By Pharmatech Associates, Inc.
Todd and Todd interview Bikash Chatterjee, the president and chief technology officer at Pharmatech Associates. Bikash provides an excellent overview of the global regulatory environment, along with both the opportunities and risks for the pharmaceutical industry. Additionally, he offers expert insights into effective cross-cultural business collaborations and highlights science and technology innovations that will be game changing in the next five to ten years.
By Gary Partington, Walker Barrier Systems
The mobile cleanroom (MCR) is a self-contained manufacturing space fully constructed in our facility. It is shipped to the customer’s facility on a double-drop flatbed trailer in one piece and ready to hook up and use upon moving into place. The MCR has 440 square feet of manufacturing or R&D space, with a main room size of approximately 25'L x 18' W x 9'H. The overall size is 48 ft. long, 18 ft. wide, 12 ft. high, with a weight of approximately 35,000 pounds. The MCR can include ISO 7 or ISO 8 Air Quality in the cGMP clean manufacturing space for aseptic products. It can also be designed for BSL1, BSL2, and BSL2+ clean manufacturing space for biological safety products. BSL 3 and BSL 4 preliminary designs are underway. It can be used inside a legacy facility or in green field construction, and offers a much faster delivery compared to stick-built facilities. Double-wide systems (48 ft. x 36 ft.) are available to provide increased manufacturing space.
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.
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 remote monitoring and measurement instruments.
By Rafik H. Bishara, Steve Jacobs, and Dan Bell, Marken
A decade ago, the way business was conducted between pharmaceutical manufacturing companies and their supply chain providers was typically expressed through verbal expectations at the due diligence meeting, at the audit, or at the first project meeting, and they were pretty much done by written bullet points.
By Andres Lobeiras, Product Manager, Beckman Coulter, Inc.
The percentage of aggregates in bacteria cultures may be determined by employing the Coulter Principle, also known as the electrical sensing zone (ESZ) technique. The ISO International Standard 13319 describes this technique.
Streamlining the regulatory submission process is essential to getting products to market faster today. But you need to create, review, and maintain essential submission-related documentation appropriately, even as regulatory rules and requirements vary and evolve by country and region. And if you've outsourced to contract research organizations (CROs), your submission process must enable reliable, seamless collaboration with these resources.
INTERPHEX is the single source for complete biopharmaceutical and pharmaceutical manufacturing solutions to confidently process all dosage forms of life-enhancing drugs. See, touch, and procure the latest technologies and innovations, March 18 to 20, 2014, at the Javits Center in New York City. For more information visit www.INTERPHEX.com.