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"Sistem tata udara adalah suatu sistem yang mengondisikan lingkungan melalui pengendalian suhu, kelembaban, arah pergerakanudara, pengendalian partikel serta pembuangan kontaminan yang ada di udara. Sistem tata udara juga dapat memberikan perlindungan terhadap lingkungan dimana terdapat bahan berbahaya melalui pengaturan sistem pembuangan udara yang efektif dan aman dari bahan tersebut. Oleh karena itu, sistem tata udara perlu didesain, dibuat, di- commissioning, dikualifikasi, dioperasikan dan dirawat dengan tepat sesuai tujuan penggunaannya.

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An air conditioning system is a system that condition the environment by controlling temperature, humidity, direction of air movement, controlling particles and removing contaminants in the air. The air conditioning system can also provide protection against environment where hazardous materials are present by setting up an effective and safe air removal system for these materials. Therefore, air conditioning systems need to be designed, manufactured, commissioned, qualified, operated and maintained appropriately according to their intended use."

"Kualifikasi kinerja bertujuan untuk memverifikasi bahwa fasilitas, sistem dan peralatan yang telah terpasang dan difungsikan, bekerja secara efektif serta memberikan hasil yang konsisten. Dalam aktivitasnya, industri farmasi wajib menerapkan program kontrol, kualifikasi, dan validasi pada setiap aspek yang dapat berpengaruh terhadap kegiatan produksi dan mutu obat yang dihasilkan termasuk pada sarana penunjang kritis. Adapun salah satu sarana penunjang kritis di industri farmasi yaitu Sistem Tata Udara (HVAC). Laporan ini berisi tentang metode kualifikasi kinerja sistem HVAC terhadap parameter kritis yang dapat mempengaruhi kualitas produk selama proses produksi di Ruang Produksi Steril Non-Cephalosporin PT. Mahakam Beta Farma.

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Performance qualification aims to verify that facilities, systems and equipment that have been installed and functioned, work effectively and provide consistent results. In its activities, the pharmaceutical industry is required to implement control, qualification and validation programs in every aspect that can affect production activities and the quality of drugs produced, including critical supporting facilities. One of the critical supporting facilities in the pharmaceutical industry is the Air Conditioning System (HVAC). This report contains the method of performance qualification of the HVAC system for critical parameters that can affect product quality during the production process in the Non-Cephalosporin Sterile Production Room of PT Mahakam Beta Farma."

"Sistem tata udara memiliki peran penting dalam industri farmasi untuk memberikan perlindungan terhadap lingkungan pembuatan produk, memastikan produksi obat yang bermutu serta memberikan lingkungan kerja yang nyaman bagi personil. Tujuan penyusunan tugas khusus selama Praktek Kerja Profesi Apoteker di PT Mahakam Beta Farma yakni untuk menganalisis kesesuaian parameter kualifikasi kinerja sistem HVAC di area ruang produksi steril NonCephalosphorin sesuai peraturan CPOB. Penyusunan tugas khusus ini menggunakan metode dengan mengunggakan data performance qualification sistem heating, ventilation, and air conditioning ruang produksi steril NonCephalosporin periode 2022, selanjutnya di lakukan kesimpulan analisis sesuai spesifikasi dan kualifikasi perusahaan PT. Mahakam Beta Farma. Sehingga didapatkan kesimpulan bahwa proses kualifikasi PQ HVAC yang telah dilakukan, dapat disimpulkan bahwa ruang produksi steril NonCephalosporin memenuhi persyaratan spesifikasi dan kualifikasi yang telah ditetapkan oleh departemen Quality Assurance PT. Mahakam Beta Farma.

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Air conditioning systems have an important role in the pharmaceutical industry to protect the product manufacturing environment, ensure the production of quality drugs and provide a comfortable working environment for personnel. The purpose of preparing special assignments during the Pharmacist Professional Work Practice at PT Mahakam Beta Farma is to analyze the suitability of the HVAC system performance qualification parameters in the non-Cephalosphorin sterile production room area according to GMP regulations. The preparation of this special task uses a method by leaving data on performance qualification systems for heating, ventilation, and air conditioning in the non-Cephalosporin sterile production room for the 2022 period. Mahakam Beta Farma. So it can be concluded that the PQ HVAC qualification process that has been carried out, it can be concluded that the NonCephalosporin sterile production room meets the specification and qualification requirements set by the Quality Assurance department of PT. Mahakam Beta Farma."

