完整性测试仪
各种法规准则都要求对无菌溶液处理中使用的灭菌过滤器进行完整性测试，例如大输液（LVP）和小输液（SVP）。*现在许多生物制药制造商在使用前后都需要对过滤器进行测试，因此亟需一种快速、可靠且可重复的无损测试方法。Integritest® 5自动化测试仪可通过在线或离线在过滤设备上进行无损完整性测试来满足这一需求，并且可以为疏水过滤器灵活地添加配套的Exact-Air™II水性测试装置。
*EMA附录1；FDA无菌工艺cGMP指南(2004)
Integritest® 5自动化测试仪
自25年前推出首款商业自动化完整性测试仪以后，我们推出了最新的型号Integritest® 5，其使用压力衰减测定来确定过滤器的完整性。除了系统体积测量外，该仪器进行一次压力衰减测量即可确定扩散和HydroCorr™测试的相关流量。其采用切线法，根据在跨膜压力增加时执行的一系列压力衰减来确定过滤器的起泡点。最佳的测量压力可基于测试参数和持续的读数获得，从而减少了获得可靠绘制过滤器轮廓并返回准确结果所需的测量次数
其主要特性包括：
- 改进的测试算法，可实现更快、更简单的测试
- 直观的软件，每一步都配有帮助页面
- 提供有灵活的显示、运行信息和测试组合，满足您的工艺要求
- 网络功能，例如多单元管理和同步
用于疏水过滤器的EXACT-AIR™II自动水性测试装置
Exact-Air™II系统基于远程容积技术开发，是一种自动完整性测试装置，中间容积位于要测试的过滤器和测试设备之间。该装置可与Integritest® 5测试仪配套使用，在极端关键的温度条件下提高测试准确性和可重复性。
通过使用HydroCorr™测试方法（用于疏水性膜滤器的高度灵敏的水性完整性测试），Exact-Air™II系统即使在充满挑战性的工作条件下，也能提高对空气滤器测试的可靠性、准确性、可重复性和频率。
其主要特性包括：
- 带有触摸屏的人性化软件
- 控制灌装、测试、排水和在线清洗操作
- 易于验证
- 亲水过滤器的起泡点和扩散测试
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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