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"Covering aseptic technique and how to prepare sterile products, this book ensures safety, accuracy, and correctness of medications. Reflecting American Society of Health System Pharmacists (ASHP) competencies, this book provides principles and guidelines, laboratory exercises, and hands-on practice with actual institutional orders. Written by expert pharmacy technician educator, this book also provides checklists that map to ASHP competencies."

"Produk injeksi steril membutuhkan kebersihan dan sterilisasi yang tinggi agar keamanan dan efektivitas produk yang dihasilkan juga terjamin dengan tetap memenuhi standar Good Manufacturing Practice (GMP). Proses pembersihan peralatan produksi dapat dilakukan dengan metode cleaning in place (CIP) dan sterilization in place (SIP) yang penerapannya tanpa harus melepas ataupun memindahkan peralatan produksi. Pada proses akhir pembersihan tangki mixing, yaitu pengeringan, PT CKD OTTO Pharmaceuticals menggunakan gas nitrogen sebagai pengering yang membutuhkan biaya lebih tinggi karena penyimpanan gas nitrogen sendiri harus dalam tekanan tinggi, menggunakan tangki khusus. Clean air sterile dapat dipertimbangkan untuk digunakan sebagai pengganti gas nitrogen karena lebih cost effective, lebih aman untuk personil dan lingkungan. Dari hasil pengkajian terkait penggantian gas nitrogen menjadi clean air sterile untuk proses pengeringan pada proses Cleaning in Place (CIP) – Sterilization in Place (SIP) didapatkan bahwa penggantian gas nitrogen menjadi clean air sterile dapat dilakukan dengan penambahan selang penghubung antara selang compressed air dengan selang nitrogen, beserta penambahan katup pada masing-masing selang penghubung dan selang nitrogen; penggantian gas ini juga relatif aman dalam pembersihan dan sterilisasi permukaan interior tangki mixing, serta seluruh risiko yang mungkin terjadi dapat dikendalikan oleh sistem yang ada; serta dapat dilakukan penggantian apabila memenuhi parameter dari uji keberterimaan, yaitu memenuhi uji inspeksi visual setelah proses CIP-SIP.

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Sterile injection products require high cleanliness and sterilization to ensure the safety and effectiveness of the resulting products while maintaining Good Manufacturing Practice (GMP) standards. The cleaning of production equipment can be achieved using the cleaning in place (CIP) and sterilization in place (SIP) methods, which can be applied without the need to disassemble or relocate the production equipment. In the final stage of cleaning the mixing tank, which is drying, PT CKD OTTO Pharmaceuticals employs nitrogen gas as a drying agent, incurring higher costs due to the need for high-pressure nitrogen gas storage in specialized tanks. The consideration of using clean sterile air as a replacement for nitrogen gas is deemed more cost-effective and safer for personnel and the environment. The assessment regarding the replacement of nitrogen gas with clean sterile air for the drying process in the Cleaning in Place (CIP) – Sterilization in Place (SIP) process revealed that this replacement can be achieved by adding a connecting hose between the compressed air and nitrogen hoses, along with the addition of valves to each connecting hose and the nitrogen hose. This gas replacement method is also relatively safe for cleaning and sterilizing the interior surfaces of the mixing tank, and any potential risks can be controlled by the existing system. Additionally, the replacement can proceed if it meets the acceptance criteria parameters, including passing a visual inspection after the CIP-SIP process.

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"Industri farmasi merupakan suatu badan usaha yang memiliki izin sesuai dengan ketentuan peraturan perundang-undangan yang melakukan kegiatan pembuatan obat atau bahan obat. Suatu industri farmasi yang memproduksi produk sediaan steril perlu dibuat dengan persyaratan khusus yang bertujuan untuk memperkecil risiko kontaminasi mikroba, partikulat dan pirogen, Dimana hal ini dapat dipengaruhi dari keterampilan, pelatihan dan sikap personel yang terlibat. Oleh karena itu dibutuhkan sebuah sistem digitalisasi yang bertujuan untuk melakukan pemantauan jumlah sterilisasi baju steril. Metode yang digunakan yaitu menggunakan sebuah aplikasi yang dibuat dalam bentuk web base. Dari hasil penelitian bahwa aplikasi yang digunakan sudah baik akan tetapi perlu adanya perbaikan dalam pengaturan notifikasi.

