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Featured Whitepaper: Vaisala
5 Frequently Asked Questions about Temperature and Humidity Validation/Mapping
Sponsored By: Vaisala
The FDA mandates validation of incubators, refrigerators, freezers, stability chambers, warehouses, and other controlled environments. Download this NEW application note, which covers five key questions you need to have answered in planning a compliant temperature and humidity mapping study.
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Implementing Disposable Cleanroom Apparel into the Manufacturing Process
Author: Damon Larkin
Sponsored By: KIMBERLY-CLARK PROFESSIONAL*
This paper addresses the benefits of disposable cleanroom apparel versus reusable apparel. It explains how disposable cleanroom apparel can help play a role in helping pharmaceutical manufacturers reduce their waste stream while reducing the risk of contamination. |
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Process Analytical Technology as Key Enabler of QbD
Author: David W. Humphrey / Dr. Brandye Smith-Goettler
Sponsored By: Siemens AG
The Food and Drug Administration (FDA) has championed one initiative, known as Quality by Design (QbD), with the goal of improving productivity and reducing manufacturing costs. Process analytical technology (PAT) is an enabling technology for QbD. Siemens offers a comprehensive, well-integrated solution for process analytical technology (PAT) called SIPAT. |
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How in-line sensors are affecting the pharmaceutical process and validation
Author: Dr. Jorg Pochert
Sponsored By: Hamilton Company
Pharmaceutical Technology conducted an interview with Dr. Jorg Pochert, on a discussion about intelligent vs. in-line sensors. In pharmaceutical processes, in-line sensors generally offer a real-time view of the relevant parameters. In-line sensors make sure processing is done under validated conditions at all times, to obtain the expected product. |
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Blisterpack Integrity Testing Using Sepha VisionScan
Author: Dr. Dorian Dixon, University of Ulster
Sponsored By: Sepha Ltd.
An overview of Sepha's VisionScan technology in detecting integrity breaches in a range of pharmaceutical blister package types using non-destructive methods compared to traditional blue-dye testing. |
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WORKING WITH A CDMO TO IDENTIFY OPTIMAL PACKAGING OPTIONS
Author: DPT Laboratories
There are many factors to take into consideration when selecting or designing a packaging component. Working with a contract development and manufacturing organization early in the process helps eliminate packaging problems that may arise after the development stage. |
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Using Raman Chemical Imaging to Analyze Inhaled Combination Therapies
Authors: Dr. Oksana Olkhovyk
Sponsored By: Gateway Analytical
This white paper discusses using Raman Chemical Imaging as method to analyze dry powder formulations containing multiple active ingredients in order to obtain important data about the aerosolization behavior that was previously unavailable. This analysis offers developers new opportunities to optimize the formulations and the delivery devices for combination therapies. |
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Topical Product Development for Dermatology Products
Author: Barry Calvarese
Sponsored By: Dow Pharmaceutical Sciences
Dermatology drug development presents distinctive and sometimes peculiar challenges that demand creative solutions. What differentiates dermatological drug development from oral or parenteral drug development? |
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Automated Audit Management Best Practices
Author: KR Karu
Sponsored By: Sparta Systems, Inc.
Whitepaper abstract: In response to recent high-profile product safety issues, the quantity and breadth of internal audits and external audits of suppliers and outsourcing partners have increased significantly. With stepped up audits, inefficient, manual, siloed processes are now causing significant problems, including: poor communications and scheduling; inefficient use of auditor and auditee resources; inconsistent audit output; lack of visibility and oversight into trends; and difficulty in ensuring appropriate follow-up on corrective and preventive actions (CAPAs). All these issues can have an adverse impact on operational effectiveness and product quality. |
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Melt Extrusion – Shaping Dosage Forms in the 21st Century
Authors: Charlie Martin; Feng Zhang, Ph.D.; James C. DiNunzio, Ph.D.
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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Q&A Dissolution Enhancement and Controlled Release
Authors: Ashish Sarode, Catherine Cote, Peng Wang, David Worthen.
Sponsored By: Nisso America
Processing techniques for low viscosity hydroxypropylcellulose polymers. Low viscosity HPC-SL and SSL can be employed to produce chemically stable SDs of poorly- as well as highly water-soluble drugs using various pharmaceutical processes in order to control API dissolution. |
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