Tompkins provides pharmaceutical and medical device customers with DMF formulations specific to their product requirements.
Click here for the DMF Letter of Access Request Form.
Tompkins has a single type-V DMF registered with the FDA, for the following types of stoppers and materials:
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Standard drug delivery components
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Lyophilization Stoppers
- Standard sizes - 13mm and 20mm
- Optimal compatibility, with lyophilazation process
- Excellent seal integrity
- Low gas and water vapor permeability
- Low moisture
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Serum (Standard) Stoppers
- Standard sizes - 13mm and 20mm
- Various top plate piercing thickness available
- Different flange markings available
- High compatibility compounds
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Coated Stoppers
- Flexible total coating with seal integrity
- Bio-compatibly inert
- Silicone Free
- Optimized coring and reseal ability compounds
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Syringe Plungers
- Latex free synthetic polyisoprene rubber
- High elasticity, low deformation
- DI washed and ready for use
- Sterilizable
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Materials
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Polyisoprenes
PolyIsoprene, available in various durometers, compounds and colors is a clean, re-enterable material that has fair oil resistance, excellent physical properties and good resistance degradation by sterilization methods, e.g. GAMMA, EtO and steam. It has the ability to be molded into various shapes such as septa, stoppers, injection sites and various medical device configurations. It is the ‘Synthetic Natural Rubber’ with no latex difficulties. TOMPKINS has a variety of DMF listed compounds to fill your needs. Please contact us for more information on your specific need(s).
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Butlys
Butyl and the halo-Butyl (Chloro-Butyl and Bromo-Butyl) compounds are heat resistant, exhibit very low gas transmission properties and posses moderate resistance to various oils and solvents. Within the family, blends may be made to enhance both processabilty and subsequent end-use properties. As an example, a halo- Butyl polymer may be blended with standard Butyl to yield greater resistance to a specific fluid while maintaining the high temperature resistance. TOMPKINS has a large number of DMF listed single and blend material formulations available to satisfy the specific end-use need. Please contact us for more information to better solve your problem.
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Silicones
EPDM (Ethylene-propylene diene monomer) is a polymer that is heat resistant, has low gas transmission and has excellent resistance to water extraction. It may be blended with Isoprene, the Butyl family and with other polymers to improve both materials properties.
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