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元素’s extractables and leachables studies offer tailored solutions that shorten time to market and ensure patient safety and the sustainability of your pharmaceutical and medical device products.
Studying the impact of extractable and leachable substances on safety and drug product interaction is of utmost importance to protect the patient and comply with regulations. Leachable materials may originate from pharmaceutical container closure systems, process equipment or medical device packaging, and go on to contaminate the drug before consumption.
Element的E＆L团队使用行业领先的专业知识，深入了解材料和监管要求，以帮助客户评估可浸出的潜力，制定评估风险的策略，并提供基于风险的支持数据集yabo娱乐vip。
通过毒理学yabo娱乐vip评估，萃取物和鹿浸渍测试和之间的一切，元素支持世界领先的医疗保健品牌，以建立患者材料的安全性。
Extractables and leachables study programs
- Container closure systems (CCS), including combination products
- Single-use manufacturing equipment, including BPOG protocol
- Implantable medical devices
- Drug delivery and infusion systems
Our advanced equipment, in-depth knowledge of materials and regulations result in the efficient and successful completion of E&L testing programs for pharmaceutical packaging and manufacturing equipment.
Extractables and leachables study services
- Material selection for pharmaceutical container closure systems (CCS) and medical devices
- Customized E&L study designs developed according to the latest industry best practices
- 完整的方法development and validation programs
- 毒理学安全评估
- Development of E&L materials risk assessments and strategy documents suitable for regulatory submission
- Comprehensive materials characterization and leachables risk evaluation according to ISO-10993 parts 18, 12, and 17
- On-site training and consulting programs
我们将我们的良好制造业实践（CGMP）与多年的经验和最先进的检测设备相结合，以提供高效和成功完成药品包装，制造设备和医疗设备的E＆L测试程序。
The Element advantage
元素's laboratory complies with Good Manufacturing Practice (cGMP) guidelines. Our team of Engaged Experts have been active participants in several working groups that have developed the PQRI, USP Expert Panels, ELSIE, and BPOG extractable and leachable best practices.
Our extractables and leachables studies help make certain the quality and effectiveness of the drug product are maintained at all times, in all circumstances, while at the same time meeting all relevant regulatory requirements.
For more information about our extractables and leachables studies or to request a quote,contact us today.
Our Services
Services
萃取物和脱色物监管指导服务
元素provides regulatory guidance services for extractables and leachables to ensure that medicines are of the required quality, safety, and efficacy.
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Services
Extractables & Leachables Training Services
元素’s extractables and leachables training services address a wide range of topics in the industry to keep you up-to-date with the ever-changing regulations.
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services
Extractables & Leachables Testing Reports
元素’s extractable and leachable testing programs are accompanied with clear, concise and accurate test reports.
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Streamlining Extractables & Leachables Testing Protocols
元素helps you design effective and efficient extractables and leachables testing protocols to meet the risk-based approach and industry regulations.
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providing certainty for nearly 190 years
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services
Excipient Raw Materials and Container Testing
元素具有综合功能，可应用于赋形剂，原材料和制药容器的测试，使您能够确保产品的质量和安全性。yabo娱乐vip
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services
Medical Product Testing
With a clear understanding of your markets, regulations, and challenges, we provide our expertise and experience with cGMP, GLP, ISO/IEC 17025 testing to help your product reach the market sooner and with safety and quality built in.
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Resource
USP <761> Qualitative and Quantitative NMR Analysis
Cathy Moore，Ph.D.，在此免费录制的网络研讨会中提供了NMR光谱的概述，以帮助您更好地了解该方法的技术，数据输出和功能。
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SERVICES
Microbiological Development and Quality Control Testing
Our microbiology lab provides microbiology testing services and quality control for a variety of drug products, ensuring they are safe, quality, and compliant with relevant regulatory standards.
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