Sterile Filter and Single-Use System Validations

Bacterial challenge testing is required by all regulatory authorities worldwide. A viability test carried out beforehand determines whether the test liquid influences the viability of the test organism (standard: Brevundimonas diminuta). Based on this, our experts select the optimal approach for your product solution. The Bacterial Challenge Test is performed under customer conditions to determine the ability to retain a minimum concentration of 10^7 bacteria per cm² of effective filter area. 

Confidence^® performs chemical compatibility tests of used filter material with your product formulation using worst-case process parameters. We employ our expertise to identify potential harmful effects and advise you on changes (if necessary).

Confidence^®  supports integrity testing by optionally using your product as wetting fluid. The product- specific integrity test specification is determined based on measurements as recommended by regulatory bodies such as the FDA or EMA.

We quantify particles that could be released from the filters used in the product solution.

The binding of product components to filter membranes can adversely affect product efficacy, so we perform sampling to be used for further analysis.

When a product is used outside of its qualified recommendations (e.g., temperature limits, material type, etc.), an integrity test should be performed to ensure the sterility of the stored solution. To verify integrity, we offer physical and microbial tests for Sartorius and non-Sartorius disposable systems.

Chemical compatibility testing is required if solutions are used that are not covered by Sartorius validation guides or if process parameters are used outside of our recommendations (temperature, exposure time, etc.). Our experts determine the chemical compatibility status between Sartorius disposable systems and customer solutions after storage by performing mechanical tests to assure process safety. 

We perform shipping tests in accordance with ASTM and ISTA standards to verify the integrity of Sartorius bags and single-use systems used for shipping intermediate products. In compliance with regulatory requirements, our SUS are first subjected to real shipping or shipping simulations and then tested for mechanical resistance.

To check the quality of raw materials used, we perform chemical and biocompatibility tests for any components. For the chemical tests, we follow the regulatory guidelines of USP <661> Container-Plastics and European Pharmacopeia chapter 3.1 “Materials used for the manufacture of containers”. For biocompatibility testing, we consider USP <87> “Biological reactivity tests, in vitro” and USP <88> “Biological reactivity tests, in vivo.”

RNase Test determines RNase activity in a bag sample by a qualified method using fluorometric assay/sample.