Sartoius Stedim Biotech (SSB) has launched its new Sartocheck 5 Plus filter integrity tester designed for use in downstream processing. Based on customers’ needs to confirm the integrity of filters in pharmaceutical production, Sartocheck 5 Plus features functions for ensuring maximum data integrity and compliance with future requirements of quality risk management, such as the upcoming Annex 1 of the European Medicines Agency (EMA).

The new filter tester is designed to improve the detectability of operator errors, improper test set-ups and out-of-tolerance environmental conditions. This advanced 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 milliliters 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 is also a significant time saver as this function enables up to 10 small filters to be checked with one Sartocheck 5 Plus.            

Sartocheck 5 Plus features a 12” screen, along with an ergonomic interface, an easy-to-clean design, improved data integrity and inherent virus protection. It’s also ATEX | IECEx | FM compliant. It protects 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 filter integrity tester comes with quality risk management documentation, including an FMEA (Failure Mode and Effects Analysis). Qualification protocols are available and operational qualification can be performed by SSB’s Service team. The company also provides on-site annual or biannual calibration along with preventive maintenance.

The device includes a pre-established roadmap of software upgrades that come with comprehensive risk assessments. Add-on features do not require re-qualification. The software upgrades include features for data integrity, QRM, HSE and usability, throughout the entire life cycle of the filter integrity tester.