完整性测试仪
各种监管指南要求对无菌溶液（如大容量注射剂（LVP）和小容量注射剂（SVP））处理过程中使用的灭菌过滤器进行完整性测试。Integritest® 5 自动测试仪器可在线或离线对过滤设备进行非破坏性完整性测试，并可灵活地为疏水性过滤器添加配套的 Exact-Air™ II 水基测试装置，从而满足了这一需求。
*EMA 附件 1；FDA 无菌加工 cGMP 指南（2004 年）
Products
Integritest® 5 自动测试仪器
Integritest® 5 使用压力衰减测量来确定过滤器的完整性。在进行系统容积测量的同时，还要进行一次压力衰减测量，以确定扩散和 HydroCorr™ 测试的相关流量。切线法用于在跨膜压力不断增加的情况下，通过一系列压力衰减来确定过滤器气泡点。根据测试参数和持续读数确定最佳测量压力，从而减少了可靠绘制过滤器轮廓和返回准确结果所需的测量次数。
主要功能包括：
- 改进的测试算法，使测试更快、更简单
- 直观的软件，每个步骤都有帮助屏幕
- 灵活的显示、运行信息和测试集合，适合您的流程
- 联网功能，如多单元管理和同步
Exact-Air™ II 疏水性过滤器水基自动测试装置
基于远程容积技术，Exact-Air™ II 系统是一种自动完整性测试装置，其中间容积位于待测过滤器和测试设备之间。
通过使用 HydroCorr™ 测试方法，Exact-Air™ II 系统为用户提供了一个独特的机会来提高空气过滤器测试的可靠性、准确性、可重复性和频率，即使是在极具挑战性的操作条件下。
主要功能包括：
- 带触摸屏显示的用户友好型软件
- 控制填充、测试、排空和就地清洁操作
- 易于验证
- 亲水性过滤器的泡点和扩散测试
相关产品资源
- Datasheet: Integritest® 5
The Integritest® 5 delivers a simple and intuitive user experience, while providing optional depth of flexibility to fit your process.
- Data Sheet: Integritest® 5 Instrument Services
Our IQ/OQ service ensures that the installation and operational qualification of your Integritest® 5 system is fully documented.
- Spare Parts List: Integritest® 5 Instrument
Select and manage the spare parts required for your system, our experts have performed a risk assessment to determine which parts to keep in stock.
- Application Note: Integrity Test Troubleshooting - Beyond Rewet and Retest
The Exact-Air™ II System, paired with the Integritest® 5 tester, uses the HydroCorr™ method, a highly sensitive water-based integrity test for hydrophobic membrane filters.
- Spare Parts List: Exact-Air™ II System
Maintain optimal performance and minimize downtime and manage the spare parts required for your system, our experts have performed a risk assessment to determine which parts to keep in stock.
- Application Note: Integrity Test Troubleshooting - Beyond Rewet and Retest
Integrity testing is a critical operation, especially for sterilizing grade filters used in biopharmaceutical processing. When performed correctly, an integrity test is a fast, definitive, non-destructive way to assure filter retention performance. Fortunately, there are few ways a non-integral filter will pass the integrity test, making it unlikely that a non-retentive filter would not be detected. U
- Brochure: Process Development and Drug Manufacturing
We provide comprehensive services for drug development and manufacturing, including technical and regulatory expertise and process development support.
相关网络研讨会
- Webinar: Defining a Strategy for the Validation and Qualification of Sterile Filtration Processes for Investigational Medicinal Compounds
Investigational New Drug (IND) applications must contain information allowing an assessment of whether or not the product is reasonably safe for initial testing in humans.
- Webinar: Demystifying Bioreactor Contamination Risks
Mitigation of bioreactor contamination risk is complex. People can be lulled into a sense of security that serum-free media eliminates that risk. However presence of contaminants such as mycoplasma can be devastating, leading to extensive investigation and downtime.
- Webinar: Filter Integrity Testing Best Practices
Sterile filtration is commonly employed for microbial removal and plays a pivotal role in assuring final product sterility.
- Webinar: Quality by Design Principles in Aseptic Processing: Have You Minimized Your Sterile Filtration Risk?
In aseptic processing of pharmaceutical products, it is critical that drug products are free from bacteria and other microorganisms to ensure patient safety. Sterilizing-grade filters are commonly used to meet this requirement.
- Webinar: Sterile Filtration Validation Best Practices
Regulations and regulatory guidance for the qualification and validation of sterile filtration processes are specific and well developed.
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