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Featured Whitepaper: Vaisala
Humidity Measurement in Cleanrooms: The Devil is in the Details!
Sponsored By: Vaisala
Vaisala makes the world's finest humidity sensors and in this article, we describe several observations on humidity measurement in controlled environments. We hope this information will help you clarify your approach to controlling and monitoring this hard-to-measure parameter.
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Three Steps to USP H2O Success
Author: Geoff Sheffrin.
Sponsored By: OBK Technology Ltd.
USP water systems are highly specific in their requirements. To get there successfully is relatively easy BUT you are dealing with a large number of detailed requirements that MUST work in harmony to produce reliable Purified Water or Water for Injection - cost effectively and with minimum maintenance. Here's how. |
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Process Analytical Technology as Key Enabler of QbD
Authors: 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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Implementing Disposable Cleanroom Apparel into the Manufacturing Process
Author: Damon Larking
Sponsored By: KIMBERLY-CLARK Corp
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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Impact of a Customized MALDI-TOF Library for Microbial Identifications
Author: Anne Russell, PhD
Sponsored By: Charles River
This study assesses the suitability of the Biotyper platform for identifying environmental isolates, demonstrates our systematic approach to broaden the reference library and shows the impact of adding new library entries on reportability for this industrial sector. |
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Ensuring Quality & Regulatory Compliance when Collaborating with a Service Provider
Author: DPT Laboratories
In recent years, the pharmaceutical industry has given greater priority and attention to quality assurance and regulatory compliance than ever before. With the FDA’s heightened focus on safety, regulatory agencies are increasing their presence in the manufacturing arena to ensure Current Good Manufacturing Practices (cGMP) are top of mind, and sponsors are placing greater responsibility for meeting cGMP requirements onto their outsourcing partners. While both sponsor companies and service providers must adhere to robust quality standards and undergo regular regulatory inspections, manufacturers are ultimately held responsible by regulatory agencies when it comes to adhering to cGMPs. |
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4 Reasons to Consider Blister Packaging
Author: Paul Dupont
Sponsored By: Ropack Inc.
Blister, an increasingly dominant force in pharmaceutical packaging, is earning notable interest from pharmas and consumer healthcare companies looking to expand market share. Four reasons for the interest in blister are described. |
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Life Sciences Guidebook on Best Practice Compliance Solutions
Author: Tim Lozier
Sponsored By: EtQ, Inc.
This paper provides you with a basic overview for selecting, implementing and using FDA Compliance and Quality Management solutions. Learn the importance of QMS, best practices for FDA Compliance and Quality systems, and tips and tricks for finding the solution best suited for your company. |
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Establishing a Culture of Quality
Authors: Ron Johnson, President, Becker & Associates Consulting
Sponsored By: NSF Becker
For companies seeking to prevent or remediate regulatory compliance violations, establishing a culture of quality is of the essence. In industries strongly affected by regulatory compliance, product quality is inextricably linked to a company’s well-being. Learn more about cultivating and nourishing a culture of quality in your firm. |
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How to Select an Environmentally Preferable Chamber
Authors: Bob Dotterer and Leah Harris
Sponsored By: CARON
There are currently no programs specifically targeted to assist scientists with the assessment of "green" laboratory equipment. We developed this guide to assist with your future chamber and incubator purchases. |
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Is My Method (Still) Valid?
Author: Gerald De Fontenay
Sponsored By: SGS Life Science Services
This paper outlines the importance of method validation including the official requirements, characteristics to be validated and minimum requirements, helping to ensure that the data generated are reliable. |
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Melt Extrusion – Shaping Dosage Forms in the 21st Century
Authors: Charlie Martin; Feng Zhang, PhD; 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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Using Quality By Design To Improve Strength, Friability
Authors: Joe Cobb, R. Justin Brett, Michael D. Ruff, Anthony Berry, Robert Epps
Sponsored By: Metrics, Inc.
Using Quality By Design principles, Metrics Inc. scientists improved the friability and increased the strength of a core tablet destined for modified release dosage form. |
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