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All Journal Organisms: Journal of Biosciences Eruditio : Indonesia Journal of Food and Drug Safety
Henny Setiawati
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Agriculture, Biological Sciences & Forestry Biochemistry, Genetics & Molecular Biology Chemistry Immunology & microbiology Medicine & Pharmacology Public Health Veterinary

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Review: Uji Sterilitas dan Regionalisasi Laboratorium Sterilitas Badan POM: Review: Uji Sterilitas dan Regionalisasi Laboratorium Sterilitas Badan POM Henny Setiawati; Bertha Lolo Lukita
Eruditio : Indonesia Journal of Food and Drug Safety Vol 2 No 1 (2021): Edisi Desember
Publisher : Badan Pengawas Obat dan Makanan

Show Abstract | Download Original | Original Source | Check in Google Scholar | Full PDF (717.563 KB) | DOI: 10.54384/eruditio.v2i1.96

Abstract

Sterile products are preparations that meet the physical, chemical requirements and free from microorganisms, both bacteria and fungi. The sterility test is used as one of the parameters for products released from a manufacturer, even though it is not to guarantee entire of the batch meets the sterile requirements. Sterile preparations are manufactured in a facility that has strict environmental characteristics to minimize the risk of microbial contamination. Sterility testing facilities also requires certain facilities to avoid false-positive results, because sterility testing is only be repeated if there is an error in laboratory testing. Sterility test results that give non-sterile results need to be reviewed whether the results obtained are from the product or due to laboratory errors. Sterility testing facilities require large costs. Expensive testing facilities causes the testing are not conducted by all Provincial Laboratory. The regionalized laboratory at Badan POM is a concept to conduct sterility testing that meets national/international guidelines and reduces large costs. This review is based on a literature study covering sterility testing based on national and international guidelines, sterility testing facilities, limitations of sterility testing and investigation of sterility test failure. Additionally, this review will also describe the concept of regionalization of sterility test laboratories at the Indonesian Food and Drug Authority (Indonesian FDA)
The Effect of Preservatives in Cough Syrups on the Growth of Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, and Candida albicans Kartikawati, Endah; Yus Hargono Cahyaning Yudi; Henny Setiawati; Syumillah
ORGANISMS: JOURNAL OF BIOSCIENCES Vol. 6 No. 1 (2026): Organisms: Journal of Biosciences
Publisher : Pusat HKI, Paten, dan Publikasi Ilmiah Universitas Islam Negeri Raden Intan Lampung

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.24042/8s1h2n39

Abstract

Generally, non-sterile pharmaceutical formulations contain preservatives added to protect the product from microbial growth. Preservatives are used in liquid non-sterile formulations, topical preparations, and other multi-dose forms. This study aims to assess the impact of preservatives in cough syrup on several microorganisms. The study utilized a cough syrup sample (Brand X) that was homogenized with phosphate buffer Solutions pH 7.2   and subsequently spiked with four types of microorganisms with six replicates: Pseudomonas aeruginosa ATCC 9027, Staphylococcus aureus ATCC 6538, Escherichia coli ATCC 8739, and Candida albicans ATCC 10231. Total plate count (TPC) method conducted and analyzed using one-way ANOVA with a 95% confidence level (α = 0.05), followed by post-hoc testing using SPSS 23 software. No growth of P. aeruginosa was observed in samples spiked with an initial concentration of 1.69 x 105 colonies/mL, indicating that the preservative in the cough syrup effectively inhibit P. aeruginosa. For E. coli and C. albicans, no significant difference in growth was observed compared to the initial concentration of microorganisms. S. aureus showed no significant decrease in logarithmic values, with the initial concentration of 1.88 x 105 colonies/mL reducing to 1.09 x 105 colonies/mL. The conclusion of this study is that the preservatives in cough syrup significantly reduce the growth of P. aeruginosa more effectively than S. aureus, E. coli, and C. albicans 
Co-Authors Bertha Lolo Lukita Kartikawati, Endah Syumillah Saepudin Yus Hargono Cahyaning Yudi