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Ensuring the sterility of sterile medicinal products has always been one of the key concerns of drug manufacturers, due to the dire health implications it could have on the patients, as well as the potential for costly product recalls. The importance of control strategies to ensure sterile drug products has also been reiterated by regulatory agencies such as the U.S. Food and Drug Administration (FDA) and The European Medicines Agency (EMA) in their respective guidelines: <br /><ul><li>FDA – Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice</li><li>EU GMP Annex 1 Manufacture of Sterile Medicinal Products</li></ul>
Innovation in manufacturing involves a spectrum of evolutionary improvements resulting in what West’s partner Daikyo Seiko, Ltd. considers as “Absolute Quality.” Recent continuous improvement efforts from Daikyo focused on the manufacturing environment, including a move from ISO 8 to ISO 7 cleanrooms and 100% automated vision inspection with enhanced inspection limits. The result helped Daikyo achieve even higher levels in cleanliness of elastomer products.<br />
<p><em>A scientific poster by: Clara Goodfield, Eugene Polini, Amy Miller and Wayne Curry</em></p><p><em>The ideal sterilization process destroys all microorganisms rapidly with minimal adverse impact on the chemical and physical properties of the elastomeric closure. Developing and validating an acceptable sterilization process is critical to the drug product quality. This study served to help understand the potential deterioration of physical and chemical properties, the possible impact to functionality and the potential changes to the extractable/leachable profile as a result of sterilization</em></p>
For injectable drug product package systems, seals are considered to be secondary package components. Though not in direct contact with drug products, they perform critical functions such as: Maintain an integral sterile seal by holding the stopper firmly in place, protect the injection site on the stopper and provide evidence of tampering (dependent on seal design).
Diane Paskiet, Ph.D., Director of Scientific Affairs, will present “Biopharmaceutical Quality: Factoring Extractables into the Risk Equation” at Cambridge Health Insitute’s 14<sup>th</sup> Annual PepTalk 2015 conference on January 22-23, in San Diego, CA. The program, which was co-developed by Thomas Egert, Research Scientist, Boehringer Ingelheim GmbH & Co. KG, will focus on risks to quality posed by materials that contact biologics during manufacturing, storage and those associated with the final packaging configurations can pose risks to quality.
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