To best accomplish this complex task of high mix and low volume, the process is best reduced to cells (common processing steps performable on a single system). With standardisation of the common steps, individual cells can be sized to complete a suitable fraction of the required output for a facility. In doing so, multiples of these cells can be used when necessary to gain flexibility or throughput depending upon the priority for the given product.

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For far too long, this process has relied heavily upon the human for operation of these processes. Which by definition puts a large mammal, replete with bacterial, viral, and fungal contaminants, in close proximity to these containers and the process. As has been reinforced through history, religion, and common knowledge, humans are far from perfect.

Link to Clean Air and Containment Review…

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With the increasingly serious issues of drug shortages, manufacturers are looking to adopt new strategies that meet global current Good Manufacturing Practices, as well as provide more cost-efficient operations. The adoption of advanced aseptic robotics is increasingly a focus for new operations, and one in which strategies that balance these needs will be presented.

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“We identify companies that have both innovative technology and a fit within the industry value chain. Our analysis of the market and the company progress led to our selection of Vanrx PharmaSystems as a Ready to Rocket Life Sciences company.” said Thealzel Lee, Senior Partner, Rocket Builders.

About Ready to Rocket
Ready to Rocket is a unique business recognition list that profiles technology companies with the greatest potential for growth. Each year, based on analysis of trends, Rocket Builders identifies the top private companies that are best positioned to capitalize on these trends to achieve growth. This selection methodology has been an accurate predictor of investment and business success with past “Ready to Rocket” companies.

Link to Ready to Rocket…

In Search of a Sterile Fill
Technological developments make it easier to manufacture sterile parenterals.

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Procyshyn pointed out that the pick-and-placement and visual analysis functions in fill and finish are ideal for automation. “One thing we’re focusing on is developing tools and techniques for use in areas where isolator technology and peroxide sterilization is possible.”

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Precarn’s T-GAP program will bolster the efforts of 14 growing Canadian technology companies, of which Vanrx Pharmasystems is one.

As a result, Vanrx will collaborate with Saskatchewan Research Council (Saskatoon, SK) to demonstrate the flexibility and reliability of the Vanrx RAPTOR Aseptic Workcell. The SRC facility will play host to a full RAPTOR installation and deployment, where the system’s advanced sterilizeable robotics for aseptic filling will be tested and validated in a real-world environment leveraged by SRC’s experience in vaccine and biological product development.

About Saskatchewan Research Council
The Saskatchewan Research Council is Saskatchewan’s leading provider of applied research and development (R&D), and technology commercialization. With more than 340 employees, $41 million in annual revenue and 62 years of R&D experience, the corporation provides services and products to companies around the world.

Link to Precarn press release…

Speakers from both equipment companies and drug manufacturers presented the latest in isolator technology and the maturing field of isolator integration of new technologies. Thomas Huber of SKAN presented his analysis of isolator technology adoption and its current growth phase state in the industry, as well as SKAN’s latest product innovations and future plans for development. Roche presented its impressive new Kaiseraugst Parenteral Production Facility, which features multiple isolator and RABS lines with a focus on loss prevention and line efficiency.

Phillipe Fontcuberta presented on the application of e-beam technology in isolated filling operations, and the importance of process variables in the implementation of e-beam systems. Rounding out the presentations from industry, Koji Kawasaki presented on the Japanese perspective in isolator and RABS installations with advanced technologies and integration requirements.

Ian Thrussell of the UK Medicines and Healthcare products Regulatory Agency spoke on his personal experiences in isolator technology from both the manufacturing and regulatory perspectives. Stressing the importance of understanding of the manufacturing process in design of isolator systems, Mr. Thrussell provided discussion on the regulatory implications of improper design and operation of isolator systems, as well as the opportunities and superiority of well thought out systems when compared to conventional cleanroom technology.

Chris Procyshyn of Vanrx presented the launch of the Raptor system and discussed the design approach and philosophy for process integration and adaptability. As isolator technology becomes the standard in aseptic operations, robotic technology is a natural and important accelerating technology enabling risk reduction and efficiency in the modern pharmaceutical facility. Vanrx’s vision-guided robotics systems was demonstrated through video and future steps for the Raptor system discussed.

From this conference and others in 2009, a clear picture of isolator technology being the new and current standard for GMP aseptic operations has emerged. Companies across the globe are successfully employing isolator technology and realizing enormous cost and quality benefits as a result.

The focus on removal of human intervention was a highlight of the FDA Q&A session, where representatives from the FDA CBER and CDER groups commented on recent experience and the direction of the agencies priorities going forward with aseptic operations. FDA was clear in stating that isolator technology has emerged as the current standard, with the obsolescence of conventional manned cleanroom technology on the horizon. Both CBER and CDER representatives remarked that neither group has rejected a single application involving isolation technology, highlighting the benefits in operation and product protection for new drug processes.