scholarly journals Validasi Proses Produksi Dektrosa Monohidrat (DMH) Farmasi pada Skala Pilot

2020 ◽  
Vol 30 (4) ◽  
Author(s):  
Sri Mulyani Suharno ◽  
Didik Sudarsono ◽  
Eriawan Rismana ◽  
Indrawati Dian Utami ◽  
Lely Khojayanti ◽  
...  

Armaceutical dextrose monohydrate (DMH) as one of the raw materials for drugs which is widely used in the manufacture of infusions and drug preparations, including BBO, which is entirely still imported. To achieve the independence of national pharmaceutical raw materials, it is important to study and develop the DMH pharmaceutical production process technology in Indonesia. In this research, the validation of the DMH pharmaceutical production process using food quality liquid glucose raw materials on a pilot-scale of 5 - 6 kg/product was carried out. The validation process has been carried out three times in all stages of the process, namely saccharification, carbon purification, resin purification, evaporation, crystallization, centrifugation, and drying. Several test parameters have been established at each stage of the process so that the repeatability of the production process and the quality of pharmaceutical DMH can be achieved. The results showed that each stage of the process played a role in improving the quality of dextrose. Product yield and weight loss of dextrose in the whole process were 50–52% and 9–10%, respectively. The results of testing the levels of dextrose (dextrose equivalent/DE), endotoxin content, pyrogen-free tests, and other parameters that have been carried out on pharmaceutical DMH products have met the quality requirements according to the Indonesian Pharmacopoeia Edition V. In conclusion, the validation results show that the bench-scale pharmaceutical DMH production process technology is developed to produce pharmaceutical DMH products with process repeatability and good quality. Abstrak Dekstrosa Monohidrat (DMH) farmasi merupakan bahan baku obat (BBO) yang banyak digunakan pada pembuatan infus dan sediaan obat serta termasuk salah satu BBO yang seluruhnya masih dimpor. Untuk mencapai kemandirian bahan baku farmasi nasional, maka pengkajian dan pengembangan teknologi proses produksi DMH farmasi menjadi penting untuk dilakukan di Indonesia. Dalam penelitian ini telah dilakukan validasi proses produksi DMH farmasi menggunakan bahan baku glukosa cair kualitas pangan pada skala pilot 5–6 kg produk/bets. Proses validasi telah dilakukan sebanyak tiga kali ulangan pada seluruh tahapan proses yaitu sakarifikasi, pemurnian dengan karbon, pemurnian dengan resin, evaporasi, kristalisasi, sentrifugasi, dan pengeringan. Beberapa parameter uji telah ditetapkan pada setiap tahapan proses agar keterulangan proses produksi dan kualitas DMH farmasi dapat tercapai. Hasil penelitian menunjukkan bahwa setiap tahapan proses berperan dalam peningkatan kualitas dekstrosa. Rendemen produk dan kehilangan berat dekstrosa pada keseluruhan proses masing-masing adalah 50–52% dan 9–10%. Hasil pengujian kadar dekstrosa (dekstrosa ekivalen/DE), kandungan endotoksin, uji bebas pirogen, dan parameter lain yang telah dilakukan terhadap produk DMH farmasi adalah sudah memenuhi persyaratan kualitas sesuai Farmakope Indonesia Edisi VI. Disimpulkan, hasil validasi menunjukkan bahwa teknologi proses produksi DMH farmasi skala pilot yang dikembangkan dapat menghasilkan produk DMH farmasi dengan keterulangan proses dan kualitas yang baik.

Author(s):  
Dries Bongaerts ◽  
Jonas De Roos ◽  
Luc De Vuyst

Lambic beers are beers produced through spontaneous fermentation and maturation in wooden barrels. The production process of lambic beers differs from the production processes of lagers and ales in process technology, environmental parameters, and the use of specific raw materials. Moreover, every lambic beer production process is unique in terms of microbiology and flavour formation because of its dependence on the spontaneous inoculation of microorganisms coming from the environmental air (contacting the open coolship and other brewery equipment) and the inner surfaces of the barrels. Several factors influence the inter- and intraspecies microbial successions during lambic beer wort fermentation and maturation and determine the final quality of the end-products. The possibility to manually acidify the wort, the presence of species-specific metabolic traits, the environmental temperature, the co-occurrence of lactic acid bacteria and acetic acid bacteria, as well as yeasts, and the quality of the wooden barrels all determine the progress and outcome of the lambic beer production process. Further alterations in quality and flavour of lambic beers can be achieved by blending practices and additional bottle re-fermentations. This results in a vast array of lambic-derived beer products (e.g., gueuze) with complex taste and aroma profiles and specific characteristics, which separates them from most other commercially available beers.


