Sartocheck® 5 Plus Filter Tester New Software Release Q2 2021

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. It sets a new standard for filter integrity testing devices, allowing you to: Surpass the Requirements of Quality Risk Management (QRM) Reach the Ultimate Level of Data Integrity Experience the Comfort of Intuitive Usability Discover the Simplicity of Health, Safety, and Environment (HSE) Quality Risk Management Automatic detection of improper test setups Automatic detection of abnormal...

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 of or during the test. This avoids time-consuming and costly deviations, potential drug recalls, and 483 warning letters. The bubble point programs can be defined with a minimum flow expected...

Automatic Detection of Abnormal Test Conditions From a Pressure Increase When a filter is being tested, it always generates a certain pressure decay. 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. Prevention of Irregular Test Repeats (Roadmap) It is generally recommended that a filter should be tested a maximum of three times at the user’s site (cf. PDA Technical Report 26 and PDA Points To Consider Part 2 Topic K). If more tests are required to get a test pass, the integrity...

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 crucial to avoid quality deviations and potential FDA 483 warning letters. The integrity and security of filter integrity test data must not be seen only as an IT problem but also as a potential global business risk. Low standards of data integrity and security may not only jeopardize the activities of the drug manufacturing company, but, even more critical, endanger the health of patients.

Data Integrity Statement | ALCOA+ Principles The Sartocheck® 5 Plus Filter Tester has been designed in accordance with the ALCOA principles as mentioned in the FDA “Data Integrity and Compliance with Drug CGMP Questions and Answers: Guidance for Industry” from December 2018 and the ALCOA+ principles as referred to in the MHRA “GXP’ Data Integrity Guidance and Definitions” from March 2018. Ask for our Data Integrity Statement for details. Data Security The Sartocheck® 5 Plus Filter Tester is a closed system and uses a custom Linux-based OS with Sartorius’ custom architecture to provide inherent...

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.

Intuitive iF-Design Rewarded Human Machine Interface (HMI) Straightforward menus, ergonomic design, formal language, user experience, and user-friendly control system all contributed to start processes within seconds and winning the iF Design Award 2018. Memory Management Even if the Sartocheck 5 Plus can hold more than 22,000 test results it will sooner or later be necessary to free memory space. The memory management gives the posibility to erase the memory in a secure manner, in compliance with 21CFR Part 11. 12.1” Touchscreen With a ± 88° Viewing Angle A large, bright screen with a great...

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.

Splashproof (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 Certified) The Sartocheck® 5 Plus is the only explosion-proof filter integrity tester device on the market. This allows safe testing and re-testing of alcohol-wetted filters according to recommended procedures (cf. PDA Technical Report 26 and Points To Consider part 2). The Sartocheck® 5 Plus is certified for explosion-prone areas Zone 2, Groupe II-B (IECEx, ATEX) | Class 1 Zone 2 Group II-B (FM – USA)....

Sartocheck® 5 and Sartocheck® 5 Plus Filter Testers The new Sartocheck® 5 Series comes in two variants to match the requirements of the customer with either model. Sartocheck® 5 The Sartocheck® 5 Filter Tester performs all standard integrity tests combined with the ultimate level of Data Integrity, intuitive Usability, and top-level Health and Safety Requirements. Should automation not be required, and if traditional QRM (data entry by bar code scanner, operator training …) is enough for regulatory compliance, the Sartocheck® 5 Filter Tester is sufficient. Sartocheck® 5 Plus The enhanced features...

Sartocheck® 5 Order code Usability All commonly used integrity test methods High quality 12.1’’ screen iF-design rewarded user interface LDAP Full data transfer in JSON and PDF Automation Remote administration Memory management Health, Safety and Environment Ingress protection IP64 Ex-proof (ATEX | IECEx | FM certified) Resistant to all current cleaning agents H2O2-vapor resistant (VHP) Automated cleaning of all pneumatics with up to 0.5 M NaOH (requires optional cleaning kit available in Q3 2021) Optional Accessory Kit for External Venting (backflow protection) Quality Risk Management Traditional...