Email Artikel ini 
Implementasi Manajemen Risiko pada Cold Room Penyimpanan Bahan Baku Produk Biologi Farmasi Sebagai Langkah Penjaminan Kualitas
Abstrak
Sebagai langkah awal penjaminan kualitas produk biologi farmasi, salah satu fokus
utama adalah menjaga stabilitas bahan baku sejak proses penyimpanan. Suhu menjadi
parameter lingkungan kritis yang berpotensi memengaruhi kualitas, sehingga kondisi
penyimpanan dari mulai bahan baku harus dipastikan sesuai spesifikasi. Sebagai upaya
mitigasi risiko, sangat esensial untuk menilai dan mengevaluasi kesesuaian suhu
penyimpanan bahan baku produk. Penelitian ini dilakukan dengan tujuan memastikan
keberlanjutan kualitas bahan baku dan menilai risiko selama periode penyimpanan
bahan baku pada cold room. Penelitian ini dilakukan dengan menempatkan sensor
suhu secara representatif di berbagai area cold room I (CR I) penyimpanan bahan baku
suhu beku -20°C dengan toleransi (-10°C sampai -25°C) dan cold room II (CR II)
penyimpanan suhu dingin (2°C sampai 8°C). Pengukuran suhu dilakukan sepanjang hari
selama satu bulan, dan data hasil pengukuran dicatat menggunakan sistem pencatatan
terintegrasi untuk melihat tren perubahan suhu pada cold room sebagai pertimbangan
evaluasi penilaian risiko. Hasil penelitian menunjukkan bahwa tren suhu pada CR I
terkesan fluktuatif di antara -24,9°C sampai dengan -13,3°C dikarenakan adanya
kegiatan defrost. Sedangkan pada CR II terjadi penurunan suhu dari 4,2°C menuju 2,1°C
dikarenakan terjadi penumpukan embun beku. Meskipun demikian berdasarkan
penelitian yang telah dilakukan kondisi suhu penyimpanan pada CR I dan CR II masih
sesuai dengan rentang spesifikasi. Akan tetapi, diperlukan kajian mengenai cara
pengendalian kestabilan suhu yang optimal seperti optimasi metode defrost kombinasi
kipas dan kompresor, penerapan sistem dual fan, dan Pemantauan suhu real time
dengan sistem sensor terintegrasi Internet of Things (IoT) untuk mencegah risiko.
Kata Kunci
Teks Lengkap:
PDFReferensi
Yu LX, Amidon G, Khan MA, et al. Understanding Pharmaceutical Quality by Design. AAPS J. 2014;16(4):771-783. doi:10.1208/s12248-014-9598-3
De Paoli F, Bishara RH, van Asselt EJ. How to define the right ambient temperature range for storage and distribution of pharmaceutical raw materials. Biologicals. 2021;69:66-69. doi:https://doi.org/10.1016/j.biologicals.2020.12.001
Kumar N, Jha A. Temperature excursion management: A novel approach of quality system in pharmaceutical industry. Saudi Pharmaceutical Journal. 2017;25(2):176-183. doi:https://doi.org/10.1016/j.jsps.2016.07.001
BPOM RI. Pedoman Cara Pembuatan Obat Yang Baik . Badan Pengawas Obat dan Makanan; 2018.
Anacleto S da S, Borges MMC, de Oliveira HL, et al. Evaluation of physicochemical properties as supporting information on quality control of raw materials and veterinary pharmaceutical formulations. J Pharm Anal. 2018;8(3):168-175. doi:https://doi.org/10.1016/j.jpha.2018.01.001
Crommelin DJA, Anchordoquy TJ, Volkin DB, Jiskoot W, Mastrobattista E. Addressing the Cold Reality of mRNA Vaccine Stability. J Pharm Sci. 2021;110(3):997-1001. doi:https://doi.org/10.1016/j.xphs.2020.12.006
Khuluza F, Chiumia FK, Nyirongo HM, Kateka C, Hosea RA, Mkwate W. Temperature variations in pharmaceutical storage facilities and knowledge, attitudes, and practices of personnel on proper storage conditions for medicines in southern Malawi. Front Public Health. 2023;11. doi:10.3389/fpubh.2023.1209903
Iis K, Ida M. Review: Suhu Penyimpanan Material dan Produk Farmasetikal di Gudang Industri Farmasi. Farmaka. 2017;15(4):58-67.
USP. USP 39–NF 34 <1079> Good Storage and Distribution Practices for Drug Products. United States Pharmacopeial Convention; 2016.
Alt N, Zhang TY, Motchnik P, et al. Determination of critical quality attributes for monoclonal antibodies using quality by design principles. Biologicals. 2016;44(5):291-305. doi:https://doi.org/10.1016/j.biologicals.2016.06.005
Fadhilah F, Ghozali D. Mapping Suhu Gudang Narkotika pada Salah Satu Pedagang Besar Farmasi (PBF) di Kota Bandung. Farmaka. 2022;20(3):20-26.
