DETECTION OF ENDOTOXIN PRODUCING GRAM NEGATIVE BACTRIA THROUGH AN ENVIRONMENTAL MONITORING PROGRAM APPLIED IN AN ANTISERA PREPARATION PLANT

Sherabah, Norhan and Yassin, Aymen and Amin, Magdi and Zedan, Hamadallah (2014) DETECTION OF ENDOTOXIN PRODUCING GRAM NEGATIVE BACTRIA THROUGH AN ENVIRONMENTAL MONITORING PROGRAM APPLIED IN AN ANTISERA PREPARATION PLANT. DETECTION OF ENDOTOXIN PRODUCING GRAM NEGATIVE BACTRIA THROUGH AN ENVIRONMENTAL MONITORING PROGRAM APPLIED IN AN ANTISERA PREPARATION PLANT (45).

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Abstract

Snake bites represent a serious public health problem particularly in rural areas worldwide. Antitoxic sera preparations are antibodies from immunized animals and are considered to be the only treatment option. The purification of antivenom antibodies should aim at obtaining products of consistent quality, safety, efficacy and adhering to the GMP principles. Endotoxins are an integral component of the outer cell surface of Gram-negative bacteria. They are common contaminates of the raw materials and processing equipment used in the manufacturing of antivenoms. In this work, we establish and examine an environmental monitoring program for identification of potential sources of endotoxin producing Gram-negative bacteria throughout the whole process of antivenom preparation. Samples from air, surface and personnel were collected and examined through various stages of manufacturing for the potential presence of Gram-negative bacteria. A validated sterility test was carried out in parallel at the different production steps. The results showed that air contributed to the majority of bacterial isolates detected (48.43%), followed by surfaces (37.5%) and then personnel (14%). The most common bacterial isolates detected were Achromobacter xylosoxidans, Pseudomonas aeruginosa and Ochrobactrum anthropi. A heavy bacterial growth with no fungal contamination was observed in all stages of antivenom manufacturing excluding the formulation stage. Implementation and continued evaluation of quality assurance and quality improvement programs in aseptic preparation is essential in ensuring the safety and quality of these products.

Item Type: Article
Subjects: Pharmaceutical Sciences
Depositing User: NORHAN SHERBAH
Date Deposited: 11 Nov 2017 14:10
Last Modified: 11 Nov 2017 14:10
URI: http://eprints.kku.edu.sa/id/eprint/2061

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