Various experts published and talked about the Closed Vial technology. Here are some of their views, in their own words
European Compliance Academy, Düsseldorf workshop. Personal opinion from Dr. Jean-Denis Mallet (Former Head of the Pharmaceutical, API and Cosmetics Inspection Department at the French Health Products Regulatory Agency (AFSSAPS)) - March 10, 2010.
Can the Closed Vial filling equipment be surrounded by Grade C environment? I would say "yes" because the vials are permanently closed.
FDA, US Food and Drug Administration, Questions and Answers on Current Good Manufacturing Practices, Good Guidance Practices, Level 2 Guidance Production and Process Controls - August 4, 2004, updated November 19, 2009.
What is the acceptable media fill frequency in relation to the number of shifts? Normally, media fills should be repeated twice per shift per line per year. Is the same frequency expected of a process conducted in an isolator?
...Certain modern manufacturing designs (isolators1 and "closed vial" filling) afford isolation of the aseptic process from microbiological contamination risks (e.g., operators and surrounding room environment) throughout processing. For such closed systems, if the design of the processing equipment is robust and the extent of manual manipulation in the manufacturing process is minimized, a firm can consider this information in determining its media fill validation approach...
1This does not apply to RABS (Restricted Access Barrier Systems)
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Pharmaceutical Processing, May 2009
Cover story, 2009 Facility of the Year Award
Elegantly Simple, Aseptic Technologies' CVF System wins Equipment Innovation Category
PDA Annual Meeting, Las Vegas, April 2009
Martin VanTrieste, AMGEN Vice President Quality, Commercial Operations
As a conclusion on his speech, Martin VanTrieste said: "The Future of aseptic filling is already there" showing the videos of the Closed Vial filling lines.
Laureate Pharma, manufacturing matters, March 2009
James P. Agalloco, President of Agalloco & Associates
"These new technologies have enormous potential (...) These new container designs and robotic systems can reduce potential contamination to levels unattainable by other means. It seems apparent to me that these innovations will gradually replace many of our current methods of manufacture.
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Focus, issue 9, Foster Wheeler's Pharmaceutical Business Magazine
The Pharma Division in Milan was invited to give a presentation at Novartis' internal "Quality Master Program on Clean Room Technology: the Next Quality Level".
Germana Molinari, Manager of fill/finish process design, introduced Closed Vials technology.
This new technology addresses two questions essential to the pharmaceutical industry:
1. Is it possible to reduce the critical area to be strictly controlled without an escalation of complexity and rigidity in operations?
2. Is it possible to apply to vials the same concept of ready-to-fill containers currently largely used for syringes?
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