Sterile Filtration and Single-Use System Validations

Sterile Filter and Single-Use System Validations

Complete Your Process Validation With Confidence® 

Validation by Sartorius ensures reliable production processes that comply with legal requirements. Confidence® Validation Services provide comprehensive understanding of filters and single-use systems used in your process to make the best decisions in terms of budget, timeframe, and regulatory acceptance. 

Sartorius Bacterial Challenge Test 

Learn how you can profit from the Sartorius approach to validating sterilizing-grade filters: 

  • Selecting the right test filter and approach considering product limitations and process constraints 
  • Best-in-class simulation of actual process conditions 
  • More than 25 years of experience to meet every need 

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Our Services at a Glance

Thanks to our scalability, we guarantee full process relevance using identical materials and formats, adapted to a favorable test product volume in these validation studies:

For Filters 

  • Bacterial challenge test (BCT), viability test (VT), and test bacteria selection 
  • Chemical compatibility test 
  • Product-specific integrity test 
  • Particle release test
  • Adsorption studies 
  • Extractables and leachables validation services

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For Single-Use Systems

  • Chemical compatibility test 
  • Integrity and microbial ingress test 
  • Shipping test 
  • Pharmacopeia test 
  • Validation studies for specific process applications  
    (biowelding, biosealing, freeze and thaw) 
  • Extractables and leachables validation services

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Microbiological and Physico-Chemical Studies for Filters

Bacterial Challenge and Viability Testing 

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. 

Chemical Compatibility Testing

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).

Product-Specific Integrity Test

Confidence®  supports integrity testing by standardly 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.

Particle Release Testing

At Sartorius, we quantify particles that could be released under the most unfavorable process conditions from filters that you use as product liquid.

Adsorption Study

The binding of product components to filter membranes can adversely affect product efficacy. To determine critical factors that influence the binding process (e.g., temperature or pH value), we use appropriately sensitive analytical test methods. 

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Confidence® provides comprehensive validation for our sterile filters, prefilters and more. Our services complement Sartorius filters perfectly for use in your process. Regardless of the respective process step or medical product.

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Physical and Microbiological Validation Scope for Single-Use Systems

Integrity and Microbial Ingress Testing

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

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. 

Shipping Test

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.

Pharmacopeia Testing

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 3.1 chapters “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.”

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Our validation services cover the whole Sartorius portfolio of single-use systems, from Celsius® & Flexsafe® bags up to OPTA® connectors. Confidence® complements all SUS in any customer application for freezing & thawing, storage, shipping or mixing.

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Three Basic Principles of Process Validation

  1. ​Organized & Documented Common Sense​
    Be systematic in theoretical approaches to validation
  2. Plan According to Scientific and Risk-Based Regulations 
    ​Plan includes the validation experiments, the analysis and the documentation of the validation data​
  3. Act According to the Plan
    ​Process validation must be  done by individuals with the necessary training and experience​

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