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Manufacturing White Papers

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16-30 of 167 results
Enhanced Sampling and Calibration Procedures for the Analysis of Residual Oxygen in Nitrogen Purged Pharmaceutical Packaging by GC-TCD
| By Butterworth Laboratories Ltd
In recent times there has been a large increase in the type and number of products packaged using Modified Atmosphere Packaging (MAP) procedures. The majority of these processes concern the removal of oxygen from packaging systems in order to reduce oxidative degradation of the product and increase shelf life. Whilst most of the historical development of MAP took place within the food industry, over the last 20 years there has been a large growth in its application within the pharmaceutical sector.
Production & Manufacturing > Manufacturing > White Papers
Tip Speed - Establishing Optimal Blending Speed
| By Custom Powder Systems
Tip speed (angular velocity) is a constant that can be used to establish an initial blending speed for a given bin geometry. The blender speed may need to be adjusted upon further testing but is a good starting point. The tip radius is the distance perpendicular to the blender rotational center measured to the furthest top bin corner.
Production & Manufacturing > Manufacturing > White Papers
Blender Type Comparison Pedestal Blender (PB) vs. Column Blender (CB)
| By Custom Powder Systems
A pedestal blender is a single purpose machine that can only blend. A column blender has the additional capability a lifting axis and slew (placing) axis that offers the additional capabilities.
Production & Manufacturing > Manufacturing > White Papers
Custom Powder Systems Announces Dramatic Yield Increase Through use of Anti-Segregation Technologies
| By Custom Powder Systems
"Our material handling process was very inefficient and we were lucky to yield 50% in-spec product" says the Director of a major generic pharmaceutical company, "and the handling labor was extensive. I can't even begin to tell you how frustrating it was." The Director is discussing the problem his company had with manufacturing one of its key products.
Production & Manufacturing > Manufacturing > White Papers
Truly Parallel - Cell Culture
| By Eppendorf
DASGIP® Bioreactor Systems for Cell Culture Applications.
Production & Manufacturing > Manufacturing > White Papers
Product Brochure: Most Compact
| By Eppendorf
DASbox® Mini Bioreactor System for Cell Culture and Microbiology.
Production & Manufacturing > Manufacturing > White Papers
Evaluation of the BioFlo® 320 Process Capabilities
| By Eppendorf
This poster characterizes the capabilities of the BioFlo320 in terms of key process parameters including oxygen transfer rate (OTR), volumetric mass transfer coecient (kLa), tip speed, mixing time, and water consumption. These data enable quantitative analyses of bioprocess engineering parameters, thus allowing potential users to gain insight into the system’s cell culture and fermentation capabilities.
Production & Manufacturing > Manufacturing > White Papers
Taking the Strain
| By Eppendorf
Today, the rapidly expanding demand for vaccine products for viral diseases such as rabies has necessitated the development of more sophisticated production techniques based around cell culture systems. This article reviews vaccine production strategies, with a focus on rabies, looking specifically at the use of the Vero cell line - used worldwide and approved by the US Food and Drug Administration - as well as media technology and the bioreactor options available.
Production & Manufacturing > Manufacturing > White Papers
Growing Potential: mAb Production With Fibra-Cel
| By Eppendorf
The market for monoclonal antibodies continues to grow steadily, but there are still bottlenecks in the development of new products, including long development times mostly due to R&D. Advanced bioprocess equipment that meets the specific demands of mAb-producing hybridoma can accelerate design and production, and reduce overall development costs along the way.
Production & Manufacturing > Manufacturing > White Papers
DoE Bioprocess Development
| By Eppendorf
Eppendorf DASware is the effective route to design of experiments (DoE) in early-stage bioprocess development. Claudia M Huether-Franken and Sebastian Kleebank explain how the design software applies DoE to DASGIP parallel bioreactor systems.
Production & Manufacturing > Manufacturing > White Papers
Amino Acid Analysis in Pharmaceuticals
| By Butterworth Laboratories Ltd
The European Pharmacopeia (Ph Eur) is moving away from the historical Thin Layer Chromatography technique (TLC) for the determination of Ninhydrin-positive substances, to more specific and sensitive methods utilising Liquid Chromatography (LC) or Amino Acid Analysers. This paper will explore the history of the test, the benefits of the change and considerations for validation of the LC approach to analysis.
Production & Manufacturing > Manufacturing > White Papers
Enhanced Residual Solvents Analysis: A Practical Approach to Sampling, Transport, Storage and Analysis.
| By Butterworth Laboratories Ltd
Residual solvents are organic volatile chemicals used or produced in the manufacture of active pharmaceutical ingredients (API), excipients or drug products, which remain in the material at the end of the manufacturing process. Their control is important in limiting exposure and guidelines exist to maintain patient safety, not just to satisfy competent authorities. It is a requirement that all pharmaceutical substances comply with ICH limits even if not required by individual monographs or if no compendial monograph exists.
Production & Manufacturing > Manufacturing > White Papers
Elemental Impurity Analysis in Pharmaceuticals
| By Butterworth Laboratories Ltd
A method to identify the presence of heavy metals in pharmaceuticals was introduced in the United States Pharmacopoeia more than 100 years ago. Today pharmaceutical companies are still using essentially the same method, the USP <231> Heavy Metals Limit Test. This paper will give an overview of the current method limitations, considerations for the new methodology and the risk-based assessments being carried out by manufacturers.
Production & Manufacturing > Manufacturing > White Papers
16-30 of 167 results