Stopper Formulation 4432/50 Gray
Because your drug product has direct contact with the container closure system (vial and stopper), it is critical to consider compatibility factors of the rubber formula when selecting a stopper for your drug package. Formulation 4432/50 Gray, with its superior functional and chemical properties, is West's most highly recommended formula for drug products today.
A formulation designation, such as 4432/50, is associated with a specific recipe. Formulation 4432/50 was custom designed by West to meet the exacting needs of today’s most sophisticated biotech and chemical pharmaceutical drug products. The formulation is part of a Drug Master File (DMF) with the Food and Drug Administration (FDA).
The base material is a chlorobutyl rubber compound that contains no dry natural rubber. Although very specific recipe information is confidential, technical information in report form is readily available from West by contacting your West Representative. Click here to contact a West Representative by phone or email.
West’s 4432/50 Gray is widely accepted because of its versatility in meeting the needs of a broad spectrum of pharmaceutical drug formulations, including various pH ranges, solvents and preservatives.
Selecting a stopper with a barrier film such as West’s FluroTec® barrier film can help further reduce drug/closure interaction. This reduction has been shown by leading pharmaceutical manufacturers who monitor extractable/leachable profiles in their finished drug products.
The formulation is clean, as it complies with all major compendia including current USP, Ph.Eur., and JP. 4432/50 Gray also meets requirements of the Coalition of North Eastern Governors (CONEG) Toxic Packaging legislation.
Formulation 4432/50 Gray is suitable for steam sterilization at levels that are most commonly used in the pharmaceutical industry.
Stopper configurations for serum, dry powder or lyophilized applications, and plungers for pre-fill presentations, are all available using Formulation 4432/50. All configurations are available with the West FluroTec barrier film, which helps protect your drug from potential interaction with the selected packaging system. Your West Representative can guide you through the packaging selection process and provide you with a formal component recommendation.
Stopper Formulation 4023/50 Gray
Because your drug product has direct contact with the container closure system (vial/syringe and stopper/plunger), it is critical to consider compatibility factors of the elastomer when selecting a stopper for your drug package or a plunger for your prefilled syringe. Formulation 4023/50 Gray, with its superior functional and chemical properties, is West Europe's most highly recommended formula for unstable and sensitive biotech drug products.
A formulation designation, such as 4023/50, is associated with a specific elastomer. West designed formulation 4023/50 to meet the exacting needs of today’s most sophisticated biotech and chemical pharmaceutical drug products. The formulation is part of a Type lll Drug Master File (DMF) with the Food and Drug Administration (FDA).
The base material is a bromobutyl rubber compound that contains no dry natural rubber.
Click here to contact West for more detailed technical information on this formulation.
West’s 4023/50 Gray is widely accepted because of its versatility in meeting the needs of a broad spectrum of pharmaceutical drug formulations, including various pH ranges, solvents and preservatives. In addition to having a low extractable profile, this formula is characterised by low water vapour and oxygen permeability. Both parameters are important for lyophilization applications.
Selecting a stopper or plunger with a barrier film such as West’s FluroTec can help further reduce drug/closure interaction. This reduction has been shown by leading biotech pharmaceutical manufacturers who monitor
extractable/leachable profiles in their finished drug products.
The formulation is clean and it complies with all major compendia, including current
USP, Ph.Eur., and JP in traditional sizes. Formulation 4023/50 Gray is suitable for steam sterilization at levels that are most commonly used in the pharmaceutical industry.
Stopper configurations for injectable, dry powder or lyophilized applications, and plungers for pre-fill presentations, are available using Formulation 4023/50. All configurations are available with
West FluroTec barrier film, which helps protect your drug from potential interaction with the selected packaging system.
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West recommends Formulations 4432/50 and 4023/50
for lyophilization and serum stoppers. |
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Stopper Formulation D 21-7S
All aspects of the drug product requirements must be considered when selecting an appropriate rubber closure for your parenteral packaging needs.
D 21-7S is a butyl material formulated specifically for providing excellent oxygen and moisture barrier properties and low water absorption. This formulation complies with all major compendia
including current USP, Ph.Eur. and JP.
Selecting a stopper with a barrier film such as Flurotec components can further reduce drug/closure interaction. This reduction has been shown by leading pharmaceutical manufacturers who monitor extractable/leachable profiles in their finished drug products.
Because of both its functional properties and chemical composition, D 21-7S with Flurotec barrier film is often recommended for innovative drugs. Your West Representative can guide you through the packaging selection process and provide you with a formal component recommendation.
D 21-7S is property of Daikyo Seiko, Ltd., West’s Japanese affiliate for 30 years. West markets Daikyo packaging components in the U.S. and Europe.