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 Q2 2024: Improved Data Integrity and Usability. New Cleaning Feature

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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.

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.

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.

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.

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Webinar - The Regulatory Environment of Filter Integrity Testing

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

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Software & Accessory Upgrade Overview

Upgrade Q2 2024

Testing & Performance Upgrade Q2 2024 – Version 2.3.2

Bubble point pressure stabilization (no change in the testing algorithm)
Improved data export performance
Double backup of calibration data
Improved keyboard Pinyin-function (Mandarin)
Stability improvements

Upgrade Q1 2023

General Performance Upgrade Q1 2023 – Version 2.2.1

Stability improvements
Audit trail improvements
Connectivity improvements
Cleaning cycle improvements (CCS)

Upgrade Q3 2022

Accessory Hardware Upgrade Q3 2022

Contamination Control Strategy (CCS)

Accessory Kit allowing cleaning of the internal pneumatics with up to 0.5M NaOH at 50 °C.
Recommended standard cleaning at room temperature with 0.1M NaOH.
Combined with the Accessory Kit for external venting, the Cleaning Kit is part of a comprehensive CCS of the Sartocheck^® 5 thus fulfilling the most stringent expectations of Annex 1 compliance.

Upgrade Q2 2022

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

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Quality Risk Management Handbook Conducting FMEA Using the Sartocheck^® 5 Plus Filter Tester

PDF | 597.4 KB

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