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All Journal Jurnal Riset Ilmu Kesehatan Umum dan Farmasi Medical Laboratory Journal
Dzakiya Zhihrotulwida
Universitas Anwar Medika
Health Professions Public Health

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Review Artikel : Sediaan Steril Injeksi Miya Hartini Nur Wakhid; Fina Nikmatul W; Windi Tri Wahyuni; Rizki Amalia Putri; Dewi Nur Halisa; Magdalena Kasih Belaon Lebuan; Dewi Rahmawati; Dzakiya Zhihrotulwida; M. Fithrul Mubarak
Jurnal Riset Ilmu Kesehatan Umum dan Farmasi (JRIKUF) Vol. 3 No. 1 (2025): Januari : Jurnal Riset Ilmu Kesehatan Umum dan Farmasi (JRIKUF)
Publisher : LPPM STIKES KESETIAKAWANAN SOSIAL INDONESIA

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.57213/jrikuf.v3i1.506

Abstract

Sterile injection preparations are liquid pharmaceutical preparations that are specifically designed to be administered directly into the body through injection using a sterile syringe or clean injection device. The main requirement for sterile injection preparations is that they must be free from microorganisms, foreign particles, and pyrogenic substances that can trigger fever or infection reactions in patients. Testing the quality of sterile injection preparations includes various aspects, ranging from sterility testing, pyrogenicity testing, clarity testing, to stability testing during the shelf life. Stability testing aims to ensure that the preparation remains safe, effective, and stable until its expiration date. The purpose of this study was to determine the evaluation of sterile injection preparations. The method used is by reviewing journals from Google Scholar, Pubmed, etc. from 2018-2024.  
CPOB Sediaan Steril Dewi Rahmawati; Dzakiya Zhihrotulwida; M. Fitrul Mubarak; Ismatun Maulidiyah; Elsa Saqila; Aprilia Puji; Ika Hepi; Silvi Novita Permatasari
Calory Journal Medical Laboratory Journal Vol. 2 No. 4 (2024): December : Medical Laboratory Journal
Publisher : LPPM STIKES KESETIAKAWANAN SOSIAL INDONESIA

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.57213/caloryjournal.v2i4.507

Abstract

The importance of Good Manufacturing Practices (GMP) in the pharmaceutical industry to ensure the quality and safety of drug products. GMP aims to ensure that all pharmaceutical preparations, including sterile drugs such as infusions and injections, meet strict quality standards. Sterility testing is an important aspect even though it has limitations, such as long incubation times and low probability of detecting contamination. Therefore, any sterility test results that do not meet the requirements must be further investigated to find the cause, either from laboratory errors or contamination in the production process. In addition, the implementation of technical and managerial aspects in accordance with GMP, such as temperature and humidity control, is very important to maintain product quality. This article also highlights the use of modern technologies, such as Service Oriented Architecture (SOA), to improve efficiency and transparency in the drug production process, so that it can meet all the provisions set.
Co-Authors Aprilia Puji Dewi Nur Halisa Dewi Rahmawati Elsa Saqila Fina Nikmatul W Ika Hepi Ismatun Maulidiyah M. Fithrul Mubarak M. Fitrul Mubarak Magdalena Kasih Belaon Lebuan Miya Hartini Nur Wakhid Rizki Amalia Putri Silvi Novita Permatasari Windi Tri Wahyuni