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Featured Whitepaper: Vaisala
NEW eBook: Using GAMP to Validate Monitoring System Software
Sponsored By: Vaisala
Learn how to use the GAMP methodology to validate monitoring system software. This ebook describes a 10-step process to help ensure your environmental monitoring systems align with both your QMS, and good practice as described by the ISPE. Also, learn about the category of system that best suits your qualification capabilities, and how to manage costs and risks.
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Stability Evaluation of Amorphous Solid Dispersions (ASDs) of Felodipine (FLD) during Storage and Biphasic Dissolution
Author: L. Sarode, S. Malekar, C. Cote, and D. R. Worthen
Sponsored By: Nisso America
The purpose to compare HPC-SSL versus PVP-VA as pharmaceutical formulation excipients for the production of hot melt mixed ASDs of FLD. |
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Tableting Performance of Sorbitol Excipient
Author:Marjorie Lejeune
Sponsored By: Tereos Syral
Tereos Syral has conducted a formulation study to assess the tableting performance of sorbitol excipient (spray-dried and crystalline) against lactose when associated with ascorbic acid at 25‰. It shows that sorbitol ensures high quality, while providing competitive advantages in terms of hardness, friability, color stability, dilution potential, and dissolution profile. |
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Melt Extrusion - Shaping Dosage Forms in the 21st Century
Authors: Charlie Martin, Feng Zhang, PhD, and James C. DiNunzio, PhD
Sponsored By: Leistritz
Melt extrusion has been an established industrial manufacturing technology for more than 50 years. It is only in the last decade or so that it has emerged as a viable platform for pharmaceutical development. Today, applications of melt extrusion range from controlled release systems to oral bioavailability enhancement and show potential for small molecules and therapeutic peptides. |
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2014 QMS Health Check
Author: Martin Lush
Sponsored By: NFS International
Time to take a look at your QMS. Time for an overdue Health Check. With increasing numbers of FDA 483 warning letters, consent decrees, and recalls, it,s time to evaluate your QMS. Time to take NSF Health Sciences Pharma Biotech's QMS Health Check to ensure your business is ready for 2014. |
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Leak Rate Testing for Freeze Dryers
Author: Lisa Hardwick
Sponsored By:Baxter BioPharma Solutions
A study was performed to use a more scientific approach to establish leak rate acceptance criteria, by answering the question: What is the maximum volume of air that can leak into the freeze-dryer without violating the Class 100 / Grade A microbial specifications? |
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5 Rules of Sensor Placement in Mapping Studies
Sponsored By: Baxter BioPharma Solutions
This 1-hour webinar will outline 5 rules for good sensor placement in environmental mapping studies, including how many to use in different types of environments. We review mapping guidance from ISPE that covers environments ranging from warehouses to table-top incubators and small refrigerators. |
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How Can Manufacturing Get More Out of Rheology?
Author: Robert G. McGregor
Sponsored By: Brookfield Engineering Laboratories
Rheology is the science that investigates the flow behavior of materials. Whether the product is a liquid, cream, paste, or powder, manufacturing transfers raw ingredients through multiple processing stages to create the finished product. |
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Industry Report on Viral Destruction: Smooth thermal processes consistently and effectively destroy these germs
Author: John Miles
Sponsored By: MicroThermics
This Q&A report includes information on viral inactivation and sterilization; and integration, scale up, and advantages of high temperature short-time (HTST) and ultra-high temperature (UHT) processes. |
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How to Control the Nutraceutical Supply Chain
Author: Jonathan Feinbaum and Anthony Harnack
Sponsored By: Aptean
Myriad regulations pose compliance challenges for drug manufacturers, but if done successfully, business opportunities can arise. |
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Keeping Relative Humidity Calibrated: To find the right vendor you need to ask the right questions
Author: Jonathan Feinbaum and Anthony Harnack
Sponsored By: Rotronic Instrument Corp
Many processes in pharmaceutical science require controlled humidity to produce the desired product and preserve the necessary quality control. To maintain a humidity-controlled environment, manufacturers must keep instruments calibrated. Do you really know your relative humidity calibration vendor? |
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Aqueous Critical Cleaning: A White Paper
Author: David Love
Validation white paper – This comprehensive white paper covers the how to design and execute a cleaning validation in the pharmaceutical industry. It covers the determination of limits and how to perform aspects of cleaning validation such as sample collection. |
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Robotic teamwork - Complex Assembly with Inspection and Laser Welding
Author: Felix Henning
Sponsored By: OPTIMA pharma GmbH
A form of administering drugs that goes beyond anything known to date, is the associated process in which several components are joined into one another and to some extent welded as well. The medication container, which resembles a carpule, only constitutes a product that is ready for use together with numerous other components. |
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