2014 ◽  
Vol 5 (2) ◽  
Author(s):  
Listiani Listiani

This research is aimed to determine the quality control system of production process in PT Industri Sandang Nusantara unit Patal Secang, measure the efectivity of quality control system by using control P-Chart and determine factors that cause defect product. This research is explorative descriptive by case study method. Data used in this research is the procedure of production process and the number of defect product. Product used in this company is  thread R30/1 UW and R 40/1 UW PT Industri Sandang Nusantara Unit Patal Secang in 24 periods of production between April – Mei 2006. Data is collected by interview, documentation, and observation. Data is analyzed by control p-chart and fish bone diagram. The conclusion of this research are: (1) The quality control system which is consists of controlling raw materials, production process and final product is appropriate with the company’s standard; (2) the number of defect product R 30/1 UW is 26.956 bale with the average 0.0167; Control P Chart shows that there are three periods which are out of control. They are in April 30, Mei 5 and 21, 2006. (3) The number of final product R 40/1 UW is 2159 bale with the average 0.0214; control p-chart shows that there are tw periods which are out of control. They are ini Mei 6 and Mei 12, 2006. (4) Factors that cause defect product are obsolete machines, employee performance, control system, and raw materials. Based on that condition, management should impove the controlling of machines, improve motivation and commitment of the employee, improve the method of inspection and control the quality of raw materials.


2018 ◽  
Vol 1 (2) ◽  
pp. 202-208
Author(s):  
Erik Bagus Prasetyo

Raw materials is a major requirement in the production process for manufacturing companies. in fulfilling the needs of raw materials for the production process, most manufacturing firms depends on suppliers. Supplier selection is an important part of manufacturing companies. From several supplier selection criteria, quality is one of the important criteria and it used in supplier assessment. Selecting suppliers based on the quality of their products will have a positive impact on manufacturing companies, such as increased profits through reduced operational costs and increased market share. In this study will compare two suppliers at manufacturing companies and choose one that has a higher capability value. The selection of suppliers is made using the yield index of Spk with a single characteristic. Supplier will be selected by comparing the yield ratio of two suppliers. Numerical calculations are performed on suppliers based on pH levels on the leather. The pH level on the leather will affect the color. A low pH may result color degradation earlier, whereas a high pH may result poor color matching.


2020 ◽  
Vol 8 (2) ◽  
pp. 103
Author(s):  
Nur Syahdi

The results showed that the SOP used was the SOP in the simplest form which only had a few activities and decision making. In the production process there are five stages carried out during the production process, namely, preparing raw materials, stirring the dough into a mixer, the process of rolling bread, the process of developing bread and the process of developing the dough ready to bake. Here the raw materials in the form of main raw materials namely wheat flour, capital in the form of owner's personal capital, machines in the form of tools used during the production process and work force are very influential during the production process because workforce is the main actor in the production of bread king. As one of the kingpin bread businesses in Samarinda, it is expected that the staff of the kingpin bread must continue to improve and maintain the quality of the production produced, that is bread kingpin and still maintain the quality of human resources namely labor. The most important thing must not be forgotten is that labor is a very very important factor of production in every production process that should be a benchmark to find out whether the system implemented has been implemented properly.


2020 ◽  
Vol 12 (18) ◽  
pp. 7491 ◽  
Author(s):  
Juan José Bullón Pérez ◽  
Araceli Queiruga-Dios ◽  
Víctor Gayoso Martínez ◽  
Ángel Martín del Rey

Traceability and monitoring of industrial processes are becoming more important to assure the value of final products. Blockchain technology emerged as part of a movement linked to criptocurrencies and the Internet of Things, providing nice-to-have features such as traceability, authenticity and security to sectors willing to use this technology. In the retail industry, blockchain offers users the possibility to monitor details about time and place of elaboration, the origin of raw materials, the quality of materials involved in the manufacturing processes, information on the people or companies that work on it, etc. It allows to control and monitor textile articles, from their production or importing initial steps, up to their acquisition by the end consumer, using the blockchain as a means of tracking and identification during the whole process. This technology can also be used by the apparel industry in general and, more specifically, for ready-to-wear clothing, for tracing suppliers and customers along the entire logistics chain. The goal of this paper is to introduce the more recent traceability schemes for the apparel industry together with the proposal of a framework for ready-to-wear clothing which allows to ensure the transparency in the supply chain, clothing authenticity, reliability and integrity, and validity of the retail final products, and of the elements that compose the whole supply chain. In order to illustrate the proposal, a case study on a women’s shirt from an apparel and fashion company, where a private and open blockchain is used for tracing the product, is included. Blockchain actors are proposed for each product stage.


