Egypt

Abstract

Disinfectant
validation study of 2 amphoteric disinfectants of Tego series–were introduced
in sanitization program of clean room in pharmaceutical facility–has been done
in order to apply them in sanitization process. Carrier test for both
disinfectants was done on different surface material coupon samples
representing stainless steel, wall, floor, and curtain found in classified area
in the plant and compared with other non-sporicidal alcoholic disinfectant
(Isopropyl alcohol 70%) after 1 and 5 minutes exposure against 3 different
representative microorganisms, namely, vegetative form of Bacillus subtilis
(ATCC 6633), Pseudomonas aeruginosa (ATCC 9027), and Candida albicans
(ATCC 10231). After 1 minute, results exceeded 3 log reduction but after 5
minutes no microbial recovery was detected with all biocidal agents with the
four types of surfaces examined. Shelf life study of Tego disinfectants in
comparison with Isopropyl alcohol 70% had been performed –in addition to zero
point 7 and 18 days points were selected and storage was in normal facility
conditions. Results showed that all prepared and diluted biocidal agents (to
the use concentration) in this study were able to reduce microbial bioburden
effectively after 18 days storage of diluted disinfectants within 1 and 5
minutes contact time. Both Tego 51 and 2000 could be used effectively in
disinfection program besides Isopropyl alcohol 70% in controlled manufacturing
area in drug manufacturing facility.

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