A 15-Minute Guide To Clinical Trial Document Management And The eTMF
This 15-Minute Guide describes the documentation challenges presented to pharmaceutical companies that outsource clinical trials to CROs. It covers industry adoption of the TMF reference model as the basis for electronic trial master files (eTMFs) — and how eTMFs improve document visibility and provide easy, secure access throughout a trial. Learn more.
By Bernard Fenner, Bosch Packaging Technology
With a third fewer drugs being developed than ten years ago, pharmaceutical companies now have a greater need to differentiate elsewhere. This decrease in new medications, together with the rise in population and changing dynamics in the marketplace, influences how packaging is implemented and integrated into the global development, production, and marketing of pharmaceuticals.
By David A. Loy, Senior Director of Quality and Regulatory Affairs, Aphena Pharma Solutions
With every recurrence of confirmed counterfeit drug product in the pharmaceutical supply chain, the pressure increases to establish a national standard for pharmaceutical track-and-trace solutions. Although a universal standard has yet to emerge, there is one set of requirements that is currently driving action: the California Board of Pharmacy's ePedigree.
By Donald J. Dobert, President, ATL Medical-Pharmaceutical
Follow these ten tips to clearly define your needs and the function of the product. Your vendor may be able to suggest cost-efficient ways to improve product quality and lower unit price.
By Paul Miller, Vice President and General Manager, Nilfisk Industrial Vacuums
An estimated 30,000 U.S. facilities are at risk for a combustible dust fire or explosion, according to the Occupational Safety and Health Administration (OSHA). Many of you are likely thinking, “Well, not my company.”
By Christine Banaszek, Application Engineer, Charles Ross and Son Company
If you haven’t tested a variety of mixers during the past few years, forget all the rules you used to rely on to distinguish one mixer from another. According to the old rulebook, mixers fell into neat categories according to their capabilities and the requirements of your application. Once you identified the viscosity of your materials, for example, the shear required, and the target particle or droplet size, you could quickly narrow your equipment choices to one or two likely candidates. Well, those days are over.
By Dan Catizone, QuickSTAT
Much has been written about cold chain logistics, however, successful and efficient planning still presents many challenges. One of them is choosing an appropriate packaging system. (You can learn more about overcoming cold chain logistics challenges in our white paper "Best Practices in Cold Chain Logistics Planning.")
By Kenneth Maltas, Vice President of Engineering; Auston Matta, Engineering Team Lead R&D; Kevin O'Donnell, Technical Director; D'Arcy Ryan, Director of Marketing, ThermoSafe, Sonoco Protective Solutions
Storing and shipping highly temperature-sensitive drug products requires sophisticated packaging to ensure that the product remains safe and viable — from the manufacturing plant to the end user. Incorporating the appropriate ambient temperature profile into the design of this packaging is critical to maintaining the temperature control that these products require.
By Darrick Niccum, Senior Global Product Manager - Biotechnology, TSI Incorporated
While real-time viable particle counters offer significant potential benefits, they also present some new challenges to industry and regulators. This article will address the unique challenges associated with evaluating, testing, and validating this new family of RMM instruments.
By Randy Klimek, Project Manager, Konica Minolta Sensing Americas, Inc.
Spectrophotometers are a special class of devices that are used to detect and to analyze visible wavelengths of light reflecting off of, or passing through, a sample object. There are many types and styles of spectrophotometers, each with a specialized purpose that can, for instance, analyze the colors of food and other products for health and quality inspections. Recently, however, spectrophotometry, the area of science in which spectrophotometers are used, has been used in the fight against fake and counterfeit drugs.
By Georges Schmidt, Hach Lange Sàrl, Geneva, Switzerland, Hach Company - Particle Counting Division
In the past three decades, ozone has become a very important and efficient tool to achieve high-quality, pharmaceutical-grade water. This paper will address two main topics that are critical for the effective use of ozone within the water processes of the life sciences industry.
By Yvonne Yeo, Bioquell Inc.
RBDS or room biodecontamination service, is not only about the practical side of service delivery. We understand that it is important for our customer to hold detailed records of what actions were performed on their site, ready for regulatory or audit inspections, including batch and serial numbers, equipment locations, biological indicator locations, and results. This, of course, is on top of the risk assessment, method statement, contract briefing note, scope of works, and other cycle optimization documentation.
By Betty Howard, Radiation Tech Team Manager, STERIS Isomedix Services
Many sterilization methods are available for pharmaceuticals, healthcare devices, and lab ware, including steam, sterile-filtration, ethylene oxide, vapor-phase hydrogen peroxide, electron-beam irradiation, and gamma irradiation. Each technique needs to be evaluated before use based on various criteria. Most importantly, one must consider how the technique will affect the final product characteristics and performance.
By Dipl.-Ing. Sebastian Kundel, Product Manager Process and Control Valves, Bürkert Fluid Control Systems
With conventional centralized automation of process valves in production units for food, drinks, and pharmaceutical products, it is often difficult to meet the necessary stringent hygiene and safety standards. Intelligent process valves with integrated automation functions offer an interesting alternative in this field and can help reduce planning, installation, and maintenance costs.