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Electron-beam irradiation (e-beam - sometimes called beta irradiation) is a technique used commonly to sterilize pharmaceutical packaging products and medical devices. It operates by directing a continuous flow of electrons through the articles being sterilized. Transfer of energy from the e-beam breaks the chains of DNA in organisms, rendering them inactive, and the articles irradiated as sterile. It is used typically for Ready-to-Use (RU) vials and syringes comprising Daikyo Crystal Zenith® cyclic olefin polymer, and Daikyo PLASCAP® seal products.
E-beam sterilization has many advantages; it is convenient, gentle and effective. E-beam sterilization can be performed continuously on product in its final package (e.g., product supplied in nests used in flexible fillers). Compared to steam sterilization, it operates at a much lower temperature, and is suitable for products having hard-to-reach areas (e.g., capped cartridges). Compared to gamma irradiation, it poses a much lower risk of degradation (due to shorter exposure times); compared to ethylene oxide exposure, it eliminates the risk of ethylene oxide absorption and subsequent leaching into drug product.
A point to note is that e-beam sterilization can cause a temporary discoloration (yellowish tint) in polymer products, including Daikyo Crystal Zenith® cyclic olefin polymer products. This is due to the presence of short-lived free radicals. However, after the quenching of these radicals, there is no resultant risk to drug product, and in particular, biologic products.
For more information on West products, or how e-beam sterilization can be successfully employed for packaging products, visit the Knowledge Center or contact your Account Manager, or Technical Customer Support representative.
Daikyo Crystal Zenith® and PLASCAP® are registered trademarks of Daikyo Seiko, Ltd.
Daikyo Crystal Zenith® technology is licensed from Daikyo Seiko, Ltd.
<a></a><a href="/news-and-events/virtual-events">Register</a> today for West’s free educational series <strong style="color: #333333;">“Supplying Safe Medicines to Patients: Considerations for Container Closure and Delivery Systems”</strong><span style="color: #333333;"> on October 30, 2013, at the Westin San Diego Gaslamp Quarter hotel.</span>
<span style="color: black;">The final week of the Ambassador Internship program is coming to a close, and the 31 students who have been hard at work since June now have the opportunity to showcase what they have learned and reflect upon the entire experience during the program wrap-up. </span>
Recently, there has been increased scrutiny from regulatory authorities to quantify and qualify subvisible particles in biopharmaceutical products. Such particles, which can cause a protein to denature, are of concern to pharmaceutical manufacturers since they can affect the efficacy of the drug product. As regulatory bodies continue to raise the bar on quality, industry is looking for “zero defect” and particle free components as well as a way to minimize quality variation.
The combination product market has seen a significant amount of growth,<sup>i</sup> driven primarily by the rise in chronic disease indications, the demands for self-administered therapies and technological advancements. The use of combination products simplifies the process of drug administration for the patient and/or the caregiver and, in some cases, allows the patient to receive treatment at home rather than having to travel to a medical facility. However, there are many challenges that need to be navigated as one considers the transition from a vial system to a needle-based combination product.
The Tech Group’s Keith Calvert recently contributed a three-part blog on metrology to Medical Design Technology. The following is from Part 3.
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