Featured Whitepaper: Vaisala
10 Articles on Improving Quality, Metrology, and Compliance with cGMP & FDA Regulations
Sponsored By: Vaisala
In this collection four experts discuss several ways to reduce the risks of failed inspections, bad measurement practices, and poor product quality in controlled environments. Topics span from measurement accuracy, uncertainty, stability, and traceability, to a discussion of wired v. wireless connectivity for sensing instruments, to FDA inspection preparation and 483 responses. These articles offer a surfeit of tweaks, tips, and tricks for developing better quality management systems for GxP-compliant environmental monitoring applications.
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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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Finding the right contract manufacturer
Sponsored By: Vetter Pharma International GmbH
Contract manufacturing became popular in many industries during the 1990s as a way to counter rising costs and to reinvestment. The pharmaceutical industry has been slow to adopt this practice because of its absolute need for secrecy.
However, with fewer blockbuster drugs in the pipeline, companies are on the lookout for an enduring solution to meet market challenges. These include rising process costs resulting from stricter quality control criteria, evolving technologies, which are becoming more complex and costly, and the increasing stringency of regulatory standards. To maintain or expand market shares, pharmaceutical companies must devise new strategies to remain competitive. |
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The Case for Upgrading Existing HPLC Assays to UPLC
Author: Eric Hill
Sponsored By: Impact Analytical
UPLC, ultra pressure liquid chromatography, is the successor technology to HPLC techniques and assays that have been widely used since the 1970s. UPLC has emerged from the laboratory over the past few years and moved to the bench top. It offers similar analytic capabilities as the more familiar HPLC, but operates at much higher pressures. This increased, or ultra, pressure provides the advantages of improved resolution, shorter run times, fewer consumables, and similar advances to separation science and those who depend on it to analyze and characterize vital compounds. |
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Robust Analytical Methods for Genotoxic Impurities
Author: Lloyd Currin and Eden Tesfu, Ph.D.
Sponsored By: EAG Life Sciences.
The reactive nature of genotoxic impurities and potential genotoxic impurities poses unique analytical method development and validation challenges. This case study illustrates a difficult development and validation for quantitative analysis of genotoxic impurities and potential genotoxic impurities for methyl, ethyl and isopropyl camphor sulfonate esters in a drug substance. |
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CRITICAL CLEANING APPLICATIONS IN PHARMACEUTICAL MANUFACTURING
Author: Jeff Phillips, Sr. Manager, Science and Marketing
Sponsored By: ALCONOX
Discussion on the benefits of employing aqueous cleaning in pharmaceutical manufacturing. The proper use of aqueous cleaning helps manufacturers minimize surface residue and makes cleaning validation easier. |
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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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Interest Grows in Single-Use Pumps
Author: Wallace Wittkoff
Sponsored By: Pump Solutions Group (PSG®)
One of the key differences between the pharmaceutical and biopharmaceutical industries: the pharmaceutical industry relies largely on synthetic chemical processes while biopharma relies largely on cellular processes. That difference has led to the development of new lines of processing equipment optimized for biologic processes. The latest development is single-use pumps. Wallace Wittkoff, Hygienic Market Director for Pump Solutions Group (PSG®), discusses the need for single-use technology. |
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Asset Accuracy: A professional appraisal is essential to know what you have and what it's worth
Author: Pharmaceutical Technology and Christopher Kinzie
Sponsored By: EquipNet
Pharmaceutical Technology interviews EquipNet’s Director of Appraisals and Valuations, Christopher Kinzie, about how companies can benefit from professional equipment and business appraisal and valuation services. When you know what you have and what it’s worth, you limit risk of liability and maximize the value of your assets. |
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Melt Extrusion – Shaping Dosage Forms in the 21st Century
Author: 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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"Countering Drug Counterfeiting"
Author: Aqeel Fatmi, Ph.D., Global Vice President of Research and Development and Operations, Banner Pharmacaps Inc.
Sponsored By: Banner Pharmacaps Inc.
In addition to regulatory and legal efforts to stem the threat of the growing and serious problem of drug counterfeiting, U.S. drug sponsors are playing an increasing role by incorporating advanced counterfeit-resistant technologies on the dosage form itself, as well as on the packaging. While no single approach is sufficient to solve the daunting problem of counterfeiting across the globe, certain oral-solid-dosage coating technologies that are extremely difficult to duplicate are playing an important role in the ongoing struggle to protect prescription and over-the-counter drug products from counterfeiting and adulteration. Banner Pharmacaps Soflet® Gelcaps, one of the leading technologies to identify counterfeiting, enrobes the tablet core using customized, proprietary equipment, with a tightly adhering gelatin, protecting active ingredients and providing a strong tamper-evident and tamper-resistant barrier. |
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An Introduction to Waters T-Wave Devices
Author: Gordon Kearney
Waters (Div: Mass Spec)
The travelling wave (T-Wave) ion guide enables the precise manipulation of ions in a mass spectrometer in order to enhance sensitivity, selectivity and analytical speed. T-Wave devices enable ions to be contained, moved forwards or backwards at predefined speeds, focused, trapped, sequentially released according to m/z, and separated based on their mobility. |
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Quality Management Systems Demystified
Author: KR Karu
Sponsored By: Sparta Systems, Inc.
Learn how companies are utilizing best-of-breed ERP, EQMS, and PLM systems to save organizations money while increasing compliance at the same time. |
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Improving Product Quality with Risk Assessment Tools
Author: Brenda Percy
Sponsored By: EtQ, Inc.
With the product lifecycle moving so fast, many organizations may ask the question, "how can we effectively measure quality?" The answer is Risk Management. Learn the elements of Risk Management and how they help to identify, prevent, and mitigate risk throughout an organization. |
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New HPC grade for DC
Author: Shinichiro Tsue
Sponsored By: Nisso America
We prepared new Super Fine Powder, Special Low Viscosity grade Hydroxypropyl Cellulose with the purpose of developing a high performance dry binder with high compression formability at low use levels. |
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