Pharmaceutical Technology Whitepaper Alert:
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Featured Whitepaper
Case Study: Leading Pharma Co. Protects IP and Streamlines "Sign & Witness" Process using Integrated, Trusted Timestamping
Sponsored By: Surety, LLC
For this large pharmaceutical company, the legal protection of their intellectual property research data in their lab management workflows was questionable – they could lose ownership, revenue and potentially their business if they couldn't prove time of creation ("first-to-invent") and authenticity decades into the future. Learn how they integrated a simple, automated control to protect their scientific intellectual property, and streamlined their "signing and witnessing" processes for legal defensibility. Without such a control, the company could expose itself to lost IP claims, rejected patents, and ultimately lost revenue. |
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Nano-Scale Compounding via Hot Melt Extrusion (HME)
Authors: Charlie Martin
Sponsored By: Leistritz
Hot melt extrusion is emerging as a preferred manufacturing methodology for dosage forms. The high cost and limited availability of raw materials during the development phase has resulted in the need to process small amounts of API's/excipients via extrusion to determine process viability. Experimental data is presented on a new twin screw extrusion device that can process as little as 20 to 100 gram micro-batches, as well as a scale-up path. |
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Linking CQAs to CPPs in Life Science Manufacturing
Authors:
Randy Tatlock, Senior Application Specialist, Aegis
John Helfrich, Vice President, GMP Automation Programs, VelQuest Corporation
Sponsored By: Aegis Analytical Corp
You've identified CPPs & CQAs in your process. Link them unequivocally with cause & effect analysis. Watch our webcast and explore best practices for understanding relationships between CPPs & CQAs.
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The New Approach to Track and Trace
Authors: John Lewis
Sponsored By: Cognex Corporation
As pharmaceutical manufacturers confront increased margin pressure, they will look for new ways to lower costs of installing and maintaining production lines. Choosing smart camera vision systems over PC-based vision systems can be an advantage that often results in a solution that's less expensive to install and maintain. |
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Clean-In-Place Automation – Glatt Coating Pan
Authors: Torben Anderson
Sponsored By: MORK Process Inc.
This case study covers the implementation of an automated Clean-In-Place system into a Solid Dosage application of a Glatt Coating Pan. This application resulted in the automation of a manual cleaning process while shortening time to clean and improving the quality and consistency of clean. |
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Benefits Of Steam System Audits
Authors: Dawn Cartwright Dukes
Sponsored By: Spirax Sarco, Inc.
A clean- or pure-steam system provides the correct quality and purity of steam within operating parameters. A steam-system audit is economically sound, improving operation, safety and environmental stewardship. |
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Quantitation Limit of Pharmaceuticals Determined by UV-Vis
Sponsored By: Shimadzu
Illustrating the method of calculating quantitation limits based on measurements conducted using a UV-VIS spectrophotometer. This makes it possible to verify the lower limit of residual substances and residual detergent for cleaning validation. |
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Rapid Analysis of Pharmaceutical Compounds in Dried Blood Spots
Author: Joanne Mather and Paul D. Rainville
Sponsored By: Waters Corporation
The high sensitivity available by combining Waters ACQUITY UPLC with Xevo tandem quadrupole MS makes it an ideal solution for analyzing samples derived from DMPK studies in a dried blood spot format. |
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Addressing the Challenges of Complaint Handling
Sponsored By: Sparta Systems
This white paper outlines the challenges of complaint handling and common obstacles faced by life sciences companies in this area. The paper highlights how quality management solutions can improve compliance, product safety and workflow performance. |
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Moisture Activated Dry Granulation using Starch
Author: Carrie Shipley, Susan Freers
Sponsored By: Grain Processing Corporation
Using pregelatinized starch as the absorbent diluent in the Moisture Activated Dry Granulation (MADG) process, combinations of maltodextrin and povidone were tested to determine optimum binder level. |
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Cleanroom Garment
& Accessories |
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Donning by Design
Author: Damon Larkin
Sponsored By: KIMBERLY-CLARK PROFESSIONAL*, KIMTECH* Brand
This paper addresses the importance of process protection in cleanrooms via the appropriate cleanroom suit. It provides an overview of the sterile cleanroom apparel category and defines key areas for improvement. It introduces a new concept for sterile cleanroom gowning to help minimize the problems associated with current technologies. |
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