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Cahyaningsih, Eni
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Agriculture, Biological Sciences & Forestry Biochemistry, Genetics & Molecular Biology Chemistry Medicine & Pharmacology Public Health

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Penerapan ISO 16140-3:2021 untuk Pencacahan Enterobacteriaceae pada Produk Pangan Nagur, Kemala S.; Surati, Sri; Marusaha Sitorus , Aditya Anugerah; Cahyaningsih, Eni; Putri, Fannisa; Wilasti, Yulin
Eruditio : Indonesia Journal of Food and Drug Safety Vol 4 No 1 (2023): Edisi Desember
Publisher : Badan Pengawas Obat dan Makanan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.54384/eruditio.v4i1.195

Abstract

Method verification is one of the steps required to ensure that all methods used meet the standards required for data reliability and accuracy in a laboratory that implements Good Laboratory Practices (GLP). In accordance with ISO 16140-3:2021, the method verification for microbiology testing implemented by calculating the Intralaboratory Reproducibility Standard Deviation (SIR) for implementation verification and eBias value for food item verification. Method verification for enumeration of Enterobacteriaceae in food products using ISO 16140-3 has never been carried out at the Indonesian Food and Drug Authority (FDA) laboratories. Therefore, verification of this method needs to be performed. This study aimed to verify the ISO 21528-2:2017 as reference method for enumeration of Enterobacteriaceae in food products by colony count technique. The selected food item for implementation verification was pasteurized milk while for food item verification, the selected food items were yogurt, traditional preserved egg (telur pindang), sweet and hard candy, seasoning dry powder, worcester sauce and cassava chips. All of selected foods were artificially contaminated with Escherichia coli WDCM 00012. The SIR value obtained was 0.12 ≤ 2× 0,18 (lowest mean value of SR from ISO 21528-2:2017), indicating that the acceptability limit for the implementation verification was met. While the eBias value for all selected food item were less than 0,5 log10, thus the verification study in the National Quality Contol Laboratory of Drug and Food (NQCLDF), Indonesian FDA, meets the acceptance criteria defined in the standard ISO 16140-3:2021.
Performance Characteristics of the Quantitative Method for Staphylococcus aureus in Food Products corresponds to ISO 16140-3: 2021 Putri, Fannisa; Surati, Sri; Sitorus, Aditya Anugerah Marusaha; Nagur, Kemala Suardi; Cahyaningsih, Eni; Wilasti, Yulin; Sihotang, Maria Arieni Eka Devina
Eruditio : Indonesia Journal of Food and Drug Safety Vol 4 No 2 (2024): June Edition
Publisher : Badan Pengawas Obat dan Makanan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.54384/eruditio.v4i2.196

Abstract

Good food sanitation is one of the main pillars for achieving food security goals. High levels of Staphylococcus aureus in food can indicate poor hygiene and handling practices during food production, processing, or storage. Before testing, the laboratory needs to verify the quantitative method for Staphylococcus aureus to produce valid data to ensure food safety and quality. The Centre of National Quality Laboratory of Drugs and Food, Indonesian Food and Drug Authority (FDA) has never verified the Staphylococcus aureus quantification method based on the latest ISO 16140-3:2021. Following the guidelines established in ISO 16140-3:2021, method verification is accomplished by calculating the Interlaboratory Reproducibility Standard Deviation (SIR) for implementation validation and the eBias value for verifying the method's suitability for assessing specific food items. This research was conducted to confirm the ISO 6888-1:2021 as the designated reference method for quantifying Staphylococcus aureus in food products. The cheese was utilized as the test food item to verify the implementation of the method. At the same time, several products, including condensed milk, margarine, baby porridge, cassava chips, and ready-to-eat sausage, were examined as challenging food types. Every chosen food item was artificially contaminated with Staphylococcus aureus WDCM 00034. The SIR value obtained was 0.04 ≤ 2× 0.11 (the lowest mean of SR value from ISO 6888-1:2021), which indicated that the Centre of National Quality Laboratory of Drugs and Food Indonesian FDA was able to implement the method very well. In addition, the eBias value for all types of food tested was below 0.5log10, which showed that the quantitative method for coagulase-positive Staphylococci (Staphylococcus aureus and other types) could be applied in the Centre of National Quality Laboratory of Drugs and Food laboratory for the extensive scope of food.
Validasi Metode Deteksi Shigella dalam Tablet Hisap Obat Kuasi Herawati, Desty; Aprianto, Eko; Cahyaningsih, Eni; Miftahurrohmah, Nur
Eruditio : Indonesia Journal of Food and Drug Safety Vol 4 No 2 (2024): June Edition
Publisher : Badan Pengawas Obat dan Makanan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.54384/eruditio.v4i2.199

Abstract

Lozenges, a quasi-drug used to relieve sore throats, must meet the safety and quality requirements according to Indonesian FDA Regulation No. 7 of 2023 concerning the criteria and procedures for quasi-drug registration, which stipulates that oral preparations of quasi-drugs must be free from Shigella spp—microbial contamination. Contamination by Shigella bacteria can cause diseases such as shigellosis, characterized by symptoms such as diarrhoea, vomiting, and fever. This study aims to validate the Shigella spp—detection method in quasi-drug lozenges using the WHO (Quality Control Methods for Herbal Materials) reference method. Validation was carried out to ensure that this method can be used for routine analysis in the Indonesian FDA laboratory. The guidelines used to validate the microbiological method are the Singapore Accreditation Council (SAC) Guidance Notes C&B AND ENV 002 of 2019 and refer to pharmacopoeias. The study results showed that the WHO (Quality Control Methods for Herbal Materials) method in detecting Shigella sp. has a sensitivity and specificity of 100%, with false positive and false negative rates of 0% each. The detection limit obtained was 3 cfu/g, which meets the requirements (below 10 cfu/g). The method suitability test (optimization) showed that the initial solvent used for sample homogenization in Shigella detection was sufficient using Tryptone Soya Broth (1:10) without additional neutralization or modification procedures at the sample homogenization stage. Based on these results, the Shigella spp. The WHO reference (Quality Control Methods for Herbal Materials) detection method is accurate. It can be applied for routine microbial contamination testing analysis in the Food and Drug Supervisory Agency laboratories.
Co-Authors Eko Aprianto Fannisa Putri Herawati, Desty Kemala S. Nagur Marusaha Sitorus , Aditya Anugerah Miftahurrohmah, Nur Nagur, Kemala Suardi Sihotang, Maria Arieni Eka Devina Sitorus, Aditya Anugerah Marusaha Surati, Sri Wilasti, Yulin