完整性測試機
各種法規要求對無菌溶液處理過程中使用的滅菌過濾器進行完整性測試，例如大容量注射劑（LVP）和小容量注射劑（SVP）。*隨著許多生物製藥廠現在對過濾器進行使用前和使用後的測試，需要快速、可靠和可重複的非破壞性測試方法。Integritest® 5 自動測試儀器可在過濾裝置上執行線上或離線的非破壞性完整性測試，並可彈性增加搭配的 Exact-Air™ II 疏水性過濾器水基測試單元，以滿足此需求。
*EMA附件1；FDA无菌加工cGMP指南（2004年）
產品
Integritest® 5 自動測試儀器
Integritest® 5使用壓力衰減測量來確定過濾器的完整性。在進行系統體積測量的同時，還會進行一次壓力衰減測量，以確定擴散和 HydroCorr™ 測試的相關流量。切線法用於在增加跨膜壓力的情況下進行一系列壓力衰減，從而確定過濾器的起泡點。根據測試參數和正在進行的讀數進行測量的最佳壓力，減少了可靠映射過濾器剖面和返回準確結果所需的測量次數。
主要功能包括：
- 改良的測試演算法，讓測試更快速、簡單
- 直覺的軟體，每一步驟都有幫助畫面
- 彈性的顯示、運行資訊和測試集合，以符合您的流程
- 網路功能，例如多單位管理和同步化
Exact-Air™ II 疏水性濾網自動水性測試裝置
基於遠端容積技術，Exact-Air™ II 系統是一個自動完整性測試裝置，它的中間容積位於待測過濾器和測試裝置之間。
通過使用 HydroCorr™ 測試方法（一種針對疏水性膜過濾器的高靈敏度水基完整性測試），Exact-Air™ II 系統為用戶提供了一個獨特的機會來提高空氣過濾器測試的可靠性、準確性、再現性和頻率，即使是在具有挑戰性的操作條件下。
主要功能包括：
- 具備觸控螢幕顯示的使用者友善軟體
- 可控制充填、測試、排空和就地清洗作業
- 易於驗證
- 親水性過濾器的泡點和擴散測試
相關產品資源
- 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.
相關網路研討會
- 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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