2020 ◽  
Vol 8 ◽  
pp. 428-436
Author(s):  
Isna Zulfa Azmi ◽  
Oktora Yogi Sari

The increasing number of bag factories throughout Indonesia that have well-known brands and every manufacturer is required to provide products of good quality. Poor product quality will cause consumers to move to other similar products. So in the production of bags, the thing that must be considered by the company is the quality of its products. In this study the authors aim to analyze quality control in a production process and identify several factors that cause disability in the product, PT. MAG is a bag company that is demanded to control the quality of the production process. This study uses a six sigma analysis tool consisting of five steps, namely using the DMAIC method (Define, Measure, Analyze, Improve, and Control). Based on the results of the study there are three types of disabilities in the production process, including cutting, zippers and broken bag straps with an average sigma value of 2.48 with a DPMO value of 20256.92. Factors affecting the production process are human, machine, environment, equipment, raw materials, and methods. In this case the company can use the Six Sigma method because it is still in the medium category.


2020 ◽  
Vol 11 (1) ◽  
pp. 54-58
Author(s):  
Gunawan Mohammad

PT Candrabuaya Surya Semesta is a company that produces catering and bread, one of which is located in the Jepara City. Increasing competition in the catering and bread business requires companies to be able to maintain and improve their quality to retain customers. The purpose of this study is to determine the level of product quality and to determine the factors that caused the quality of a product from the company. The sweet wet bread product is a superior product that more customer interested, so in this study (research) used analysis of product quality control with P maps and seven tools of quality. There are two main defects in the production process of sweet wet bread, namely the dough does not expand and baking is not perfect. Of the two defects, the defect of the dough does not develop into a priority proposal for improvements that must be done by the company. The common factors that cause disability are method factors in the production process, equipment used, human reliability factors, and materials / raw materials used.


2020 ◽  
Vol 1 (2) ◽  
pp. 72-78
Author(s):  
Yulianto

This study aims to determine the analysis of the quality control of palm oil quality in PT. Lembah Bhakti Aceh Singkil Plantation. The function of implementing quality control is to control the quality of the initial input in the form of completion of raw materials, the production process, to the process of output of finished goods. This study uses several methods, namely filtration and titration. The average quality of palm oil at FFA levels ranges from 3.39 to 4.97 with a max.3 standard, a moisture content ranging from 0.12 to 0.3% with a max standard. 0.2%, and impurities levels ranged from 0.015-0.025% with the max standard. 0.02%. Based on the results of the study it can be concluded that the measurement of quality control that is carried out is very influential in product quality, so that it can affect the income. Where the income of a company depends on the CPO oil selling price in PMKS PT. Perkebunan Lembah Bhakti. The selling value in marketing is very dependent on the quality of the CPO.


2021 ◽  
Vol 6 (5) ◽  
pp. 175
Author(s):  
Leni Leni ◽  
Mardin Mardin ◽  
Suriana Suriana

This study aimed to determine the production process of the blacksmith industry in Togo Binongko District, Wakatobi Regency, in May 2019. The determination of the research location was determined purposively. Respondents in this study were heads of families who worked as blacksmiths in Togo Binongko District, Wakatobi Regency, with as many as 20 respondents. Data analysis uses quantitative data analysis techniques to describe the data that has been collected and present the data in tabular form so that it becomes clearer according to the conditions in the field. The results showed that the agricultural equipment produced by the smart in Togo Binongko District was made through a traditional production process while maintaining product quality. The production process starts from Tila and Tihi (sorting and cutting of iron raw materials), Kepa'a (forging), Hokomonde'a (modeling), and Soropu'a (re-burning). Blacksmith artisans can maintain the quality of the products produced by improving the production process by participating in training and using equipment that can increase production efficiency.


2021 ◽  
Vol 10 (2) ◽  
pp. 85
Author(s):  
Winona Valeria Siregar ◽  
M. Nur Ghoyatul Amin

Red snappers are fishery commodities which have high market values. Raw materials of red snappers are important elements which determine the quality of the final products. Therefore, an enhancement of raw materials quality should be conducted through quality supervision and examination when the raw materials are retrieved, stored, and about to enter production process. The aim of this fieldwork practice is to find out the raw materials quality control on red snapper freezing process in PT. Tridaya Jaya Manunggal Pasuruan, East Java. The data taken consists of primary and secondary data which are processed descriptively. Data collection techniques through observation, interviews, active participation and literature review. PT. Tridaya Jaya Manunggal has implemented quality control on production process, starting from raw materials retrieval until these raw materials become final products. The quality control of raw red snappers were done in accordance with the quality control procedures which are plan, do, check, and action. The results of implementing quality control which were executed with organoleptic examination, temperature, Total Volatile Base (TVB), microbiology, and heavy metals on raw red snappers. Raw materials which didn’t meet the required standard were rejected, and then they were processed to be second grade products.


Sign in / Sign up

Export Citation Format

Share Document