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201 Housatonic Avenue
New Milford, CT USA
+1 (860) 350-1900 / Fax +1 (860) 350-9640
www.medinstill.com
[email protected]
Intact™ Sterile Filling System
Medical Instill Technologies (MedInstill) has developed the Intact™ Sterile Filling System, a novel, patented technology for
aseptic filling of liquids and semi-solids into containers and devices. Intact eliminates the costly investment and
cumbersome steps of traditional aseptic filling, increasing efficiency, reducing costs, and drastically improving quality control
and assurance.
How does it work?: The sterile formulation is moved into the device by sterile fluid path within the system. Filling occurs in
three steps: (a) a non-coring needle enters the device or container through a port composed of a proprietary elastomeric resealable stopper (RSS); (b) the formulation is pumped into the device; and (c) the needle is withdrawn and the port is
immediately resealed using a laser. The entire process is performed in a laminar flow hood without need for isolators.
The key to the success of the Intact Filling System is the fact that the device or container that is filled in the system is already
molded and assembled. The closed device is irradiated for sterility and then becomes an isolator in itself. At no time is the
interior of the device exposed to external environment, completely preventing contamination of the formulation.
The Intact Filling and Sealing Process
Non-Coring Needles Fill Through RSS Port
Laser Reseal After Filling Prevents Contamination
Validation: The Intact Filling System was validated at the Parenteral Drug Association using injectable drug vials developed
with an RSS port. Representatives of the FDA have described the Intact Filling System as “the paradigm shift in aseptic
filling technologies”.
Key Advantages of the Intact Filling System:
•
Cost: The Intact system requires far less capital investment and significantly reduces the number of operator steps and
interference points. Intact Filling System operating costs are considerably lower than traditional aseptic filling systems.
•
Sterility Assurance: Containers and devices are closed, eliminating potential for contamination. Quality Assurance is
monitored using an infra-red sensor to detect the complete reseal of the RSS filling port.
•
Regulatory Compliance: With Quality Control steps minimized and a process that is easier and faster to implement,
regulatory compliance is ‘engineered’ into the system.
•
Wide Product Range: The Intact Filling System can be used for most liquid or semi-solid pharmaceutical formulations.
This includes ophthalmic solutions, dermatologic preparations, and topical medications and will work for gels and
suspensions. The Intact system provides the opportunity to remove preservatives from sterile formulations.
Working with MedInstill – Contract Sterile Filling and Device Development
MedInstill has recently moved into a manufacturing facility and is currently developing contract filling lines to provide
pharmaceutical formulators access to the Intact Sterile Filling technology. MedInstill is seeking to provide contract filling and
development services and to work with customers who have sterile formulations either on the market or in development.
MedInstill technologies offer its pharmaceutical partners with several significant competitive advantages. Please contact us
for more information and a consultation on how MedInstill can make your products Intact.
CONFIDENTIAL AND PROPRIETARY INFORMATION OF MEDICAL INSTILL TECHNOLOGIES © 2005
MEDICAL INSTILL TECHNOLOGIES ALL RIGHTS RESERVED