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The glass transition temperature (Tg) is the temperature at which a material loses its viscoelastic properties. It is also indicative of the lowest temperature at which the polymer system will retain its functionality.
The typical Tg for polymer used in the general industry is approximately -50oC. For drug product that requires storage at cold temperature, below the Tg of the rubber, the hard surface of rubber would be seated against the hard surface of glass. This may affect the container-closure integrity (CCI), causing a potential for microbial ingress and gas headspace exchange. Customers should perform proper functionality testing of the stopper with emphasis on seal integrity on the product package intended for storage at these temperatures. Currently, there is no test method available for CCI at -80oC. The typical approach is to prove CCI and sterility prior to storage below -80oC. Rubber has ‘memory’ and so it is recommended for retest after bringing back to ambient to prove no impact to CCI or sterility .
In addition, the Tg of the PP buttons used on the Flip-off seals is approximately -20oC. Below which, premature removal of button may occur during shipping. West offers ‘copolymer’ buttons. Copolymer is a more robust material and limits early activation of button during shipping. Copolymer seal is made of PP with small amount (<10%) of PE added. PE helps the seal from becoming brittle during cold storage. The copolymer seal performs at -80oC. Further investigation would be required for storage below -80oC using the copolymer seal.
West offers packaging components tested to be suitable for cold temperature storage (-80°C or dry ice) and for transport in dry ice. Please contact your account representatives for more information for the appropriate recommendations.
Uninterrupted production on a high-speed filling line is a challenge. To help make this easier, West has developed Flip-Off<sup>®</sup> seals. Flip-Off seals are produced with the highest quality aluminum and plastic materials, and the TruEdge<sup>®</sup> manufacturing process.
Each June, West recognizes Pride Month, which promotes and supports the self-affirmation, dignity, equality, and increased visibility of the Lesbian, Gay, Bisexual, Transgender and Queer or Questioning (LGBTQ) community.
The supply of sterile pharmaceutical closures into a filling line is an essential element of the production of parenteral drug products. In addition to sterilizable bags, West offers closures in aseptic transfer bags – referred to as “port bags” or “ported bags.” Port bags contain a “beta” port that is attached to the actual bag <strong>(Figure 1).</strong>
Allergy to natural rubber latex was first documented in the late 1970s. The condition now commonly known as “Latex allergy” is caused by the proteins produced from the rubber tree (Hevea brasiliensis) that are still present in the products manufactured from natural rubber latex. This allergy is not only caused by the proteins, but also by the chemicals and/or residues thereof.
Vaccines have helped reduce the instance of infectious diseases around the globe, nearly eradicating past plagues, such as smallpox and polio. A very effective method of delivery is intradermal (ID) injection – now made easier with two novel products on the market.
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