Ditemukan 122293 dokumen yang sesuai dengan query
Chrisandy Ramadhanti
"Vaksin merupakan unsur biologis yang memiliki karakteristik khusus dan sensitif terhadap temperatur, vaksin rentan mengalami penurunan mutu dan efektivitas apabila terpapar oleh temperatur yang tidak sesuai dengan karakteristik temperatur penyimpanan yang telah dipersyaratkan. Upaya dalam menjaga mutu dan efektivitas vaksin tidak semata-mata hanya ditentukan dari cara vaksin diproduksi dengan baik dan benar, tetapi salah satu urgensi yang dapat menjadi titik kritis penentuan mutu dan efektivitas vaksin yaitu perlakuan selama proses pengelolaan. PBF berperan penting dalam mengelola vaksin mulai dari penerimaan, penyimpanan hingga pendistribusian vaksin ke berbagai fasilitas kesehatan. Sebelum vaksin didistribusikan, vaksin akan melalui proses penyimpanan pada alat berupa chiller. Selama proses penyimpanan, perlu dilakukan pemantauan suhu vaksin secara berkala. Pemantauan suhu secara berkala berkaitan erat dengan alat yang digunakan selama proses penyimpanan vaksin yaitu chiller. Penggunaan chiller sebagai alat penyimpanan vaksin harus melalui tahap validasi sesuai persyaratan yang telah ditetapkan yaitu dapat mempertahankan suhu penyimpanan antara 2-8°C. Hal ini bertujuan sebagai acuan standar operasional selama proses penyimpanan vaksin berlangsung. Melalui tugas khusus ini dapat diketahui bahwa chiller yang digunakan selama proses penyimpanan produk vaksin di PT. Kimia Farma Trading & Distribution Cabang Jakarta 1 telah valid dan mampu mempertahankan kestabilan suhu pada rentang 2-8°C selama jangka waktu ± 20 jam bahkan lebih apabila chiller dalam kondisi dinyalakan.
Vaccines are biological elements that have special characteristics and are sensitive to temperature, vaccines are prone to decreasing quality and effectiveness when exposed to temperatures that do not match the required storage temperature characteristics. Efforts to maintain vaccine quality and effectiveness are not solely determined by how vaccines are produced properly and correctly, but one of the urgency that can become a critical point in determining vaccine quality and effectiveness, namely treatment during the management process. PBF plays an important role in managing vaccines from receipt, storage to distribution of vaccines to various health facilities. Before the vaccine is distributed, the vaccine will go through a storage process in a chiller. During the storage process, it is necessary to periodically monitor the temperature of the vaccine. Periodic temperature monitoring is closely related to the equipment used during the vaccine storage process, namely the chiller. The use of a chiller as a vaccine storage device must go through a validation stage according to predetermined requirements, namely being able to maintain a storage temperature between 2-8°C. This is intended as a reference for operational standards during the vaccine storage process. Through this special assignment, it can be seen that the chiller used during the process of storing vaccine products at PT. Kimia Farma Trading & Distribution Jakarta Branch 1 is valid and able to maintain temperature stability in the range of 2-8°C for a period of ± 20 hours or more if the chiller is turned on."
Depok:
2022
PR-pdf
UI - Tugas Akhir Universitas Indonesia Library
Ria Artha Rani
Pharmaceutical disributor is one of the parties distributing pharmaceutical products including Cold Chain Products (CCP). Kimia Farma Trading & Distribution (KFTD) Jakarta 3 Branch is one of the PBFs that distributes CCP to various health care facilities. Therefore, KFTD Jakarta 3 must have a distribution procedure that can guarantee the stability of the distributed CCP. In order to ensure the ability of the distribution process to maintain product stability, it is necessary to validate the CCP distribution process from KFTD Jakarta 3."
Depok: Fakultas Farmasi Universitas Indonesia, 2022
PR-pdf
UI - Tugas Akhir Universitas Indonesia Library