Sartorius Stedim Biotech Sartocheck 5 Plus filter integrity tester

Sartorius Stedim Biotech’s Sartocheck 5 Plus filter integrity tester is designed for use in downstream processing in the pharmaceutical industry. Based on users’ needs to confirm the integrity of filters in pharmaceutical production, the product features functions for ensuring maximum data integrity and compliance with future requirements of quality risk management.

The tester is designed to improve the detectability of operator errors, improper test set-ups and out-of-tolerance environmental conditions. It is also easier to use than the company’s previous models, meaning false passed and false failed test results should be relegated to the past.

Where other devices are limited in their flow measurement capability, the filter tester has been designed to cover the complete range of integrity testing from small syringe filters up to large multi-round housings and crossflow cassettes, with diffusion rates of up to thousands of millilitres per minute. In addition, the automatic test time feature for diffusion and water intrusion, along with accelerated bubble point testing, reduces overall test time. Parallel bubble point testing also saves time, enabling up to 10 small filters to be checked with the device.

User benefits include a large (12″), bright screen, an ergonomic interface, an easy-to-clean design, data integrity and inherent virus protection. The product is ATEX/IECEx/FM compliant, protecting operators by allowing safe integrity testing of alcohol-wetted filters. To prevent cross-contamination, the device can be used together with an accessory kit for external venting.

The product comes with comprehensive quality risk management documentation, including FMEA (Failure Mode and Effects Analysis). Qualification protocols are available and operational qualification can be performed by SSB’s Service team for peace of mind. The company also provides onsite annual or biannual calibration along with preventive maintenance.

Purchase of the device includes a pre-established roadmap of software upgrades that come with comprehensive risk assessments. Add-on features do not require requalification. Software upgrades include features for high data integrity, QRM, HSE and usability throughout the entire life cycle of the product.