pharmaceutical processes Articles
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Guidelines For Cleaning Pharmaceutical Processing Equipment
Cleaning pharmaceutical processing equipment is challenging. Cleaning methods, soils present, type of manufacturing equipment, surfaces cleaned, choice of cleaning detergent and temperature should all be considered when setting up a cleaning procedure. Cleaning validation methods are required. The entire cleaning process must be standardized and documented according to the FDA’s cGMP ...
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Microbial Survival in Compressed Gases Under Fast Decompression to Normal Atmospheric Conditions
Introduction and Goal Compressed gases are broadly used in medicinal production facilities. A variety of different gases can be introduced into the process at various stages of a product’s manufacture for different reasons. Compressed gases such as air, nitrogen, and carbon dioxide are regularly used in cleanrooms and are frequently employed in purging or overlaying. The cleanliness of ...
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A New Challenge for Quality Experts - the Data Quality Concept
Abstract The role of quality systems in pharmaceutical organizations has grown faster than any other function during the last 15 years. During this period, a small group dedicated to traditional Compliance grew and expanded to include Quality Experts in areas such as validation, product release, operations, sterility assurance, and other specialized functions. Creating a deeper quality connection ...
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Clarification for vaccines
Clarification for vaccines – the economic and efficient removal of cell debris and negatively charged molecules with FILTRODISC BIO SD and FILTRODISC R2U depth filter modules. The purification of vaccines is a critical step during their complex production process. Cells and cell debris, as well as unwanted contaminants such as host cell proteins (HCPs) and nucleic acids need to be removed, ...
By Filtrox AG
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Developing knowledge management – what makes the success?
In this paper we develop a list of critical factors for knowledge management (KM), using different theoretical frameworks. We identified four elements which were common to most models: management promotion, infrastructure, strategy and evaluation. Conducting four case studies from firms in the chemical industry allowed us to compare our factors with empirical data. We found that the involvement ...
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Capability portfolio for the initial phase of internationalisation of emerging economy firms: a study in the Indian pharmaceutical industry
This paper analyses the internationalisation experiences of seven firms in the Indian pharmaceutical industry and identifies the portfolio of capabilities required in the initial phase of internationalisation. It traces the priorities, simultaneity and sequence in the capability development process and identifies the differences between early and late internationalisers. It notes that studies so ...
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Ownership, technological intensities, and economic performance in South Africa
This paper examines statistical differences and determinants of labour productivity, and export, skill and technological intensities between foreign and local auto parts, electronics, food, pharmaceutical and garment firms in South Africa. Foreign firms enjoyed higher labour productivity, and export, overall technology, process and R&D intensities than local firms in pharmaceuticals, and export, ...
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Issues Brought Up During BC-CM Producers Group Meeting Featured By Inside EPA Article
On January 13, 2017, slides from the B&C® Consortia Management’s (BC-CM) NMP Producers Group Meeting with the Office of Management and Budget were discussed in the Inside EPA article “Chemical Makers Cite TSCA Listing In Call For EPA To Drop NMP Proposal.” But representatives from Bergeson & Campbell on behalf of NMP producers in a Dec. 5 meeting with EPA and OMB ...
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The changing autarky pharmaceutical R&D process: causes and consequences of growing R&D collaboration in Japanese firms
This paper analyses the changing R&D process at Japanese pharmaceutical companies, based on a questionnaire survey as well as structured interviews at large Japanese pharmaceutical companies. Japanese pharmaceutical companies have recently engaged in active R&D collaborations with other firms and universities. This paper identifies the factors underlying this trend, finding that all three factors ...
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Pharmaceutical Monitoring Requirements for Transport and Delivery
Temperature and humidity monitoring play a major role in ensuring safety, quality, and potency in the pharmaceutical processing chain. However, an aspect that is sometimes understated is the importance of continued monitoring during transport and delivery. Regardless of the means of transportation, Annex 9 of the WHO Technical Report Series requires time and temperature monitoring throughout ...
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Exploring the Benefits of ANFDs in Pharmaceutical Manufacturing
Introduction to ANFDs Digitisation and integration are hallmarks of modern manufacturing. They enable greater productivity and more sustainable processes. Yet they often require significant investment. Transitioning to new, more interconnected systems can be tedious and time-consuming. But the long-term benefits can be extraordinary. Pharmaceutical manufacturing is not immune to this ...
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Elimination of active pharmaceutical ingredients (APIs) and other problematic components from wastewater
Pharmaceuticals and their metabolites are detected on an increasing scale in the aquatic environment. The pharmaceuticals (such as drugs) mostly get into the surface and drinking water through the excretions of humans and animals; however, the wastewater of pharmaceutical production facilities can also be contaminated with active ingredients. The production of pharmaceuticals takes place in two ...
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Usage of Smart Device in the Healthcare Industry
A smart device in the 21st century is an essential tool that bridges the gap between humans no matter where they are in the world. With the constant evolution of technology, we are now able to build a connection and socialise in astonishing ways we would have never imagined decades ago. Though mobile phones are the most common smart devices that people are aware of, modern technology is ...
By Sky Labs
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Understanding API-Excipient Interactions in Pharmaceutical Formulations
Pharmaceutical formulations consist of active pharmaceutical ingredients (APIs) and excipients. Appropriate excipient selection is critical to the final quality of pharmaceutical products. When designing pharmaceutical preparations, the choice of excipients should not only consider the dosage form factors and excipient functions but also the interaction and compatibility between APIs and ...
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Leveraging Automation in Pharmacy Packaging
The pharmaceutical industry has always been at the forefront of innovation, and automation has played a vital role in driving the industry forward. With an increasing demand for pharmaceutical products, there has been a need for faster and more efficient packaging solutions on a commercial scale. Pharmacy packaging automation is an effective solution to meet this demand. Read on to explore ...
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Unleashing the Potential of Bacterial Genome Editing: A Gateway to the Future
Technological advancements and innovative research have continuously led to the discovery and development of new methodologies in the field of biological and medical sciences. One such breakthrough discovery is bacterial genome editing, which opens a new world of opportunities and challenges in the field of biotechnology and genomics. Understanding Bacterial Genome Editing Bacterial genome ...
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What Are the Cytokines?
Cytokines are a class of small molecule proteins secreted by cells that mediate and regulate immune processes, and they act in an autocrine, paracrine and endocrine manner. More than 200 types of human cytokines have been identified, which can be generally classified into interleukins, interferons, tumor necrosis factors, colony-stimulating factors, chemokines, growth factors, etc. according to ...
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Wastewater emissions treatment at pharmaceutical production plants
Wastewater is generated from production processes at pharmaceutical sites. It is vital that the basins of the wastewater treatment plants (WWTP) get covered and are not open to the atmosphere, and that the vents generated are treated safely with environmental technology for emissions ...
By TECAM
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Top 5 benefits of wastewater treatment for pharmaceutical industries
Waste waters are generated as the outcomes of various processes like chemical synthesis, fermentation, etc in a pharmaceutical industry. Hence, wastewater treatment has become mandatory for these industries to maintain the optimum quality. Moreover, such treatments are inevitable for the companies to meet the desired legal standards in pharmaceutical production. Violating such requirements can ...
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Pharmaceutical environmental control unit: Where process control drives the outcome - Case Study
A pharmaceutical company that specializes in chemical process technology solutions came to CleanroomSystems® for help maintaining a cleanroom environment for one of their compound research and development (R&D) units. More specifically, they were looking for a customized pharmaceutical environmental control unit that would control the temperature, relative humidity, pressure and ...
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