The lubrigone1 has been developed to achieve a lubrication free stopper design for Auto Disabling Prefillable syringes in glass or polymer. The design comprises a symmetric double rib stopper with a soft joint between the sealing elements ensuring sequential movement of the stopper achieving a significant reduction in the break loose force.
The symmetrical design enables a non-oriented mounting sequence, and lubrigone1 ensures full sterility despite potential movement of the stopper which may occur during flights at high flight altitudes and hence low pressure altitudes.
Similar to other lubrigone versions it offers optimum preservation of sensitive liquid injectables by omittance of any lubrication means of both stopper and the container with which it interacts.
It offers excellent performance while eliminating the need for lubrication means including coatings, siliconization and baked-on surface of the container.
Container closure integrity is optimized by the stopper material in combination with the sealing element design carefully balancing friction and closure between stopper and container.
Lubrigone1 combined with 0.5 ml polymer easyject AD-syringe is designed to comply with re-use prevention regulations concerning devices for fixed dose immunizations.
BROCHURES AND DATA SHEET
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Besides our data sheet, we have extensive test reports on extractables, container closure integrity, break loose and gliding forces.
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Existing prefillable syringe systems on the market predominantly use traditional stoppers, which have a strong adhesiveness towards especially glass but also polymer container materials, necessitating the use of lubrication means to ensure satisfactory emptying forces without any potential harm to the patient.
Parts of the drug formulation which are sensitive to silicone oil or coatings may undergo heterogeneous nucleation at silicone droplet surfaces and may cause an irreversible change in conformation and an increased risk of protein aggregation. Ultimately this can cause an adverse effect on the drug, alter the immunogenic response and reduce its efficiency.
lubrigone’s novel combination of the sealing profile design and special material characteristics comprise a solution with low static and dynamic forces without the traditional need for lubrication or coating of the stopper and container, resulting in a clean injection system.
Strandvejen 60, 5.
Phone: +45 2785 1000
CVR/Org. No.: 3580 6555
INJECTO can deliver prefillable syringes and syringe components for ready-to-use liquid injectables
Clean injection systems...
Our components are high-precision injection moulded and can be provided for syringe solutions that are lubrication free, coating free, silicone oil free and baked-on silicone free
Feel free to contact INJECTO for more information