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WORKING WITH A CDMO TO IDENTIFY OPTIMAL PACKAGING OPTIONS
Sponsored By: 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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Extractables and Leachables for Pharmaceuticals and Medical Devices
Author: Allen Kesselring, Ph.D.
Sponsored By: EAG Life Sciences
Extractables and Leachable (E&L) studies challenge our industry due to their late stage occurrence and investigational nature. This white paper defines Extractables and Leachables and outlines an E&L study plan that is both scientifically relevant and compliant within GXP regulatory systems. |
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An Introduction to Pharmaceutical Forensics
Author: David Exline
Sponsored By: Gateway Analytical
Pharmaceutical forensics applies forensic expertise, analysis and problem solving principles, and addresses quality issues such nonconformance and deviation investigations, contaminant identification and source determination. This whitepaper provides an introduction to this approach and a case study example of particulate examination. |
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Using Photostability Chambers to meet ICH Q1B Requirements
Author: Katherine Robertson
Sponsored By: Impact Analytical
Stability testing is an essential component during the multi-phase drug development process for small and large molecule API's and small and large molecule drug products. This whitepaper discusses the critical aspects to consider when selecting a stability testing laboratory provider. |
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Analysis of aggregates in nasal spray suspensions.
Author: Dr. Oksana Olkhovyk
Sponsored By: Gateway Analytical
This white paper reviews the importance of measuring particle size distribution and degree of aggregates in nasal spray formulations. Raman chemical imaging is presented as a greatly improved method of analyzing aggregates and agglomerates in nasal spray suspension formulations. Reviews the time and cost savings compared to current practice. |
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Secure Pharmaceutical Shipments
Author: Ryan Henary
Sponsored By: FedEx
When choosing a shipping provider for pharmaceuticals, security should be at the forefront of any decision. The integrity of the supply chain is critical. This white paper details five core questions every pharmaceutical shipper should ask to ensure the utmost attention to detail during critical pharmaceutical shipments. |
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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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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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Implementing Disposable Cleanroom Apparel into the Manufacturing Process
Author: KIMBERLY-CLARK PROFESSIONAL* – (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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Automated Audit Management
Author: KR Karu
Sponsored By: Sparta Systems, Inc.
Learn how audit management solutions enable life science companies to reduce audit time and cost, mitigate risk and ultimately help improve product quality and safety. It also suggests elements to consider when choosing an audit management solution. |
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The Power of Virtual Quality: Optimizing quality in a regulated environment
Author: Troy Fugate
Sponsored By: Compliance Insight Inc.
Sponsor or innovator companies must maintain full responsibility over their processes and products, even when outsourcing or working with third parties. Some of these companies find it increasingly difficult to manage the number of audits or investigations that may be required at the global level on their own. Pharmaceutical Technology spoke with Troy Fugate, Vice President of Compliance Insight to gain some insight into how virtual quality resources can help companies in the current regulatory environment. |
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Using Photostability Chambers to meet ICH Q1B Requirements
Author: Bob Dotterer
Sponsored By: Caron Products
For companies performing photostability testing in accordance with ICH guideline Q1B, Caron’s 6540 series chambers overcome the challenges of lamp selection, light control and other chamber design issues. |
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Pharmaceutical Compliance that Spans the Supply Chain: Considerations for Extending the Quality System Beyond Your Enterprise
Author: Brenda Percy
Sponsored By: EtQ, Inc.
Learn why global harmonization is important in the Pharmaceutical industry, best practices of extending the quality system to the supplier, and how suppliers will benefit from being included in harmonization initiatives. |
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Drastically reduced isolator decontamination cycles
Authors: Felix Henning
Sponsored By: Optima Packaging Group GmbH
With the use of catalytic aeration, M + P is able to reduce the duration of the aeration phase in isolators by about 50%. Those reduced and shortened isolator decontamination cycles have multiple advantages for the pharmaceutical industry. |
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Choosing the Proper Equipment for Pharmaceutical Stability Room Humidity and Temperature Mapping
Author: Clay Hile; Greg Gowaski
Sponsored By: ROTRONIC Instrument Corp
Pharmaceutical and Biotechnology companies are under a great deal of pressure to comply with regulatory requirements from the inception of a product to its final destination. One such aspect of the regulatory process is stability testing. Stability testing allows drug manufactures to expose the product to conditions that might occur in the supply chain, as well as provide for stress testing for determination of shelf life. |
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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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