Can't Make It To Interphex This March?
Tune in on March 19 and 20 as we stream radio-style interviews LIVE from the show floor! Join radio hosts Todd and Todd for a two-day program featuring attendees, exhibitors, and subject matter experts. Broadcasting Schedule: Get the schedule to all the radio interviews that will take place live at Interphex 2014!
By Trisha Gladd, Editor, Pharmaceutical Online and Bioresearch Online
It's been more than three months since President Obama signed the Drug Quality and Security Act (DQSA) into law, and some of the industry is still unsure how to proceed with preparation for Title II, which outlines the plan for supply chain security. In a recent discussion with Pharmaceutical Online, Ilisa Bernstein, Pharm.D, JD, deputy director of the U.S. FDA Office of Compliance in the Center for Drug Evaluation and Research (CDER), encouraged the industry to familiarize itself with the law and the requirements under it.
By Sergio Mauri, Manager, BU Integrated Projects, Fedegari Group
The blockbuster-model that was driving the pharmaceutical manufacturing industry in the last several decades has almost ended. Massive production, large batches, high-speed lines have been designed to supply the patients with "multipurpose" small molecule drugs to cover the huge worldwide demand of health for the most common diseases. The next generation drugs will focus on the single patient and be designed to cover the individual health demand. For instance, biotech products and large molecules are the most promising therapeutic means for treatment of different kinds of cancer.
By Jeff Montross, Regional Sales Manager, Servolift
With respect to the proper deployment of an intermediate bulk container (IBC) blending and handling system, it is always important to look closely into the handling of the IBCs from a before and after blending perspective. A comprehensive plan for IBC handling can optimize your process and eliminate inefficiencies.
By Michael Boetzkes, Quality Manager, Vaisala Canada Inc. Life Science Division
Any good quality manager knows that assumptions about an instrument can lead to unpleasant surprises during the calibration cycle. Test and measurement equipment play a critical role in most production and development processes. These instruments are used to make decisions regarding the effectiveness of processes and to ensure product quality.
By Joe Gecsey, MET ONE/Hach Company
Dependable, consistent, and repeatable results in monitoring airborne particles in cleanrooms and clean zones depends both on the sampling technique of the analyst and on the performance of the particle counting instrument. The control of the sampling technique often is the subject of a unique SOP (standard operating procedure) while the performance of the instrument is typically reviewed and verified through an annual or semiannual calibration process.
By Adrian Possumato, Vice President, Healthcare Packaging
Maintaining drug stability, quality, shelf life, safety, and efficacy is often achieved by using a sorbent to manage moisture, remove oxygen, or eliminate volatiles in the drug or device packaging headspace. With so much at stake, sorbent insertion is a critical step in the pharmaceutical packaging process. Unfortunately for manufacturers, automated insertion can create challenges on the packaging line when not properly implemented by a reputable supplier that can offer technical expertise and customized solutions.
By Maik Jornitz, COO, G-Con
Reducing the cost of goods sold has become a focus of pharmaceutical facility, cleanroom, and process design, especially as blockbuster patents have begun to expire and generic competition has intensified. The need to minimize manufacturing costs sparked a multitude of creative ideas.