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The pharmaceutical industry is a business entity that has a permit in accordance with the provisions of laws and regulations which carries out activities in the manufacture of medicines or medical substances. A pharmaceutical industri that produces sterile dosage products needs to be made with special requirements aimed at minimizing the risk of microbial, particulate and pyrogen contamination, where this can be influenced by the skills, training and attitudes of the personnel involved. Therefore, a digitalization system is needed which aims to monitor the number of sterilizations of sterile clothing. The method used is using an applicatipn created in the form of a web base. From the research results, the application used is good, but there needs to be improvements in the notification settings.

 

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"Apoteker merupakan profesional kesehatan lulusan sarjana farmasi yang telah lulus ujian kompetensi apoteker dan mengucap sumpah jabatan apoteker. Seorang calon apoteker harus mempunyai keahlian dalam melakukan praktik kefarmasian di fasilitas pelayanan kefarmasian. Oleh karena itu, calon apoteker diharuskan melakukan praktik profesi sebagai bentuk memperoleh pengalaman dan kompetensi untuk melakukan praktik kefarmasian sebagai apoteker profesional. Praktik Kerja Profesi Apoteker dilaksanakan di Rumah Sakit Universitas Indonesia selama periode bulan Maret – April 2022 dan Apotek Kimia Farma 352 Margonda selama periode bulan Mei 2022. Calon apoteker diharapkan memperoleh pengalaman, ilmu, dan keterampilan yang dapat bermanfaat dikemudian hari dalam menjadi profesi apoteker.

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Pharmacists are health professionals who have graduated from pharmacy degrees who have passed the pharmacist competency exam and take the pharmacist's oath of office. A prospective pharmacist must have expertise in practicing pharmacy in pharmacy service facilities. Therefore, prospective pharmacists are required to practice professionally as a form of gaining experience and competence to practice pharmacy as a professional pharmacist. The Pharmacist Professional Work Practice is held at the University of Indonesia Hospital during the period March – April 2022 and Kimia Farma 352 Margonda Pharmacy during the May 2022 period. Prospective pharmacists are expected to gain experience, knowledge, and skills that can be useful in the future in becoming a pharmacist profession."

"Pharmaceutical manufacture is very exacting, for example, drugs must be uniform in size, shape, efficacy, bioavailability, and safety. The presence of different polymorphs in drug production is a serious problem, since different polymorphs differ in bioavailability, solubility, dissolution rate, chemical and physical stability, melting point, color, filterability, density, and flow properties. Fine particles in medicine and pharmacy discusses particle size, shape, and composition and how they determine the choice of polymorph of a drug."

"SIMONA (Sistem Informasi Monitoring dan Pembinaan Fasilitas Pelayanan Kefarmasian) merupakan sistem monitoring yang digunakan untuk mengawasi dan membina fasilitas pelayanan kefarmasian, termasuk apotek. SIMONA membantu penyedia layanan kefarmasian untuk menilai kesesuaian dirinya terhadap standar pelayanan kefarmasian yang berlaku. Pada laporan ini dilakukan pembuatan laporan pelayanan farmasi klinis Apotek Roxy Poltangan periode Desember 2022. Laporan ini dibuat dengan menginput data laporan pelayanan kefarmasian bulan Desember 2022 Apotek Roxy Poltangan ke dalam sistem SIMONA. Hasil laporan pelayanan kefarmasian menunjukan bahwa telah dilakukan sebanyak 29 kali pengkajian dan pelayanan resep, 29 kali pemberian pelayanan informasi obat, 13 kali konseling, dan belum dilakukan telefarmasi. Hasil ini menunjukan bahwa Apotek Roxy Poltangan telah melakukan pelayanan kefarmasian yang sesuai dengan standar yang berlaku.

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SIMONA (Sistem Informasi Monitoring dan Pembinaan Fasilitas Pelayanan Kefarmasian) is a monitoring system used to supervise and develop pharmaceutical service facilities, including pharmacies. SIMONA helps pharmaceutical service providers to assess their conformity with the applicable pharmaceutical service standards. In this study, Report of Clinical Pharmacy Service at Roxy Pharmacy Poltangan branch on December 2022 was prepared. This report was prepared by inputting data for the December 2022 pharmaceutical service report for the Roxy Pharmacy Poltangan branch into the SIMONA system. The report show that there have been 29 assessments and prescription services, 29 times providing drug information services, 13 times counseling, and tele-pharmacy has not been performed. These results indicate that the Roxy Pharmacy Poltangan branch has provided pharmaceutical services in accordance with applicable standards.

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