我们关注质量、患者安全和准时交货. Partner with our experienced team for 可萃取物和可浸出物测试 to identify harmful impurities and eliminate potential risk to end-users. 在一起, we'll ensure regulatory compliance through a risk-based approach to extractables and leachables studies.
什么是可提取性和可浸出性测试?
可推断出的 and leachables testing is a critical need required by manufacturers of pharmaceutical, 医疗设备, 生物, 风险降低, 组合产品, to identify and assess the risk of human exposure to potentially harmful impurities migrating from a polymeric materials.
可推断出的 testing involves the use of aggressive laboratory conditions to extract compounds, 这使我们能够评估风险并提供有关材料适用性的指导. 可推断出的 studies provide a "early indication of potential risk" to support you with materials selection and product development.
Leachables testing detects chemicals that migrate into the product or to the patient under typical-use conditions. 可浸出性研究测试成品药品或成品医疗器械.
与我们合作提供可提取和可浸出测试服务的主要好处
- 保障病人安全: Using accurate extractables and leachables test data to determine potential risks to patients and ensure end-user 安全.
- 高质量结果: Choose one of the world's most experienced extractables and leachables providers delivering industry-leading solutions.
- 符合法规要求: 导航最有效的遵从性路径.
- 加快上市时间: Facilitating the swift and efficient completion of 可萃取物和可浸出物测试 programs to ensure timely market entry.
- 复杂研究方案理解: 提供对可接受的协议和报告的深入理解, 这对避免提交监管文件造成代价高昂的延误至关重要.
- 定制的研究: 对各种复杂产品和矩阵进行定制研究, 与适用参数的监管期望保持一致.
- 专业知识和经验: 经验丰富的专家团队 由全球可萃取物和可浸出物测试站点网络提供支持.
为什么可提取性和可浸出性研究很重要?
可推断出的 and leachables studies determine whether potentially harmful organic and inorganic impurities - that can alter product 安全 or efficacy - have migrated into a finished product from various sources such as container closure systems, 制造和工艺设备, 包装, 输送设备或医疗设备.
检测对于确保患者安全至关重要, 加快上市时间, 保持药品的法规遵从性 & 医疗产品开发和生命周期管理.
我们擅长有效地进行可萃取物和可浸出物的研究, 医疗设备, 生物, 风险降低, 组合产品, to ensure patient 安全 and offer comprehensive solutions based on industry-leading practices. im体育APP的团队 了解更多信息.
法规遵从和风险管理
我们的 regulatory and scientific experts support the world’s leading healthcare brands in establishing the 安全 of products for patients. 监管机构(包括FDA)的期望, 教育津贴, MHRA, 加拿大卫生部)不断发展, demanding increasingly strict criteria for assessing the materials of new drug products or 医疗设备s.
By partnering with us for your extractables and leachables studies you'll stay up to date with changes in guidelines and industry requirements. We perform 可萃取物和可浸出物测试 that provides the data needed for your regulatory submission. 我们的科学家利用监管专业知识, 数十年的经验, 以及一个强大的可提取和可浸出程序, to evaluate potential risks and navigate a swift and efficient pathway to regulatory approval.
独特的挑战需要深入的知识
当你选择了im体育APP，你的挑战就变成了我们的挑战. Partner with us to share our 数十年的经验 developing and executing extractables and leachables programs, 业界最大的可提取数据库之一, and the confidence that complex material assessments to toxicological evaluations are performed to the highest standards.
We have extensive experience testing a wide range of complex products including combination products, OINDP设备，细胞和基因治疗 和更多的. 我们的 experts possess a deep understanding of ISO 10993-18 (a primary source of regulatory information for combination products and 医疗设备s), 正确评估需求并成功设计 & 提供全面的可提取性和可浸出性测试程序.
代价高昂的延误和商业影响
The primary goal of extractables and leachables studies is to ensure patient 安全 by identifying potentially harmful impurities. Failure to conduct appropriate testing may result in harmful organic and inorganic substances migrating into the finished product, 危及安全, 有效性, 商业上的成功.
为了高效的商业流程, 在早期临床开发中，可提取物和可浸物的资格是至关重要的. 全面了解可接受的协议和报告也很重要, 遵循错误的研究方案可能会导致代价高昂的延误.
可提取和可浸出测试服务
- Customized extractables and leachables study designs according to industry best practices and regulatory guidance
- Compliance with USP <665>, USP <1665>, and BPOG protocol
- Development of extractables and leachables materials risk assessments and strategy documents
- 药品容器封闭系统(CCS)的材料选择
- 药物和容器封闭相容性研究
- 对照提取研究
- 完成方法开发和验证程序
- 可提取和可浸出鉴定
- 可浸出稳定性研究
- 毒理学安全评估
- Comprehensive materials characterization and leachables risk evaluation according to ISO-10993 parts 18, 12和17
- 呼吸气体通路的生物相容性分析
- 现场培训和咨询项目
为什么选择im体育APP?
Partnering with us for 可萃取物和可浸出物测试 safeguards patient 安全 through accurate test data and delivering high-quality results. 作为世界上最有经验的供应商之一, 确保法规遵从效率, 加快上市时间, 理解复杂的研究方案, 进行定制研究, 并提供在该领域广泛的专业知识和经验.
我们的 专业团队 多年来对im体育平台app下载有直接贡献吗, 积极参与制定PQRI的几个工作组, USP专家小组, 埃尔希, CEN和ISO可提取和可浸出的最佳实践.
更多关于我们的可萃取物和可浸出物研究和咨询服务的信息, 或者要求报价, 立即im体育APP.
可萃取物和可浸出物研究过程
回顾研究中涉及的所有材料，以确定研究范围.
使用适当的溶剂提取可能是可浸出物的化合物.
通过可提取和可浸出的研究确定对患者的毒理学风险.
Quantitate harmful leachables in the final product to determine the actual risk that they pose.
Provide detailed feedback to help clients comply with standards and reduce the likelihood of delays to market.
生命科学
查看我们的生命科学思想领导力内容，包括网络研讨会, 白皮书, 案例研究、博客等等.
由我们的im体育平台app下载专家撰写, 我们处理抗菌领域的一系列课题, 生物技术食品, 医疗设备, 制药, 和个人护理im体育平台app下载.
带着对绝对确定性的承诺, we utilize our extensive expertise and experience to provide insights that ensure the 安全 of materials used in the life science sector.
im体育官方app下载相关服务
可推断出的 & 监管指导服务
im体育APP provides regulatory guidance services for extractables and leachables to ensure that medicines are of the required quality, 安全, 和有效性.
可推断出的 & 培训服务
im体育APP’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.
简化可推断出的 & 可浸出物测试协议
im体育APP helps you design effective and efficient 可萃取物和可浸出物测试 protocols to meet the risk-based approach and industry regulations.
ISO 18562测试:生物相容性分析
im体育APP provides ISO 18562 biocompatibility analysis for respiratory and ventilation devices to support global device approval.
按需网络研讨会:E&L定制注射器交付的注意事项
Dr. 詹姆斯划船, im体育APP生命科学科学主任, 讨论了一个案例研究，探讨了E&L考虑定制给药系统以满足法规要求.
CMC产品开发服务
我们的CMC产品开发服务包括配方开发, 注射和外用产品开发, 微生物检测服务, 和咨询公司.
化学，制造和控制(CMC)咨询服务
我们提供化学咨询服务, 制造业, and Controls (CMC) product development in the pharmaceutical and biotechnological industries.