Hasil Pencarian  ::  Simpan CSV :: Kembali

Abstrak :
Produksi sediaan di Industri Farmasi tidak terlepas dari peran apoteker pada pengawasan mutu terhadap bahan baku yang digunakan, salah satunya adalah purified water berdasarkan spesifikasi fisik, kimia, dan mikrobiologi. Purified water yang digunakan oleh PT Darya Varia Laboratoria Plant Gunung Putri tersimpan pada Carboy sebelum digunakan oleh Departemen Produksi sehingga waktu simpan perlu diketahui dengan protokol studi yang jelas untuk mengetahui ketahanan mutu purified water dan menentukan waktu pencucian dan pergantian purified water. Protokol studi dibuat melalui studi literatur, wawancara dengan salah satu laboran dan salah satu analis Quality Control (QC) Laboraorium Kimia, penentuan parameter dan periode pemeriksaan purified water. Berdasarkan proses tersebut, dihasilkan protokol studi yang telah disetujui oleh supervisor Laboratorium Kimia dan Mikrobiologi, manager QC, dan manager QA dengan isi berupa tujuan, cakupan, tanggung jawab, peralatan dan bahan, prosedur, dan kriteria penerimaan seperti pemerian, pH, konduktivitas, Total Organic Carbon (TOC), Total Count Bacteria, Escherichia coli, dan Pseudomonas aeruginosa disertai form pemeriksaan pada hari ke-0, 1, 2, 3, 4, 7, 10, dan 14. ......The production of preparations in the Pharmaceutical Industry cannot be separated from the role of pharmacists in quality control of the raw materials used, one of which is purified water based on physical, chemical, and microbiological specifications. Purified water used by PT Darya Varia Laboratoria Plant Gunung Putri is stored in Carboy before being used by the Production Department so that the shelf time needs to be known with a clear study protocol to determine the quality resistance of purified water and determine the time for washing and changing purified water. The study protocol was made through literature studies, interviews with one of the laboratory assistants and one of the Quality Control (QC) analysts of the Chemistry Laboratory, determining the parameters and period of purified water inspection. Based on this process, a study protocol was produced that was approved by the Chemistry and Microbiology Laboratory supervisor, QC manager, and QA manager with contents in the form of objectives, scope, responsibilities, equipment and materials, procedures, and acceptance criteria such as description, pH, conductivity, Total Organic Carbon (TOC), Total Count Bacteria, Escherichia coli, and Pseudomonas aeruginosa accompanied by inspection forms on days 0, 1, 2, 3, 4, 7, 10, and 14.

Abstrak :
Air merupakan bahan yang paling banyak digunakan dalam kehidupan, termasuk proses produksi berbagai jenis industri. Air memiliki beberapa tingkatan kualitas yang dibedakan berdasarkan proses pemurniannya, salah satu jenisnya adalah air murni. PT Forsta Kalmedic Global menggunakan air murni untuk keperluan sanitasi dan bahan pendukung pembuatan kultur media yang terdistribusi dalam beberapa ruangan produksi. Pemantauan kualitas air murni secara rutin dilakukan untuk memastikan bahwa air murni yang digunakan dalam rangkaian proses produksi memenuhi persyaratan kimia dan mikrobiologis yang ditetapkan. Pada tugas akhir ini, evaluasi terhadap hasil pemantauan air murni, khususnya pada ruangan Mixing selama periode bulan Agustus – Desember 2022 dilakukan untuk menilai kualitas dan kesesuaiannya terhadap persyaratan air murni yang telah ditentukan. Evaluasi yang dilakukan meliputi uji total karbon (TOC), uji konduktivitas, uji pH, dan uji microbial limit. Pengambilan data dilakukan secara retrospektif dengan mengumpulkan data hasil pemantauan air murni bulan Agustus – Desember 2022 yang kemudian dievaluasi berdasarkan persyaratan USP. Hasil evaluasi terhadap total karbon, konduktivitas, pH, dan total mikroba berturut-turut adalah 0.60 – 44.90 ppb; 0.086 – 0.982 uS/cm;, 6.30 – 6.90; dan <1 CFU/mL. Berdasarkan hasil tersebut, kualitas air murni PT Forsta Kalmedic Global yang dihasilkan oleh mesin pada bulan Agustus – Desember 2022 telah memenuhi spesifikasi. ...... Water is the most widely used material in life, including the production processes of various types of industry. Water has several levels of quality which are differentiated based on the purification process, one type of which is purified water. PT Forsta Kalmedic Global uses purified water for sanitation purposes and as supporting material for making culture media which is distributed in several production rooms. Purified water quality monitoring is routinely carried out to ensure that the purified water used in the production process meets the specified chemical and microbiological requirements. In this research, an evaluation of the results of purified water monitoring, especially in the Mixing room during the period August – December 2022 was carried out to assess its quality and suitability to the specified purified water requirements. Evaluations carried out include total carbon (TOC) tests, conductivity tests, pH tests and microbial limit tests. Data collection was carried out retrospectively by collecting purified water monitoring data from August – December 2022 which was then evaluated based on USP requirements. The evaluation results of total carbon, conductivity, pH and total microbes were respectively 0.60 – 44.90 ppb; 0.086 – 0.982 uS/cm;, 6.30 – 6.90; and <1 CFU/mL. Based on these results, the quality of PT Forsta Kalmedic Global's purified water produced by the machine in August – December 2022 has met specifications.