过滤器验证
服务

制药和生物制造的验证服务

在竞争激烈的制药行业中，MTS（迈斯纳技术服务）可以为您的员工提供成功所需的技术优势。

我们通过加速满足客户过滤和一次性系统技术和验证要求的解决方案，帮助客户加快新产品和现有产品上市。

每天与制药行业的接触为MTS员工提供了对行业及其过滤需求的实用理解。我们的经验转化为无与伦比的客户服务，使客户能够实现最佳过滤性能，同时仍满足经济和合规标准。MTS可以提供完整的验证包，准备好接受FDA或其他机构的审查，包括书面和现场支持。

服务手册

过滤器验证服务

Download PDF

MTS验证专家

MTS验证专家为每个独特的客户制定最有效的测试协议，提供完整的验证指南和文档包，甚至进行员工培训。客户支持可以在我们自己的实验室或客户设施内进行。

我们的测试和验证协议根据最新的行业标准设计，并根据每个客户独特的液体和工艺条件集量身定制。它们详细说明了要执行的测试、控制措施以及为确保所有测试设备设计合理且测试方法科学可靠而进行的预验证测试。用于测试的任何缩放计算也会详细说明，以清楚地展示测试工作如何与用户流程相关。所有协议在工作开始前均由各方批准。

迈斯纳的MTS验证小组提供完整的报告、建议和文档，交付时间比任何过滤器制造商都要短。迈斯纳技术服务通常可以在一个月内完成验证并提供完整报告，始终比我们的竞争对手更快。

领先的MTS验证服务

MTS microbiologists are experts in sterile filtration, mycoplasma removal, and virus removal. Fully equipped MTS laboratories perform microbial-challenge studies on customer products, under worst-case processing conditions, using bioburden-specific organisms or standard challenge organisms.

Microbiological Services

A critical analysis of potential interactions between filter components and the pharmaceutical product is performed to ensure that the filter experiences no adverse effects in the pharmaceutical product.

Compatibility Screening

Integrity test values are established from testing conducted with actual product; test values are based on the customer’s preferred test methodology, including bubble point, diffusion, or pressure hold and are carefully established and documented.

Product-based Integrity Testing

All pharmaceutical filters are shipped with certificates of quality with release data. This helps customers meet FDA or other agency documentation requirements, facilitates incoming materials handling, and minimizes the need for testing by customers.

Filter Quality Certification Program

MTS generally performs filter retention studies on pharmaceutical product, under extended processing conditions. This includes protocol development, viability and inhibition testing, and the challenge using either standard challenge microorganisms or bioburden-specific organisms.

Microbial Retention Studies

A gravimetric non-volatile residue (NVR) determination is made for the model solvent; additional GC-MS analysis is performed on the extract.

Extractables Testing

MTS staff can visit customers onsite to perform technical reviews, document and analyze system performance, and help ensure regulatory compliance.

Filtration Process Reviews

Upon request, MTS can supply information on materials of construction, challenge protocols, performance data, sterilization protocols, and integrity test values using the customer’s preferred method.

Additional GMP Documentation