"Industri Farmasi merupakan suatu perusahaan yang berbentuk badan hukum dan memiliki izin untuk melakukan kegiatan produksi atau pemanfaatan sumber daya produksi, penyaluran obat, bahan obat, dan fitofarmaka, melaksanakan pendidikan dan pelatihan, dan/atau penelitian dan pengembangan (Kemenkes RI, 2018). Semua proses yang dilakukan oleh suatu Industri Farmasi harus memenuhi persyaratan serta berpedoman pada Cara Pembuatan Obat yang Baik (CPOB) (BPOM RI, 2018). CPOB mencakup seluruh aspek produksi salah satunya yaitu kualifikasi dan validasi. PT. Sydna Farma merupakan salah satu industri farmasi yang telah rutin melaksanakan proses kualifikasi dan validasi diantaranya yaitu kualifikasi kinerja Heating Ventilation and Air Conditioner (HVAC). Sistem HVAC merupakan sistem tata udara yang digunakan untuk mengontrol kondisi atau suhu lingkungan pada suatu ruangan atau area tertutup, baik itu bangunan, gudang, ataupun kendaraan komersial (WHO, 2018). Pelaksanaan proses rekualifikasi di PT. Sydna Farma dilakukan oleh departemen bagian validasi yang dibawahi langsung oleh bagian Quality Assurance (QA). Berdasarkan pengamatan yang telah dilakukan selama kegiatan PKPA di PT. Sydna Farma, dapat disimpulkan bahwa proses rekualifikasi kinerja HVAC di ruang tableting estrogen telah dilakukan mengikuti protokol yang berlaku di PT. Sydna Farma dan telah sesuai dengan ketentuan Cara Pembuatan Obat yang Baik (CPOB).

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The Pharmaceutical Industry is a company that is a legal entity and has a permit to carry out production activities or utilize production resources, distribute drugs, medicinal ingredients, and phytopharmaca, carry out education and training, and/or research and development (Kemenkes RI, 2018). All processes carried out by a pharmaceutical industry must meet the requirements and be guided by Good Drug Manufacturing Practices (GMP) (BPOM RI, 2018). GMP covers all aspects of production, one of which is qualification and validation. PT. Sydna Farma is one of the pharmaceutical industries that has routinely carried out a qualification and validation process including the Heating Ventilation and Air Conditioner (HVAC) performance qualification. The HVAC system is an air conditioning system that is used to control environmental conditions or temperature in a room or closed area, be it a building, warehouse or commercial vehicle (WHO, 2018). Implementation of the requalification process at PT. Sydna Farma is carried out by the validation department which is directly supervised by the Quality Assurance (QA) section. Based on the observations that have been made, it can be concluded that the HVAC performance requalification process in the estrogen tableting room has been carried out following the applicable protocol at PT. Sydna Farma and complies with the provisions of Good Drug Manufacturing Practices (GMP).

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"Smart building dibangun dengan konsep kemudahan kenyamanan kesehatan dan efisiensi energi Perbedaan smart building dengan bangunan lainnya adalah bangunan ini memiliki BMS building management system yang merupakan otak dari seluruh bangunan Sistem HVAC mengkonsumsi energi lebih dari 50 dari total konsumsi energi bangunan Penelitian ini bertujuan mengidentifikasi sistem pengudaraan yang perlu diterapkan pada bangunan sehingga menciptakan smart building dan mengetahui nilai LCC nya dibandingkan dengan sistem pengudaraan bangunan konvensional menggunakan pendekatan value engineering dengan analisis paired comparison dan analisis life cycle cost Sistem pengudaraan yang akan diterapkan sesuai dengan sistem pengudaraan sebuah bangunan di California Amerika Serikat yaitu dengan tambahan sistem kontrol dan pemilihan komponen yang lebih hemat energi nyaman dan sehat Nilai LCC dilihat dari NPV nya lebih kecil 14 05 dan B CR SB sebesar 0 501 yang lebih baik dibandingkan bangunan konvensional yang nilai B CR nya 2.51.

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Smart building built with the concept of simplicity user comfort health and energy efficient. The difference between smart building and the other building is that smart building has BMS building management system which is the brain of the building HVAC system consumes energy more than 50 from total building energy consumption. This research has purposes to identify the HVAC system that should be applied on buildings in order create smear building and to find out the LCC compared to the HVAC system on conventional building using the value engineering approach with paired comparison analysis and the LCCA HVAC system that will be applied according to HVAC system of a building in California USA is added with control system and energy efficient comfort and healthy components. The LCC value according to the NPV has to be 14 05 smaller and B CR of SB is 0 501 which is better than the value of conventional building whose B CR value is 2.51"

"Provides a complete, state-of-the-art source on automotive heating, ventilation, and air conditioning systems.Correlated to NATEF and ASE tasks, the text focuses on the generic theory that underlies the operation, diagnosis, and repair of the units and subassemblies found in the many makes and types of vehicles students will likely encounter on the job."