pharmaceutical manufacturer Articles
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Single Use in Pharmaceutical Manufacturing
In order to ensure the full manufacturing process is continuously and reliably monitored, single use technologies are emerging as a vital tool. Those validated for long term, 2-hour sampling in critical environments at 25 LPM capture the entire manufacturing ...
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Alcohol scrubbing pharmaceutical manufacturing 105
A New York based pharmaceutical manufacturer’s pill coating operation required ventilation to keep the isopropanol levels in the dryers from reaching LEL concentrations. Due to the high volatility of the alcohol, it was necessary to use a once through with water to absorb the hot, high concentrations of isopropanol. A vertical tray scrubber (Model VTS) was utilized in order to optimize the ...
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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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Rapid Viable Monitoring and Regulations for Pharmaceutical Manufacturers
Pharmacopoeias worldwide have promoted rapid or alternative microbiological methods for almost 20 years. All now have chapters in which the validation of alternative methods is described (e.g. United States Pharmacopeia (USP), or European Pharmacopoeia (EP) 5.1.6), and these chapters continue to evolve with frequent updates. Regulatory bodies have created specific pathways to facilitate the use ...
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Pharmaceuticals Manufacturing Industry - Pollution Prevention Guidelines
Introduction Pollution Prevention Guidelines to provide technical advice and guidance to staff and consultants involved in pollution-related projects. The guidelines represent state-of-the-art thinking on how to reduce pollution emissions from the production process. In many cases, the guidelines provide numerical targets for reducing pollution, as well as maximum emissions ...
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Pharmaceutical and Medical Sector Waste Review Service
Pharmaceutical manufacturing plants generate a variety of waste streams throughout the production, supply and organisational processes. While the day-to-day activities are similar from one plant to the next, the actual processes used in pharmaceutical manufacturing vary widely. The pharmaceutical industry is highly competitive and many organisations are often unwilling to reveal details that ...
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Assessing FDA's risk methodology at pharmaceutical manufacturing sites
This research analyses the US Food and Drug Administration's (FDA's) risk methodology used for inspecting pharmaceutical manufacturing sites. It reviews the procedures, regulations, and violations specified in FDA warning letters (WLs). In particular it focuses on the time period between 2004-2009, as the FDA transitioned and formalised this new approach to site inspections. One of the principal ...
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Pharmaceutical Companies Rely on Nitrogen
Pharmaceutical firms research, develop, and manufacture over-the-counter and prescription drugs and medicines. Usage of these drugs includes, but is not limited to, vaccinations, treatment for chronic conditions, and pain management. To protect the health and well-being of the public, the pharmaceutical industry is one of the most highly regulated industries. For instance, in the United States, ...
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Catching Up with GMP Requirements
This two-part blog series discusses current good manufacturing practices (GMPs) and how they can be applied to a continuous environmental monitoring system installed within a pharmaceutical manufacturing facility. Quality and Production teams can then establish new environmental monitoring understandings and harmonize with ...
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Electronic Data in Pharmaceutical Manufacturing: Benefits of Paperless Reporting (Series Part 2 of 6)
Benefits of Paperless Reporting in Pharmaceutical Manufacturing Paperless pharmaceutical manufacturing sites are a relatively new concept. In 2015, ISO updated their Standard 14644 to include data integrity issues that allowed manufacturers to use validated systems to electronically store, analyze and report their product and process data. This was a great benefit to the industry as it gave ...
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A 5-minute Screening Method for Incoming Raw Materials in Pharmaceutical Manufacturing
Normal quality control procedures involve accepting a “lot” of a raw material from a supplier and then performing a series of tests to determine if the material is suitable for use in a manufacturing process. For the drug manufacturing industry, as well as many others, this is both a critical and time-consuming (and occasionally costly) step in the process. If the sample is not ...
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Sampling Guidance for Pharmaceutical Manufacturers from the Annex 1 2017 Draft
Sampling should be done as close as possible to the critical area in Grade A environments, but without posing any risk to the process and sampling itself. To do both has been a long-standing dilemma, and often requires a specialized approach using technologies such as single use. The frequency of viable sampling has received an almost revolutionary renewal in the Annex 1 draft. Chapter 9.25 ...
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Tendering and decision–making: a case on pharmaceutical products
In order to contain expenditures for pharmaceuticals, the latest healthcare reforms have focused on decentralising German pharmaceutical market. Health insurance funds are now able to tender the products and subsequently conclude rebate contracts with one or more companies. Considering the enormous bargaining power of health insurance funds, pharmaceutical manufacturers, in particular companies ...
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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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Meco`s Masterfit System Selected for Nexus Pharmaceutical Facility
Introduction “Our priority is to provide our customers with the high purity water and steam that is critical to the development and manufacturing of life-saving medications now and for future generations.” —George Gsell, MECO President Nexus Pharmaceuticals, maker of difficult-to-manufacture, high quality, FDA-approved specialty and generic drugs, is opening a $250 million, ...
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Two approaches to effective ventilation system design for the biomedical device and pharmaceutical industries
This paper provides two alternative solutions to the difficult task of providing adequate ventilation to operations found in the biomedical device and pharmaceutical manufacturing industries. The first approach involves a two-tier strategy that includes an isolation chamber and an appropriately designed local exhaust hood. The second approach involves the design of modular, walk-in hood. ...
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Electronic Data in Pharmaceutical Manufacturing: Data Integrity (Series Part 1 of 6)
Data Integrity - Data Storage & Retrieval Data integrity means data that is accurate, complete and repeatable, which in turn ensures the product’s quality and public safety. Compliance is the goal of improving process control, product quality and Regulator confidence while reducing product defects and costs. Both of these concepts work hand-in-hand and apply to multiple areas of the ...
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A risk based approach to manage active pharmaceutical ingredients in manufacturing effluent
This publication describes guidance intended to assist pharmaceutical manufacturers in assessing, mitigating and managing the potential environmental impacts of active pharmaceutical ingredients (APIs) in wastewater from manufacturing operations, including those from external suppliers. The tools in this publication are not a substitute for compliance with local regulatory requirements, but ...
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Oxygen for Covid-19 Vaccines and Patient Care
Interview With Horst Nowosad, Sales and Project Engineer at Inmatec Medical oxygen is used in emergency care and vaccine production. With their own O2 generation, hospitals and pharmaceutical manufacturers secure supplies and reduce costs. Mr. Nowosad, Inmatec GaseTechnologie is a leading manufacturer of oxygen and nitrogen generators. What developments do you see in the area of oxygen ...
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Exhibition in Shanghai – Aquatech 2018
This week is the largest water exhibition in the world — Aquatech China 2018. SnowPure is part of this, and you can find us in Hall 8, Floor 1, Stand H738. (8.1.H738). Electropure China is co-located with Shanghai Yuan Mai Environmental Technology this year. We will be exhibiting the wide range of electrodeionization products produced, aimed at Chinese power plants, pharmaceutical ...
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