Sartocheck® 5 Plus Filter Tester
Keeps Your Risk Factors Under Complete Control
The Sartocheck® 5 Plus perfectly meets today’s key industry requirements for filter integrity testing in demanding GMP environments. By combining a unique approach to Quality Risk Management, with optimal data integrity, intuitive usability and minimized risk factors for Health, Safety and Environment (HSE), it sets a new standard for filter integrity testing devices.
Surpass the Requirements of Quality Risk Management (QRM)
The regulatory focus on QRM (cf. ICHQ9 and the new Annex 1 written by EMA in cooperation with the US-FDA, WHO and PICs) also applies to filter integrity testing, as a fundamental element of sterility assurance.
The Sartocheck® 5 Plus Filter Tester uses program specific parameters allowing the automatic identification of testing anomalies in advance or during the test. This avoids time-consuming and costly deviations, potential drug recalls and 483 warning letters.
More Information:
Reach the Ultimate Level of Data Integrity
Filter integrity test values are part of the batch protocol and are used to justify the drug release. Long term reliable data is therefore crucial to avoid quality deviations and potential FDA 483 warning letters. The integrity and security of filter integrity test data must therefore not be seen only as an IT problem but also as a potential global business risk. Low standards of data integrity & security may not only jeopardize the activities of the drug manufacturing company, but what is more critical, endanger the health of patients
Experience the Comfort of Intuitive Usability
An optimal user experience speeds up process workflows due to intuitive guidance and ease of use. The high quality touchscreen of the Sartocheck® 5 Plus Filter Tester provides a unique viewing angle, an intuitive user interface, a logical menu structure, and simple data entry options. This allows straightforward programming of tests and QRM enhancement features, as well as error-free operation in GMP production environments.
Discover the Simplicity of Health, Safety, and Environment (HSE)
Integrity testing often involves the use of chemicals and hazardous materials. The Sartocheck® 5 Plus is certified for use in explosion hazardous areas (ATEX) and is compatible with all current cleaning agents and VHP. This ensures maximum safety for operators and manufacturing facilities.
Filter Integrity Testing Webinars
Software & Accessory Upgrade Overview
Software Upgrade Q2 2022 - Version 2.1.1
Data Integrity
- New root file system – Higher security
- Blocking of abusive test repeats (e.g., max 3 tests per filter)
- Mandatory Why Comment when modifying programs
HSE | OSH (Health Safety & Environment | Occupational Safety and Health)
- Fully automated cleaning function (software)
- Accessory kit for automated cleaning – Not included in the upgrade
Usability
- Flexible entry of diffusion values for TFF cassettes (max 4,800 mL/min)
- Scheduled exports of Audit Trail PDFs
- Improved overall stability
Software Upgrade Q2 2021*
Data Integrity
- Audit trail GUI improvements (readability)
- Traceability improvements in the audit trail
- Consistent file names
- Harmonized time representation
- Additional time formats
- Possibility to modify the default Admin
- No empty fields on the calibration certificate
Usability
- Memory management
- Remote administration via OPC UA
- Printing via a printer server
- DNS name support
- Error codes on the screen
- Automation improvements
Software Upgrade Q4 2020*
Audit Trail Filtering and Exports
The audit trail has been further improved by the possibility to use cumulative filtering of the displayed audit trail events. The audit trail can now be exported to as a digitally signed and write-protected PDF format. All relevant information is clearly written on the header of the exported audit trail, such as the time of export, the name of the user who exported, and the serial number of the Sartocheck®️ 5 device. If filters are applied to the PDF export, they will undoubtedly also be written in the header and all pages of the audit trail will be identified by file name and pagination to ensure the highest level of data integrity.
OPC UA Automation Improvements
For maximum flexibility, it is now possible to start an existing program by name.
*Please note that all software upgrades are cumulative, i.e. the latest version includes all upgrades from previous versions.
Accessory Upgrade Q4 2020
Test Tubings
The optional test tubings of 5 and 15 meters will be available shortly. Just like the two-meter standard tubing, they have been leak-tested individually. They also come with a specific data sheet with recommendations for use.
Software Upgrade Q2 2020*
Automation Using OPC UA or Modbus TCP
OPC UA and Modbus TCP are two commonly used industrial automation protocols. Compatibility with other control protocols for automation networks such as DeviceNet, Profinet, etc., can be achieved by using third-party gateways.
Additional Keyboards
The additional keyboards of Korean and Cyrillic give a total of 10 frequently used languages.
LDAP Group-Based Role Management
Users can be conveniently managed directly on the LDAP server without the need to modify the Sartocheck®️ 5 Plus.
Serial Number of the Device in Every Audit Trail Entry
All GMP-relevant actions contain the serial number of the device and are reliably time-stamped and can be traced back to a specific device.
*Please note that all software upgrades are cumulative, i.e. the latest version includes all upgrades from previous versions.
Downloads:
Quality Risk Management Handbook Conducting FMEA Using the Sartocheck® 5 Plus Filter Tester
PDF | 644.3 KB
Sartocheck® 5 Plus Filter Tester - New Software Release Q1 2023 - Version 2.2.1
PDF | 2.7 MB
Sartocheck® 5 Plus Filter Tester - Keeps Your Risk Factors Under Complete Control
PDF | 659.0 KB
