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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.
Take an in-depth look at the science behind containment & delivery of injectable medicines in the West Knowledge Center.
Commitment to the safest and most efficient delivery of drug products requires a detailed understanding of the constantly changing regulatory landscape. Recently West presented a webinar series discussing the current regulatory requirements for packaging/delivery components and systems, to support not only customers, but the industry as a whole. Each averaged more than 300 registrants – clearly showing the interest in these areas.
We recently sat down with Dr. Bettine Boltres, our contact for scientific affairs and technical solutions for glass. In her role she is supporting pharmaceutical companies to address glass-related topics from a scientific perspective and to gain a deeper understanding of the material that holds their valuable drug products. Having done this for many years, we wanted to know what the most frequently asked questions are that she encounters. Please read Part 1 of our two-part series around the 10 most commonly asked questions around glass vials:
Injectable drug products have stringent requirements for the presence of visible particles. However, there is currently no regulatory guidance for visible particles related to packaging components. Instead, specifications are established between suppliers and customers.
As the adoption and acceptance of self-administered therapies grows, patients are spending less time with physicians and are playing a greater role in the delivery and management of their treatments. With the growing demand for extended-release and high-concentration formulations, more drug delivery systems choices are now available to differentiate drug products in a crowded market. Patient preferences can drive the selection of self-injection systems for a drug therapy. Selecting a system that patients prefer can, simplify use and increase compliance with the dosage regimen.
Standing front and foremost in biologic drug formulation is the optimization of safety and efficacy while ensuring quality and stability during manufacturing. Biologic manufacturing subjects the formulation to different stresses and conditions that may compromise quality and stability. Recently, the requirement for the development of subcutaneous formulations for high dose drugs, such as monoclonal antibodies, at high protein concentrations has created additional challenges, including degradation.