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® 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.
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West recommends Formulation 4432/50
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® 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.