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.

Upgrade Q4 2020: New Audit Trail and OPC UA Features
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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.

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Automatic detection of improper test setups

The Sartocheck® 5 Plus Filter Tester allows the administrator to enter a specific expected volume range for each individual program. A measurement outside the range will automatically abort the test.

Automatic detection of abnormal test conditions

If a pressure increase is detected instead of a pressure decay, it may indicate a temperature change or that the downstream side of the filter is being pressurized.

Available comprehensive FMEA documentation

The aim of the Sartocheck® 5 Plus FMEA is to identify operator hazards, risks of false passed and false failed test results and perils for the functionality of the device.

Calculation tool for unlikely pressure reading deviations

The evaluation tool for the Sartocheck® 5 is based on theoretical calculations that have been confirmed by empirical studies on intentionally de-calibrated integrity test devices.

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

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Electronic signatures | 4 eyes principle

Electronically signing test results according the 4 eyes principle further enhances the trustworthiness of data.

Audit trail with time zone synchronized (NTP) events

All GMP relevant actions are time stamped in the audit trail to comply with 21CFR part 11. When parameters are changed, before and after values are displayed so that full traceability is shown.

Custom Linux-based OS with SSB custom architecture

The Sartocheck® 5 Plus Filter Tester uses a custom Linux-based OS with Sartorius Stedim’s own custom architecture to provide inherent protection against virus and malware attacks.

Write protected and constantly monitored root file system

The write-protected root file system makes it impossible for a virus to reside in the system. The integrity of the root file system is constantly monitored and any change would be recognized and lead to a software recovery.

Encrypted double data backup on internal inaccessible SD card

All data generated is instantly backed up on an internal inaccessible 8 GB SD card. This prevents any loss of data, even in the unlikely event of system crash or if the Sartocheck® 5 Plus is dropped or damaged.

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.

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Large touch screen (12.1”) with great viewing angle (+ | -88°)

A large bright screen with a great viewing angle contributes to ease of use, regardless of the operator’s height and position.

LDAP group based role management

Users can conveniently be managed directly on the LDAP server without the need of intervention on the Sartocheck® 5 Plus.

Easy data transfer

The generated data by the Sartocheck® 5 Plus can be conveniently transferred by file directory shares via Ethernet cable or Wi-Fi (optional Nano router).

Automation using OPC UA or Modbus TCP

Automation integration is easily achieved with two commonly used communication protocols. User manuals are available.

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.

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High ingress protection IP64

The Sartocheck® 5 Plus is designed for IP64-compliance to perform under the most stringent conditions in wet environments such as filter preparation.

Ex-proof (ATEX|IECEx|FM) for safe testing of alcohol wetted filters

The Sartocheck® 5 Plus is the only explosion proof filter integrity tester device on the market.

Resistant to all current cleaning agents and H2O2 (VHP)

The Sartocheck® 5 Plus is the only VHP compatible filter integrity tester on the market.

Accessory kit for external venting prevents backflow

The optional Accessory Kit for external venting consists of a venting valve and a blocking valve and includes a pressure sensor that is identical to the one used inside the Sartocheck® 5 Plus.

Filter Integrity Testing Webinars

Webinar - The Regulatory Environment of Filter Integrity Testing

Watch Webinar Online

Reach the Ultimate Level of Data Integrity with Sartocheck® 5 Plus

Watch Webinar Online

Software & Accessory Upgrade Overview

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.


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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 | 727.8 KB

Brochure: Sartocheck® 5 Plus Filter Tester

PDF | 4.2 MB

Datasheet: Sartocheck® 5 Plus Filter Tester

PDF | 969.7 KB

Article: Addressing Regulatory Requirements for Filter Integrity Testing

PDF | 543.7 KB

Article: QRM for Filter Integrity Testing – Complying with EMA's Future Annex 1

PDF | 247.9 KB

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