Colberg L, Schmidt-Petersen L, Hansen MK, Larsen BS, Otnes S. Incorrect storage of medicines and potential for cost savings. European Journal of Hospital Pharmacy. 2017;24(3):167. doi:10.1136/ejhpharm-2015-000744
Tabašević I, Milanović DD, Brkić VS, Misita M. Temperature Mapping in Pharmaceutical Warehouse-Framework for Pharmacy 4.0. In: X International Conference Industrial Engineering and Environmental Protection 2020. Available from: https://www.researchgate.net/publication/346025002; 2020:171-175.
Tabašević ID, Jovanović RD, Milanović DD. Experimental and Numerical Investigation of Thermal and Flow Conditions Inside a Large Pharmaceutical Storage after the Ventilation System Failure. Thermal Science. 2022;26(1):801- 814. doi:10.2298/TSCI210522346T
Lutukai M, Bunde EA, Hatch B, et al. Using Data to Keep Vaccines Cold in Kenya: Remote Temperature Monitoring With Data Review Teams for Vaccine Management. Glob Health Sci Pract. 2019;7(4):585. doi:10.9745/GHSP-D-19- 00157
Coccia M. The Fishbone Diagram to Identify, Systematize and Analyze the Sources of General Purpose Technologies. Journal of Social and Administrative Sciences. 2018;4(4):291-303.
Sangshetti JN, Deshpande M, Zaheer Z, Shinde DB, Arote R. Quality by design approach: Regulatory need. Arabian Journal of Chemistry. 2017;10:S3412- S3425. doi:https://doi.org/10.1016/j.arabjc.2014.01.025
Yoon Y, Jeong H, Lee KS. Adaptive defrost methods for improving defrosting efficiency of household refrigerator. Energy Convers Manag. 2018;157:511-516. doi:https://doi.org/10.1016/j.enconman.2017.12.039
Aguiar ML de, Gaspar PD, Silva PD da. Frost Measurement Methods for Demand Defrost Control Systems: A Review. Proceedings of the World Congress on Engineering . 2018;2.
da Silva DL, Melo C, Hermes CJL. Effect of frost morphology on the thermal- hydraulic performance of fan-supplied tube-fin evaporators. Appl Therm Eng. 2017;111:1060-1068. doi:https://doi.org/10.1016/j.applthermaleng.2016.09.165
Maldonado JM, Zsembinszki G, de Gracia A, et al. Control strategies for defrost and evaporator fans operation in walk-in freezers. International Journal of Refrigeration. 2018;91:101-110. doi:https://doi.org/10.1016/j.ijrefrig.2018.05.025
Bai X, Liu S, Deng S, Zhang L, Wei M. A modelling study on the frosting characteristics of a novel dual-fan outdoor coil in an Air Source Heat Pump unit. Appl Therm Eng. 2023;222:119933. doi:https://doi.org/10.1016/j.applthermaleng.2022.119933
Bai X, Liu S, Deng S, Zhang L, Wei M. An optimal control strategy for ASHP units with a novel dual-fan outdoor coil for evener frosting along airflow direction based on GRNN modelling. Energy Build. 2023;292:113136. doi:https://doi.org/10.1016/j.enbuild.2023.113136
Mohsin A, Yellampalli SS. IoT based cold chain logistics monitoring. In: 2017 IEEE International Conference on Power, Control, Signals and Instrumentation Engineering (ICPCSI). ; 2017:1971-1974. doi:10.1109/ICPCSI.2017.8392059
Tsang YP, Choy KL, Wu CH, Ho GTS, Lam CHY, Koo PS. An Internet of Things (IoT)-based risk monitoring system for managing cold supply chain risks. Industrial Management & Data Systems. 2018;118(7):1432-1462. doi:10.1108/IMDS-09-2017-0384
Saha S, Majumdar A. Data centre temperature monitoring with ESP8266 based Wireless Sensor Network and cloud based dashboard with real time alert system. In: 2017 Devices for Integrated Circuit (DevIC). ; 2017:307-310.
Damanab PS, Alizadeh SS, Rasoulzadeh Y, Moshashaie P, Varmazyar S. Failure modes and effects analysis (FMEA) technique: a literature review. Scientific Journal of Review. 2015;4(1):1-6.
Wu Z, Liu W, Nie W. Literature review and prospect of the development and application of FMEA in manufacturing industry. The International Journal of Advanced Manufacturing Technology. 2021;112(5):1409-1436. doi:10.1007/s00170-020-06425-0
Susendi N, Adrian, Sopyan I. Kajian Metode Root Cause Analysis yang Digunakan dalam Manajemen Risiko di Industri Farmasi. Majalah Farmasetika. 2021;6(4):310-321.
WHO. Deviation Handling and Quality Risk Management. World Health Organization; 2013.
Kania A, Roszak M, Spilka M. Evaluation of FMEA Methods Used in The Environmental Management. International Scientific Journal. 2014;65(1):37-44.
Refbacks
- Saat ini tidak ada refbacks.
