Extractables and Leachables USA
E&L USA brings together the complete pharmaceutical supply chain to discuss the latest research in minimizing the risks associated with extractables and leachables.
May 13, 2015, 08:00
May 14, 2015, 16:00
Bethesda, United States
E&L USA brings together the complete pharmaceutical supply chain to discuss the latest news on regulatory updates, results from industry working groups and progress in analysis of new materials for pharmaceutical packaging.
Visit SGS' Booth #9 May 13-14 at the DoubleTree by Hilton, Bethesda, MD and enter for a chance to win an iPad mini or learn more about how SGS can help you with your Extractables & Leachables project.
Dr. Andreas Nixdorf, SGS’ Team Manager Extractables & Leachables Testing will be presenting “The role of material supplier in extractables evaluation of single used systems” on Thursday at 1:55pm.
Several scientific, quality control, and regulatory approaches are used to control and assess the risk of hazardous substances that are inadvertently added to products that humans consume.
The implementation of single used systems (SuS) or other consumables made from plastic continues to expand in biopharmaceutical manufacturing operations. Consequently, an increased level of scrutiny has been placed on suppliers of single used or disposable materials to verify quality, safety and efficacy of their product prior to its use in the pharmaceutical manufacturing process. Suppliers find themselves in a position where end-users expect extractables data. This data is used to assess and mitigate risk involved in the drug manufacturing process and product compatibility, determine leachables in the finished drug products, and establish change controls to support material conformity. Processes need to ensure that the SuS suppliers deliver equal quality over a product’s life cycle time. Nevertheless, drug product manufactures have the ultimate legal responsibility for the safety, efficacy and compliance of the marketed drug product.
Conversely, the supplier of the plastic materials has limited responsibility. In such a partnership between a supplier and pharmaceutical manufacturer, the material supplier would provide the drug manufacturer with information relevant to the assessment of the product´s interaction with the material system. The further one goes back along the supply chain, the information made available by suppliers becomes less useful. This supply chain is highly complex and involves numerous different suppliers. The supply chain is often driven by costs rather than by quality aspects. Thus a process should be established to specify who is responsible for what information. In the absence of clear regulatory guidance, industry best practice is driving toward a standardized protocol for performing extractables studies. Organization such as PQRI, BPSA and BPOG have developed or in the process of establishing such protocols. Standardization strategies are central components applied in industrial processes. In extractables studies, the material evaluation should be customized regarding the intended use of the materials at the end-user side to avoid misconceptions in E&L study design. In that context, the question is, does it make sense to establish standard extractables protocols? Which data packages should be delivered by suppliers supporting their products? What are the advantages and what are disadvantages of the use of standard extractables protocols?
Dr. Kenneth Wong, SGS’ Technical Client Manager will be presenting a poster on “Migration of Ink Components into Transdermal Patches”.
Food and Drug packaging is printed with colorful labels, however, there is limited knowledge about the potential migration of printed ink components into the product. With no global legislation available and ill-defined terminology in the scientific community, formulating ink used in packaging becomes a challenge for suppliers and users who are concerned about potential migration of harmful components. Possible sources of migratable compounds in inks and coatings include UV photo-initiators, mineral oils, and resins. No single analytical method can detect all components in the ink due to the complexity of the composition and solubility of individual components. Hence, the aim of this study is to apply the most effective methods using minimal extraction combined with instrumental analysis to determine the amount of ink components migrating into the contact adhesive layer of a transdermal patch with printing directly on it. The instrumental analytical tests include GC-FID/MS for volatile compounds (benzyl alcohol as ink reducer), UPLC-DAD/MS for non-volatile compounds (polyamide, photo-initiators and their decomposition products) and ICP-OES for metal analysis (D&C Red as color dye).
The calibration curves showed linearity in the range of 0.1 - 5.0 µg/mL for all three instrumental analyses, GC-FID/MS, UPLC-DAD/MS and ICP-OES with r2 no less than 0.998. The limits of detection and the recoveries of individual ink components from extraction samples were 89-102% and 0.2 µg/mL, respectively. The proposed methods will be useful for the quantification of ink migration from the transdermal patch.
SGS is pleased to offer a $200 discount off of the cost of the two day conference to our clients. To register for the conference and receive the discount, use code EL20SGS.