Review: Sterilisasi Produk Farmasi Steril dengan Metode Through Flow Filtration dan Tangential Flow Filtration

I Gede Yudistira Perdangga Bandem; Kadek Adisthi Pradipthasari; Kadek Indra Aryani; Ni Luh Dian Senja Pratiwi; Putu Siska Angelina Pramesti; I Gusti Ngurah Agung Dewantara Putra

doi:10.61132/obat.v3i5.1675

Authors

I Gede Yudistira Perdangga Bandem Universitas Udayana
Kadek Adisthi Pradipthasari Universitas Udayana
Kadek Indra Aryani Universitas Udayana
Ni Luh Dian Senja Pratiwi Universitas Udayana
Putu Siska Angelina Pramesti Universitas Udayana
I Gusti Ngurah Agung Dewantara Putra Universitas Udayana

DOI:

https://doi.org/10.61132/obat.v3i5.1675

Keywords:

filtration methods, membrane filtration, microbial control, pharmaceutical sterilization, sterile products

Abstract

The production of pharmaceutical sterile products requires strict procedures to minimize the risk of microbial, particulate and pyrogen contamination that can be harmful to the user's health. The selection of the right sterilization method is the key to achieving the desired stability of the final product. Filtration sterilization is one of the oldest methods used for pharmaceutical sterile products. There are two types of feed flow in the method, namely through flow filtration and tangential flow filtration. This review article is prepared through literature search and download of national or international journals with inclusion or exclusion criteria that have been set. Literature sources are accessed online from various sites such as Google Scholar and Pubmed in the range of 2014-2024. The keywords used for journal searches are sterilization, through flow filtration, and tangential flow filtration. This review article reviews and compares the two methods to understand the differences, mechanism of action, and research objectives based on the review article on membrane filtration sterilization. This review aims to provide a better insight into the advantages and disadvantages of each membrane filtration sterilization method, as well as guidance in choosing the appropriate method based on the characteristics of the product to be sterilized. The results showed that through flow filtration is more commonly used in small volume and batch processes because of its simple design, but has limitations in reducing membrane fouling. In contrast, tangential flow filtration allows for continuous processing of larger volumes, with the advantage of minimizing particle build-up on the membrane surface, thus extending membrane life. The choice of method is also influenced by factors such as particle size, viscosity of the solution, sensitivity to heat, as well as operating costs. An in-depth understanding of the Working Principle and application of each method is essential for the pharmaceutical industry to ensure the quality, safety and efficiency of the production process. Thus, this review is expected to be a reference for researchers and practitioners in determining the optimal filtration sterilization strategy according to product needs.

Downloads

Download data is not yet available.

References

BPOM RI. (2018). Peraturan Kepala Badan Pengawas Obat dan Makanan Republik Indonesia Nomor 34 Tahun 2018 Tentang Cara Pembuatan Obat yang Baik. Badan Pengawas Obat Dan Makanan Republik Indonesia, 70–73.

Collins, S. P., Storrow, A., Liu, D., Jenkins, C. A., Miller, K. F., Kampe, C., & Butler, J. (2021). No Title 済無No Title No Title No Title. 4(1), 20–39.

Dian, F., Sawali, I., & Siswanto, Y. (2022). Permeance Dalam Proses Pemisahan Senyawa Proanthocyanidin Menggunakan Metode Dead-. 1, 60–64.

Hanifah, N., Heriyanto, Y., Anggrawati K, H., & Fatikhah, N. (2021). Gambaran Pemahaman Tentang Sterilisasi Alat Kesehatan Gigi Pada Mahasiswa Tingkat Ii Jurusan Keperawatan Gigi. Jurnal Kesehatan Siliwangi, 2(1), 362–368. https://doi.org/10.34011/jks.v2i1.693

Hardono, T., & Supriyadi, K. (2020). Modifikasi Autoclave Berbasis Atmega328 (Suhu). Medika Teknika : Jurnal Teknik Elektromedik Indonesia, 1(2). https://doi.org/10.18196/mt.010210

Ikhtiarini Dewi, E., Kristiana, I., Hadi Kurniyawan, E., Fitria, Y., & Asih Laras Ati, N. (2024). Hubungan Komunikasi Terapeutik Perawat dengan Ketidakberdayaan Pasien Stroke. JI-KES (Jurnal Ilmu Kesehatan), 7(2), 77–85. https://doi.org/10.33006/jikes.v7i2.680

Japonika, H. (2015). Pemisahan dengan Membran Ultrafiltrasi dalam Industri Bioproses. Journal of Bioenginering, 1(1), 1–8.

Ohanessian, K., Monnot, M., Moulin, P., Ferrasse, J. H., Barca, C., Soric, A., & Boutin, O. (2020). Dead-end and crossflow ultrafiltration process modelling: Application on chemical mechanical polishing wastewaters. Chemical Engineering Research and Design, 158, 164–176. https://doi.org/10.1016/j.cherd.2020.04.007

Palit, I. D., Kandou, G. D., & Kaunang, W. J. P. (2021). Hubungan Antara Aktivitas Fisik Dengan Kualitas Hidup Pada Lansia Di Desa Salurang Kecamatan Tabukan Selatan Tengah Kabupaten Kepulauan Sangihe. Jurnal KESMAS, 10(6), 93–100.

Pandu Haryanto, R. T. andayan. (2023). Instansi pemerintah. 03(01), 1–5.

Penshovska, V., Atanaskova, E., Cholakova, I., Anevska Stojanovska, N., Angelovska, V., & Mojsovska, M. (2022). Selection of filter for sterilization using process of membrane filtration based on potential adsorption of Benzalkonium chloride on filter membranes. Macedonian Pharmaceutical Bulletin, 68(03), 289–290. https://doi.org/10.33320/maced.pharm.bull.2022.68.03.139

Rashed, A., El-Katatny, M., Hetta, A., & Hashem, Z. (2020). Validation of moist and dry heat processes used for sterilization and depyrogenation during ampoules manufacturing. Journal of Advanced Biomedical and Pharmaceutical Sciences, 0(0), 0–0. https://doi.org/10.21608/jabps.2020.27282.1083

Shamsuddin, N., Cao, C., Starov, V. M., & Das, D. B. (2016). A comparative study between stirred dead end and circular flow in microfiltration of China clay suspensions. Water Science and Technology: Water Supply, 16(2), 481–492. https://doi.org/10.2166/ws.2015.158

Taufiq, R., & Najmudin. (2017). Rancang Bangun Sistem Informasi Sterilisasi Alat Pada Unit CSSD Berbasis Java di RSUD Kota Tangerang Measures that are used: Requirement Gathering Phase, Design Phase Prototyping, Prototyping Evaluation Phase, Phase Encoding System (Coding), Stage Systems. Jurnal Informatika : Jurnal Pengembangan IT (JPIT), 2(1), 42–49.

Tungadi, R. (2017). Teknologi Sediaan Steril. In Sagung Seto. http://bppsdmk.kemkes.go.id/pusdiksdmk/wp-content/uploads/2017/08/Praktikum-Teknologi-Sediaan-Steril-Komprehensif.pdf

Widarsa, K. T., Astuti, P. A. S., & Kurniasari, N. M. D. (2022). Metode Sampling Penelitian Kedokteran dan Kesehatan. Metode Sampling Penelitian Kedokteran Dan Kesehatan. https://doi.org/10.53638/bp.9786239968908