Medinstill - A Dose of Confidence

Medical Instill Technologies (MedInstill) was founded in 1986 by Dr. Daniel Py, MD, ScD in Physics. Since its inception he has served as CEO and Chairman. Prior to the creation of MedInstill, Dr. Py served as a surgeon in France and then as a Director of Research at Merck, responsible for ophthalmic product development.

MedInstill has spent the past 26 years on the development of the safest and simplest Sterile Filling, Sterile Dispensing and Sterile Connecting technologies. Most recently, MedInstill comp leted the whole sterile system from manufacturing to dispensing with in line sterilization of its closed devices.

Throughout its existence MedInstill has thrived to make these technologies cost effective, safe and accessible to everyone. With breakthrough regulatory approvals, MedInstill stays focused on its goal to make all liquid pharmaceuticals and consumer goods preservative free.

By pure mechanical engineering of the delivery devices, the therapeutic index of the product to be administered or consumed is increased, while manufacturing and cost are made safe and most cost efficient while making it more cost effective for both manufacturers and patients/consumers.

With over 50 employees and with approvals/qualifications by the EU, PDA, NSF and LACF, MedInstill has a fully proven system which is now commercialized. While we keep improving existing technologies, members of the team are now fully dedicated to scaling them for specialty uses including Hospital Acquired Infections, Disaster Response, Emergency Manufacturing, and Customizable Filling for pharmaceutical and nutritional purposes.

Intellectual property is a main asset of MedInstill with an extensive patent portfolio covering both its core Intact™ technologies as well as the use of those technologies. The company has over 300 issued patents and over 100 pending applications.

MedInstill has a fully integrated research and development team in New Milford, CT. The organization has been built to transition projects from conception through testing, validation, and filling in an extremely rapid time frame. Process follows three distinct phases: (1) conception phase, (2) development phase, (3) testing, and (4) sterile fill.

Conception Phase

Computer Aided Design. In order to facilitate design conception and iteration, MedInstill has computer design expertise with PRO-E CAD stations and experienced engineers. This allows for rapid, three dimensional solid modeling of parts and assemblies. Typical design and modeling take place in hours, not weeks.

In addition to solid modeling capability, MedInstill has mold design, mold flow analysis, finite element and stress analysis tools to rapidly design parts to meet design and manufacturing specifications. This minimizes the amount of iterations necessary in the development process by performing detailed analysis to ensure the manufacturability of the parts adherence to dimensional and functional requirements.

Rapid Prototyping. Even the most meticulously computer designed parts must be prototyped and tested to ensure proper fit and function. To do this, MedInstill has built state-of-the-art rapid prototyping capabilities, which include:

• A stereo lithography machine (SLA) that takes a computer generated solid model and “print” it into an epoxy-like three dimensional part. This allows for the creation of actual parts of virtually any shape within 24 hours. While the material properties will not be the same as the final parts, this allows MedInstill to make parts quickly for a variety of scenarios and finalize the dimensional design.
• Computer-driven CNC (Computer Numerical Code) four-axis milling machine and lathe, which allow for the rapid machining of metal parts and mold components. As with the SLA, these machines receive information from the computer models and rapidly make actual parts. These parts can be used as components of filling equipment or molds for the manufacturing of test samples and final parts.
• Full mold capability including an electromagnetic discharge machine capable of “burning” highly accurate multiple cavity molds. This capability is used to make molds for prototyping and test samples, as wells as pilot production molds.
• Three thermo plastic injection presses including a double screw machine for the molding of multiple prototype and test samples. This allows for rapid manufacturing of prototypes and test samples using a variety of potential final materials. These machines have been used to mold up to 50,000 containers for the validation testing of the Intact™ sterile filling machine.
• Liquid silicone press for making silicone parts. Unlike most thermoplastic elastomers, liquid silicone remains flexible and elastic at -70°F and retains its properties up to 4050°F. MedInstill is taking advantage of such material in the design of some of its valves and connectors.
• Two injection blow molding units. Blow molding allows the manufacturing of hollow plastic objects, such as bottles, by forcing a parison into a mold cavity and shaping by pressurized air. Different shapes can be made by using interchangeable sets. 
• One X-ray machine which allows to “see” and inspect the parts to quickly validate the various components/functionally of a device. X-ray images allow the inspection of the inner structure of a device, which is typically not detectable with just a visual examination.

Development Phase

Once the design requirements have been finalized and the conception phase is over, MedInstill will typically build a prototype mold, manufacture the required parts, and assemble the unit for testing.

Testing

MedInstill maintains in-house the mechanical and dynamic test labs that allow for full validation of design concepts and approval of devices for production. Micro challenge tests are routinely performed both by liquid immersion and aerosol exposure. These tests also assist in modifying and improving designs in progress. MedInstill also leverages certified external laboratories for chemicals and microbiological testing to ensure 3rd party validation of critical elements.

Sterile Fill

The final step in the development is pilot production and filling of the devices. This involves design and development of associated assembly fixtures, filling machines and materials handling processes.

Once the parts have been molded and assembled together, the devices are X-rayed for quality control.

Finally, MedInstill can sterilize the devices in-line before sterile filling in its Nutrition and Pharma Pilot Plants.

Intact™ Filling Technology

• Vaccines have been manufactured using the closed vial technology since 1998
• In August 2003, the first Intact™ Filling machine was qualified at PDA (Parenteral Drug Association) with a 30,000 media fill
• In 2007, one of our licensees, Aseptic Technologies, has filed two DMFs based on MedInstill closed vial technology in the USA (BB-MF-13382 at CBER AND 20555 at CDER)
• In June 2011, the first vaccine using the closed vial technology for primary packaging was approved by the EU (See EU/1/09/508/011)
• In September 2011, MedInstill submitted to the FDA a 510k for the INTACT™ containers and a new DMF for its INTACT™ Modular Filler

Intact™ Valve

• In 2009, the Intact™ Valve has received two LACF acceptances (for low acid liquid product aseptic processing)
• The first one-way valve using the Intact™ technology was launched in Europe in June 2010
• In January 2011, the second generation Intact™ valve has received a letter of equivalence from LACF
• In September 2011, NSF International established new requirements in NSF 18 for dispensing equipment designed to maintain the safety of liquids highly susceptible to contamination, held under controlled conditions without refrigeration. Intact™ technology is the only dispensing technology which has been able to meet NSF requirement.

New Milford, CT Facility

MedInstill’s facility is registered as:

• Food & Nutrition establishment (CFSAN)
• cosmetic establishment (CFSAN)

John Py Initiative

In the field of sterile dispensing

Nestle SA (www.nestle.com)

Nestle press release

In the field of sterile filling of vaccines and injectable pharmaceuticals

Aseptic Technologies (www.aseptictech.com) and GlaxoSmithKline Biologicals (www.gsk-bio.com)

GSK press release

In the field of sterile filling of cosmetics and cosmeceuticals

Encube Ethicals Pvt. (www.encubeethicals.com)

Encube Ethicals Pvt. Ltd. is a progressive CONTRACT MANUFACTURING company dedicated to the semi-solid preparations of creams, ointments, gels, lotions and solutions.

The state of the art plant of Encube Ethicals, commissioned in Goa in March 1998, is approved by international regulatory health authorities including FDA and EU agencies and accredited with various awards and laurels.

General Purchase Terms and Conditions

View the Terms & Conditions Document