Study of Antimicrobial Power of Amphoteric Disinfectants of Tego Series Used in Pharmaceutical Industry | ||||
| Egyptian Academic Journal of Biological Sciences, G. Microbiology | ||||
| Article 2, Volume 6, Issue 1, June 2014, Page 17-27 PDF (261.36 K) | ||||
| Document Type: Original Article | ||||
| DOI: 10.21608/eajbsg.2014.16626 | ||||
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| Authors | ||||
| Mostafa Essam Eissa1; Mohab Abd El Naby Kamel2; Mohamed Mohamed Beshir3 | ||||
| 1Department of Microbiological Quality Control, Hikma Pharm Pharmaceutical Company, 6th October City, Giza, Egypt | ||||
| 2Compliance and Validation Section Head in Hikma Pharma pharmaceutical Company, 6th October City, Giza, Egypt | ||||
| 3Compliance 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. | ||||
| Keywords | ||||
| Amphoteric; Tego Sanitization program; carrier test; shelf life; bioburden | ||||
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