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Modular Facility – a Lean Case Study
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Modular Facility – a Lean Case Study
It takes innovation and collaboration to accelerate the design and construction process to bring manufacturing facilities online to produce lifesaving vaccines as quickly as possible.
WFI: A Cost Review
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WFI: A Cost Review
When it comes to producing Water for Injection (WFI), capital, operating, and maintenance costs vary and some are assumed to be more economical than others. See what we uncovered in this cost analysis of four WFI systems including alternative WFI systems versus distillation technologies.
Concept study of remote handling operations in containment &/or aseptic application
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Concept study of remote handling operations in containment &/or aseptic application
How robotic technology contributes to ensure aseptic production and mitigate risks in manufacturing processes Pharmaceuticals that get contaminated can cause significant health problems after distribution and use. The evolution towards a safe and reliable industry, together with the optimization of...
Water for Injection (WFI) Risk, Reliability, and Sustainability
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Water for Injection (WFI) Risk, Reliability, and Sustainability
As a manufacturer of pharmaceutical or biologic drug products, you want to evaluate all of the issues surrounding your design choice for critical water production. While membrane-based production of Water for Injection (WFI) continues to be at the forefront of discussion, understanding the risk,...
How to Ensure a Holistic Process Characterization in Biotech & Pharma
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How to Ensure a Holistic Process Characterization in Biotech & Pharma
Constant, reliable product quality is a must for pharmaceutical and biopharmaceutical manufacturing. Regulatory authorities require drug manufacturers to consistently deliver product quality through validated processes in order to achieve product approval. Process characterization is a central...
In-Line Control of CO2 Accumulation for Improved Cell Culture Processes
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In-Line Control of CO2 Accumulation for Improved Cell Culture Processes
The importance and value of measuring and regulating dissolved CO2 levels in cell culture is growing in acceptance. Atline and off-line CO2 measurement does not allow the necessary real-time monitoring that would allow process improvements. Continuous measurements directly in the bioreactor with an...
Granulation Technology Scale up
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Granulation Technology Scale up
Granulation is one of the most important unit operations in pharmaceutical solid dosage manufacturing. Despite already having been in use for many years, the choice of the correct technology can still cause headaches in some situations. Consequently, for many operators this means running at less...
Airflow Visualization: The Most Misunderstood & Underappreciated Cleanroom Test
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Airflow Visualization: The Most Misunderstood & Underappreciated Cleanroom Test
Airflow Visualization (Smoke Studies): The Most Misunderstood and Underappreciated Cleanroom Test Airflow Visualization studies (AKA Smoke Studies) are used to evaluate air patterns in medical product cleanrooms and barrier systems (RABS, Isolators, pass-throughs and airlocks) that support...
Digital Solutions for Efficient Maintenance in Industry
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Digital Solutions for Efficient Maintenance in Industry
How pharmaceutical companies benefit from digitization Efficient, holistic digitization concepts make a decisive contribution to optimizing the value creation process of companies. The pharmaceutical industry is also increasingly recognizing the importance of adapted and effective maintenance to...
Bringing the Freezing of Biopharmaceuticals in From the Cold
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Bringing the Freezing of Biopharmaceuticals in From the Cold
Integrated Solutions To Minimize Risk and Preserve Product Quality Introduction Do we dare treat drug substance freezing as an isolated process? Or should freezing be integrated with bulk filling, storage, shipping, thawing and fill-finish operations to deliver a multi-site end-to-end process that...
HEPA Filters - Key requirements for the pharmaceutical industry
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HEPA Filters - Key requirements for the pharmaceutical industry
What Is a HEPA Filter? HEPA is the acronym for “High Efficiency Particulate Air” or “High Efficiency Particulate Arrestance”. The HEPA filter is a type of mechanical filter. It works by providing a barrier in the form of a very dense filter media which is made up of very fine fibres that trap...
IT/OT Convergence: The Path to Pharma 4.0™
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IT/OT Convergence: The Path to Pharma 4.0™
To understand the modern life sciences manufacturing process, one must understand how the industry has transformed since the beginning of the “Industrial Revolution.”
AI in Tomorrow’s Pharma & Biotech Industry
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AI in Tomorrow’s Pharma & Biotech Industry
Artificial Intelligence (AI) is currently revolutionizing the healthcare system, in which AI-based software is increasingly becoming a part of medical procedures. AI will also play a key role in pharmaceutical manufacturing, helping companies to optimize processes. However, in pharma production,...