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.

 

Official Precarn Release…

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.

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.

Of particular significance to attendees this year was the topic of patient safety and revisiting of industry standards and their effects on infection rates. This topic of patient risk has been addressed with more priority and emphasis in the last two conferences this year, highlighting the trend toward overall risk reduction. The regulators globally are pushing for increased levels of patient protection, and increasingly new technologies are being pushed as the answer in lowering infection rates, and providing this quality without substantial increases in healthcare spending.

Highlights from the Symposium included:

FDA data on intravenous infection deaths stating over 32,000 per year in the United States, greater than the number of motorcycle injury deaths

Cost of Quality for aseptic manufacturers averaging 8-12% currently, with that of solid-dosage manufacturers at 1-3%

Isolator system market growth now accelerating year over year

Containment of dosage manufacturing clearly the future, with increased potency of new drugs

Data to be released this summer at ISPE Arlington conference detailing the substantial operating and overall cost benefits of isolator technology

Vanrx CEO, Chris Procyshyn, presented a session on industrial design of aseptic robotic systems which featured the latest technology from VanRx, the RAPTOR Aseptic Workcell. Delegates were shown a novel approach to isolator system design, employing the latest in manufacturing technology from across industries. Generating a great deal of interest and support among attendees, experts spoke out in support of Vanrx concepts, both from a quality and microbiological perspective. Participating on an expert panel during the symposium, Vanrx shared in the discussion of key decision points for manufacturers and need for continued data-driven decision making in overall process and facility design.

Vanrx highlighted it current plans for development and product introduction for 2009, and will be seen next at the Parenteral Drug Association Annual General Meeting in Las Vegas, NV, April 20-24.