By Richard Lucas, Ph.D., Bioquell UK Ltd.
The increase in size and scale of bioprocessing is presenting a new challenge. Traditional methods of sterilization, to maintain clean facilities, are becoming difficult to deploy in a controlled and regulatory compliant way.
By Haibo Wang, Ph.D., Edgar Jaynes, Ph.D., Ram Kasina, Ph.D., Anthony Qu, Ph.D., Patheon Inc. To evaluate the HPMC banding process and morphology using different banding agents, and compare HPMC banding and regular gelatin banding processes. To look for a possible new water based HPMC banding process and banding agent to replace the current alcohol/water based HPMC banding.
By Walter Berghahn, President, SmartRMeds For Life Industry and regulatory organizations have been considering a serialization and traceability system for years. Most proposals involve serializing drug products at the smallest saleable unit. Among these, there are two opposing approaches regarding how drugs should be tracked.
By Georges Schmidt, Hach Lange Sàrl, Hach Company 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 Leslie Mather, SP Scientific On occasion, we are challenged with regard to equipment being able to properly seal a customer's selection of container closure system which is typically a glass vial and rubber stopper that is pressed down into the vial during a stoppering step at the end of freeze drying. This became a more frequent problem as dosages and containers decreased in size because this configuration typically requires more force per square inch to create proper stopper seating in the vial.
INTERPHEX is the leading annual pharmaceutical and biopharmaceutical trade show, taking place in New York on April 23 to 25, 2013. Key decision makers will find the networking opportunities, products, services, and information they need to ensure quality and to maximize the efficiency, agility, and flexibility that solve manufacturing and supply chain problems. INTERPHEX is where intelligence and passion intersect with the full spectrum of industry products and services to create new insights and innovation. Learn more.
By Ellen Leinfuss, SVP, Life Sciences, at UL The FDA's "Case for Quality" initiative calls for companies to recognize the interrelationship between of product quality and business decisions and taking the steps to address potential risks.
By Ken Maltas and Iftekar Ahmed, ThermoSafe, Sonoco Protective Solutions There has been significant discussion over the past few years around TAP (temperature-assured packaging) for CRT (controlled-room temperature). Manufacturers and regulators have not yet decided how they want to handle this type of product, although some countries, such as Saudi Arabia, have already mandated that CRT products be shipped in proper TAP. As with refrigerated products, the regulations vary from strict label claim to acceptance of excursions with stability data. A couple of major questions have to be asked before the individual manufacturer or the industry can decide how to design the TAP.
By Kevin Zarnick, Pharmaceutical Sales Manager, Thermo Fisher Scientific The U.S. Food and Drug Administration (FDA) issued the Prescription Drug Marketing Act of 1987 (PDMA) which was then modified by the Prescription Drug Amendments of 1992. Included was Section 503(e)(1)(A) which establishes the pedigree requirement for prescription drugs.