Çinel Köksal KARAYILDIRIM, Veysel Umut ÇELENK

Benzalkonyum Klorür İçerikli Dezenfektanın EN 13727 Standardına göre Antibakteriyel Etkinliği, Kimyasal Analizi ve Validasyon Çalışmaları

Bu çalışmada, biyosidal dezenfektan olarak yaygın bir şekilde kullanılan benzalkonyum kolürürün (BAK) kimyasal analizinin, antibakteriyel etkinlik testinin ve validasyon çalışmalarının prensiplerinin ortaya konması amaçlanmıştır. % 20 konsantrasyonda BAK içeren dezenfektan prototip olarak kullanılmıştır ve aktif madde içeriği kimyasal analiz ile doğrulanmıştır. Ayrıca LC-MS/MS metodu ile ürün içeriğinde yer alan BAK homologları (n-C12 and n-C14) tanımlanmıştır. Validasyon sonuçları ile kromotografik metodun güvenilirliği doğrulanmıştır. Aktif maddenin onaylanmısının ardından, mikrobiyolojik etkinlik testleri E. coli K12, S. aureus, P. aeruginosa ve E. hirae bakterilerine karşı gerçekleştirilmiştir. Test ürünü ile 1 dakikalık temasın ardından bütün bakteri şuslarına karşılık 5 logartimik azalmadan fazla düşüş elde edilmiştir. Bu çalışmanın amacı, test ürününün kimyasal analizlerinin validasyonunu kromotografik bir metot olan LC-MS/MS ile değerlendirmektir. Ayrıca çalışma, BAC içerikli dezenfaktanların EN standartları ile antibakteriyal etkinliğinin ortaya konmasına ışık tutmaktadır. Bu sonuçlarla biyosidal ürünlerin üretim ve pazarlama öncesi gerçekleştirilen kimyasal ve mikrobiyobiyolojik analizlerinin önemi ortaya koymuştur. Bu çalışma biyosidal analizlerinin EU standartlarına göre gerçekleştirildiği ilk çalışmadır.

Antibacterial Efficiency of Benzalkonium Chloride Base Disinfectant According to European Standard 13727, Chemical Analysis and Validation Studies

This study was aimed to provide principle of the chemical analyses, antibacterial efficiency test and validation procedures of the most commonly used benzalkonium chloride (BAC) base disinfectant as a biocide. Disinfectant which comprised 20 % BAC concentration was used as a prototype product and active substance was verified with chemical analysis. Additionally, BAC homologs (n-C12 and n-C14) in the product were identified by LC-MS/MS method. The validation results also confirmed the reliability of the chromatographic method. After active substance was confirmed, microbiological efficacy test was carried out against E. coli K12, S. aureus, P. aerugionas and E. hirae. Both bacterial strains were showed more than 5 logaritmic reduction after exposure for 1 min. to test product. The aim of this study was to evaluate the validation of chemical analysis of the test product by LC-MS/MS which is developed chromatographic method. Moreover the present study highlights that the antibacterial efficacy of BAC based disinfectant according to European National (EN) Standard. These results exhibited that chemical and microbiological analyses were significantly important before manufacturing and marketing processes of the biocidal products. This was the first study on biocides analysis which was conducted according to the European standard.

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Celal Bayar Üniversitesi Fen Bilimleri Dergisi-Cover

ISSN: 1305-130X
Başlangıç: 2005
Yayıncı: Manisa Celal Bayar Üniversitesi Fen Bilimleri Enstitüsü

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