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.
To contact West click here; we will guide you through the packaging selection process and provide you with a component recommendation.
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West recommends Formulation 4023/50
for lyophilization and serum stoppers. |
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Elastomeric Formulation D21-7S
All aspects of the drug product requirements must be considered when selecting an appropriate rubber closure for your parenteral packaging needs.
If your drug product is lyophilized (freeze-dried or dry powder) and is extremely sensitive to hydrolysis, D21-7S may be the most suitable formulation.
D21-7S is a chlorobutyl formulation that provides excellent oxygen and moisture barrier properties, has a low extractables profile and has excellent resealing properties. This formulation complies with all major compendia including current USP, Ph.Eur. and JP.
Selecting a stopper or plunger with a barrier film such as Daikyo Flurotec® can 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.
Because of their functional properties and chemical composition, lyophilization stoppers in D21-7S with Daikyo Flurotec® barrier film are often recommended for lyophilized biotech drugs. D21-7S was developed by of Daikyo Seiko, Ltd., West’s Japanese affiliate for 30 years. West markets Daikyo packaging components in the U.S. and Europe.
To contact West click here; we will guide you through the packaging selection process and provide you with a component recommendation.
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Daikyo Formulation D21-7S provides excellent
oxygen and moisture barrier properties. |
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