The Food and Drug Administration calls it a “paradigm shift” innovation in sterile filling and packaging. The Closed Intact Transfer technology is a unique and innovative outcome of bridging microbiology and physics by MEDinstill, New Milford, Conn. The premise of the core technologies is to keep all products free from exposure to the environment, thereby preventing product contamination as well as protecting operators and environment from the product.
Based on the principle of closed system transfer, MEDinstill’s filling technology allows for dairy product manufacturers to fill with a much greater sterility assurance level than with existing aseptic technologies, even while operating in a controlled non-classified environment (Class 100,000 or ISO 8). The product is "enclosed" before, during and after the filling step. The filling heads and lines of this machine are disposable. Consequently, CIP & SIP procedures are made obsolete and changeovers are literally reduced to minutes.
Due to this ground-breaking filling solution, initial capital expenditures as well a recurring operational costs are drastically cut while machine uptime is significantly increased, impacting operational bottom lines.
Other critical benefits include:
• The ability to re-pierce the containers’ filling septum, enabling manufacturers to fill bulk product separately from noble/sensitive ingredients which are UHT-sensitive, a feature never before offered by container/filler manufacturers.
• Retrofitting the machine to fill a different device only takes a matter of minutes, drastically reducing downtime for changeovers.
• Ability to scale-up rapidly owing to the patented modular construction of the filling equipment.
MEDinstill also offers a variety of dispensing solutions. All devices are fully closed and sterilized prior to filling and are filled through a septum via a closed system transfer proprietary mechanism. The single dose devices remain sterile until opened, while the multiple dose devices keep the product sterile from first to last dose.
On the dairy front, this facilitates milk and other liquids to be dispensed over the course of time in a shelf-stable manner, making cold chain management or preservatives unnecessary. This sterile, multiple-dose capability has been proven by its application in Nestlé’s Viaggi machine, which was launched in Europe last year and which resulted in a new NSF International standard.
MEDinstill’s technology is easily adaptable to fit a customer’s specific container/pouch needs.
Applications also exist for vaccines, pharmaceuticals and cosmetics. Regulatory authorities have described this patented technology as having “engineered compliance” since it makes redundant buildings, facilities, controls, isolators, gowning and specialized aseptic handling procedures currently necessary for aseptic processing.
MEDInstill's technology is gaining rapid acceptance in the United States, Europe and Emerging economies through its global partner - Ambiance Ventures. For further information, visit MEDInstill.com, or contact BusinessDevelopment@medinstill.com