“Empower your processes with confidence through our Sterile Filtration and Single-Use System Validations, ensuring unwavering process reliability on our service website.”
Complete Your Process Validation With Confidence®
Validation by Green Biotec ensures reliable production processes that comply with legal requirements. Confidence® Validation Services provide a comprehensive understanding of filters and single-use systems used in your method to make the best decisions regarding budget, timeframe, and regulatory acceptance.
Green Biotec Bacterial Challenge Test
Learn how you can profit from the Green Biotec approach to validating sterilizing-grade filters:
- Selecting the correct test filter and approach considering product limitations and process constraints.
- Best-in-class simulation of actual process conditions.
- More than 25 years of experience in meeting every need.
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Our Services at a Glance
We guarantee full process relevance using identical materials and formats adapted to a favourable 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.
[Go to Filter Validation]
For Single-Use Systems
- Chemical compatibility test.
- Integrity and microbial ingress test.
- Shipping test.
- Pharmacopeia test.
- Validation studies for specific process applications (welding, sealing, freeze and thaw).
- Extractables and leachables validation services.
- RNase Test.
[Go to Single-Use Systems Validation]
Microbiological and Physico-Chemical Studies for Filters
“Dive into our service expertise with Microbiological and Physico-Chemical Studies, ensuring the utmost precision and performance for filters on your journey to uncompromised quality.”
Product-Specific Integrity Test
Confidence® supports integrity testing by optionally using your product as wetting fluid. The product-specific integrity test specification is determined based on measurements recommended by regulatory bodies such as the FDA or EMA.
Particle Release Testing
We quantify particles that could be released from the filters used in the product solution.
Adsorption Study
The binding of product components to filter membranes can adversely affect product efficacy, so we perform sampling to be used for further analysis.
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: Brevundimonasdiminuta). 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).
[Consult our Validation Service Experts]
Physical and Microbiological Validation Scope for Single-Use Systems
“Explore the Robust Validation Scope for Single-Use Systems, Covering both Physical and Microbiological Aspects, Ensuring Unparalleled Quality Assurance in Bioprocessing.”
Shipping Test
We perform shipping tests by ASTM and ISTA standards to verify the integrity of Green Biotec bags and single-use systems used for shipping intermediate products. In compliance with regulatory requirements, our SUS are first subjected to accurate shipping or shipping simulations and then tested for mechanical resistance.
Pharmacopeia Testing
We perform chemical and biocompatibility tests for any components to check the quality of raw materials used. 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
RNase Test determines RNase activity in a bag sample by a qualified method using fluorometric assay/sample.
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. We offer physical and microbial tests for Green Biotec and non-Green Biotec disposable systems to verify integrity.
Chemical Compatibility Testing
Chemical compatibility testing is required if solutions are used that are not covered by Green Biotec validation guides or if process parameters are used outside of our recommendations (temperature, exposure time, etc.). Our experts determine the chemical compatibility status between Green Biotec disposable systems and customer solutions after storage by performing mechanical tests to assure process safety.
[Consult our Validation Service Experts]
Three Basic Principles of Process Validation
Kenneth Chapman, one of the most influential figures in Process Validation, defined these three principles in the late 1980s and argued that process validation is “organized, documented common sense.”
- Organized & Documented Common Sense
- Be systematic in theoretical approaches to validation.
- Plan According to Scientific and Risk-Based Regulations
- The plan includes the validation experiments, the analysis, and the documentation of the validation data.
- Act According to the Plan
- Individuals must do process validation with the necessary training and experience.
Related Products
Discover cutting-edge solutions that complement your processes and elevate your laboratory or bioprocessing capabilities.
- Sterile Filtration
- Liquid Storage & Shipping
- Frozen Storage & Shipping
- Sterile Filtration:
- Ensure the integrity of your processes with our advanced sterile filtration products, safeguarding your valuable samples and biopharmaceuticals.
- Liquid Storage & Shipping:
- Experience reliable and secure liquid storage and shipping solutions designed to maintain the integrity of your valuable materials throughout their journey.
- Frozen Storage & Shipping:
- Preserve the quality of your biopharmaceuticals with our state-of-the-art frozen storage and shipping options, ensuring stability and efficacy during transport and storage.