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Packaging Selection
​GIVE YOUR VIAL
SOME STYLE
The Flip-Off® Seal Color Configurator gives you the flexibility to try a different configuration.

Give your vial a splash of color by selecting a color combination that fits your needs.

Click here to give it a try.
Flip-Off® Seals

Flip-Off® Seals

A Flip-Off seal is your drug product’s first line of protection; it helps keep contamination from getting into the vial and seals the parenteral package. Further, the seal helps to protect the injection site on the vial stopper. Recommended seals consist of an aluminum shell and a plastic Flip-Off button. When selecting a seal to complete your drug package, you should consider the following attributes:

  • Quality of construction
  • Ease of use
  • Tamper evident properties
  • Sterilization compatibility
  • Drug product storage and shipping conditions

In the early stages of component selection, a critical factor is ensuring you are able to maintain container closure integrity over the shelf life of your drug product.
The Flip-Off seal protects
the injection site of the stopper.
Flip-Off seals are easy to use
and provide evidence of tampering.

Major factors that directly affect container closure integrity are the dimensional “stack height” of the vial, rubber closure, seal skirt length and the method of crimping the seal onto the vial container. There are many variables that can affect overall stack height:

  • Vial:
    • Method of manufacture
    • Crown dimensions
      • Outside diameter, crown height and radii
  • Rubber closure:
    • Flange thickness
    • Durometer (the degree of hardness and softness of the material)
    • Finish or films and coatings
  • Seal:
    • Aluminum skirt length
    • Overall height
    • Inside diameter

Determining stack height to select the proper size seal can be a challenge if you are unfamiliar with the construction, variability and make up of container components. A West Representative can guide you through this process by recommending the proper size and type of components to meet your needs. Click here to contact West by phone or by email.

The Flip-Off seal is designed with the end user in mind, making it easy to remove the seal from the vial with one hand. Flip-Off seals provide evidence of tampering and the button cannot be reassembled onto the seal once it has been removed.

 Selecting the correct vial, stopper and seal combination helps assure container closure integrity.

West offers a variety of Flip-Off seals to meet your selected method of sterilization and drug product storage and shipping conditions. Functional and dimensional properties remain constant, with only the base resin of the Flip-Off plastic button changing.

  • Flip-Off seal with a standard homopolymer polypropylene plastic button – autoclavable

  • Flip-Off seal with a copolymer resin plastic button – cold temperature applications for drug products that are stored frozen, refrigerated or packaged product that is shipped on dry ice (-80 °C)

  • Flip-Off seal with a gamma stable resin plastic button – compatible with high energy radiation


Flip-Off seals can be molded from resins suitable for various forms of sterilization and storage conditions.
 

West’s Flip-Off seals are constructed from pharmaceutical grade materials that meet Coalition of North Eastern Governors (CONEG) regulations and current Food and Drug Administration (FDA) recommendations. All manufacturing processes operate in accordance with applicable Current Good Manufacturing Practices (CGMPs).

Flip-Off® Clean Certified Sterile Seals - The Solution for Aseptic Processing
 
Pharmaceutical and biopharmaceutical manufacturers can’t afford to expose their drug products to the risks associated with unsuitable packaging components. This is especially true in today’s manufacturing environment where emerging regulatory guidelines require vial capping operations in a clean room or inside the sterile suite.
 
To help comply with regulatory guidances and to help reduce risk, pharmaceutical and biopharmaceutical manufacturers the world over rely on packaging components designed and manufactured by West Pharmaceutical Services.
 
Now, West has expanded its leadership position with the introduction of Flip-Off® CCS seals – clean, certified, sterilized.
 
Flip-Off CCS seals address pharmaceutical and biopharmaceutical manufacturers’ need for secondary closures used in or near aseptic filling operations. CCS seals are the first in the market to be certified with regard to bioburden and cleanliness. They are designed to be used in a sterile manufacturing environment and are able to meet emerging requirements for capping vials in a clean room.
 
West has developed a production process to control bioburden and particles with established specifications for these attributes.
 
Flip-Off CCS seals are manufactured to the same exacting standards used for West’s Flip-Off seals. They provide excellent machineability on high-speed filling lines and have tamper-evident properties. End-users can remove them easily from the vial.
 
Further, pharmaceutical and biopharmaceutical manufacturers can incorporate anti-counterfeiting protection, cautionary statements and point-of-use instructions on Flip-Off seals by applying West’s proprietary technologies.
 
West manufactures Flip-Off CCS seals in Europe; the seals are available in 13mm and 20mm sizes.
 
Click here to request our Flip-Off CCS Seals brochure. To inquire by email, click here.

 

 

 

 

 

 

 

 

 

 

Flip-Off® and Flip-Off® CCS are registered trademarks of West Pharmaceutical Services, Inc.
SITEMAP | Partnerships | Legal Notice Copyright 2012 West Pharmaceutical Services, Inc.
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