Abstract
Purpose: To investigate the microbiological quality of blister-packed tablets manufactured and marketed in Jordan in order to assess Good Manufacturing Practice by pharmaceutical industries in the country. Methods: A total of 66 items of 22 registered blister-packed tablet brands were purchased from community pharmacies in Amman. All the items were investigated for total bacterial count and the presence of specified microorganisms using compendial procedures. Results : Out of 66 items purchased, forty eight (72.7 %) products were free from microbial contamination, while 11 (16.7 %) harbored bacteria in counts < 102 cfu/g. The remaining 7 (10.6 %) items contained counts between 102 and < 103 cfu/g. The most commonly encountered contaminant was Bacillus species but specified objectionable bacteria such as Escherichia coli and Staphylococcus aereus were not detected. Aspergillus and Penicillium species were isolated in low numbers from few products. Six of the products with the highest stratified bacterial count were manufactured by one company and were also found to be contaminated with Aeromonas species. Conclusion: This study demonstrates that blister-packed tablets produced by Jordanian pharmaceutical companies are within acceptable microbiological quality but the detection of microbial load in some brands close to the maximum allowable limit suggests the need for better adherence to GMP in the country. Keywords : Blister pack, Community pharmacy, Good Manufacturing Practice, Microbial contamination,Quality control, Tablets
Highlights
Oral dosage forms including tablets are not required to be sterile, but certain quality control measures are essential to keep the microbial content of these preparations safe and acceptable [1]
The extent of microbial contamination in tablets is usually influenced by the microbiological quality of the starting raw materials, packaging materials, personnel that come in contact with the product during the manufacturing process and the production environment as well as equipment
This study is the first to focus on the microbiological quality of blister pack tablets manufactured and marketed in Jordan
Summary
Oral dosage forms including tablets are not required to be sterile, but certain quality control measures are essential to keep the microbial content of these preparations safe and acceptable [1]. The extent of microbial contamination in tablets is usually influenced by the microbiological quality of the starting raw materials, packaging materials, personnel that come in contact with the product during the manufacturing process and the production environment as well as equipment. Contaminants entrapped into the product via the above mentioned routes may not survive for a long period of time due to the lethal effect exerted by the various methods used in tablet production [2]. A recent survey carried out in Egypt [3] demonstrated that microbial contamination of tablets was the lowest of all non-sterile pharmaceutical preparations. High contamination levels were detected in tablets distributed by industries in containers and dispensed to patients by counting
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