Webinar: The Regulatory Environment of Filter Integrity Testing

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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.

Upcoming Filter Integrity Webinar

Join Magnus for his Webinar on The Regulatory Environment of Filter Integrity Testing

October 30 | Get an overview of the regulatory requirements for filter integrity testing and learn how the Sartocheck® 5 Plus Filter Tester can contribute to regulatory compliance!

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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 users to enter a specific expected volume range for each individual program.

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.

Supplied 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

Devastating malware incidents and the continuing threat of computer-related virus infections have created an urgent need for data protection and security. The completeness, consistency and accuracy of data during its entire life-cycle are critical aspects of regulatory compliance in all systems that generate, store and retrieve it. The customized Linux Operating System and write protected root file system of the Sartocheck® 5 Plus, along with the unalterable data formats associated with test results and audit trail, protect against malware and virus infections, ensuring data integrity is always preserved.

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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 for log on with Windows credentials

The Sartocheck® 5 Plus supports Lightweight Directory Access Protocol (LDAP) which allows all operators to utilize their network credentials to access the device.

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 (September 2019 free upgrade)

The Sartocheck® 5 Plus uses Modbus TCP protocol which is a commonly used industrial automation protocol and is compatible with other automation network control protocols.

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.

Downloads:

Brochure: Sartocheck® 5 Plus Filter Integrity Tester

PDF | 8.4 MB

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Datasheet: Sartocheck® 5 Plus Filter Integrity Tester

PDF | 974.0 KB

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