USP Biological Reactivity Testing (Class I–VI)
Ensure the safety and performance of your polymeric materials. EBI provides comprehensive USP <87> and <88> testing to certify your plastics and elastomers for medical and biopharmaceutical use.
Biological reactivity tests are designed to determine the in vitro and in vivo response of elastomers, plastics, and other polymeric materials that come into direct or indirect contact with patients or bioprocess fluids. While USP Class VI is the industry’s most recognized benchmark, EBI’s experts provide a complete evaluation framework to mitigate risks and protect your yields.
The Importance of USP 87 and USP 88
Regulatory compliance and bioprocessing efficiency rely on two critical chapters of the U.S. Pharmacopeia:
- USP <87> (In Vitro): This chapter focuses on cytotoxicity testing with mammalian cells. It is a highly sensitive screen that detects potential reactivity which could decrease cell growth—a vital factor for biopharmaceutical companies looking to maximize profit per batch.
- USP <88> (In Vivo): This chapter classifies plastics into six classes (Class I–VI) based on their response in animal models. USP Class VI is the most rygorous, requiring Systemic Injection, Intracutaneous Reactivity, and Implantation testing.
USP Classification of Plastics
The required tests are determined by the intended body contact and duration. At EBI, we help you identify the correct class for your material based on the table below:
| Body Contact | Limited (<24h) | Prolonged (24h–30d) | Permanent (>30d) |
|---|---|---|---|
| Skin | Class I | Class I | Class I |
| Mucosal Membrane | Class I | Class III | Class V |
| External Communicating | Class III | Class V | Class VI |
| Implant Devices | Class V | Class VI | Class VI |
Our Testing Methodologies
EBI offers a full suite of USP biological reactivity assays to provide a complete safety profile of your materials.
1. In Vitro Reactivity (USP <87>)
- MEM Elution / Cytotoxicity: We expose mammalian cell cultures to material extracts to observe for signs of toxicity or growth inhibition. This is often the first indicator of material instability.
2. In Vivo Reactivity (USP <88>)
To achieve USP Class VI certification, materials and their extracts (in various vehicles like Saline, Alcohol, PEG, and Vegetable Oil) must pass three specific tests:
- Systemic Injection Test: Assessing for general toxicity and systemic response following intravenous or intraperitoneal injection.
- Intracutaneous Test: Evaluating the potential of the material extracts to cause local irritation.
- Implantation Test: Determining the local tissue response of the actual material when placed directly into muscle or subcutaneous tissue.
Why USP Class VI Alone May Not Be Enough
While many manufacturers request only a Certificate of Compliance (COC) for USP Class VI, EBI recommends a combined approach. Testing in accordance with both USP <87> and <88> provides a more robust data set. In the biotech industry, even a material that passes Class VI can still harbor low-level reactivity that reduces microbial or cell growth, significantly affecting your production yield.
Standards & Compliance
EBI’s testing protocols are strictly aligned with:
- USP General Chapter <87>: Biological Reactivity Tests, In Vitro.
- USP General Chapter <88>: Biological Reactivity Tests, In Vivo.
- ISO 17025: Ensuring all results are accurate and ready for regulatory submission.
How We Work
Discovery & Insight
We begin with an in-depth consultation to understand your needs, challenges, and objectives. This helps us define the right strategy and scientific approach for your project.
Design & Development
Our experts translate your vision into actionable plans — combining innovative research, data, and technology to build precise and reliable solutions.
Delivery & Support
We implement the solution with full transparency and ongoing communication. After delivery, we stay involved — supporting you with optimization, updates, and future improvements.
FAQ: Frequently Asked Questions
What is the difference between ISO 10993 and USP Class VI?
While both assess biocompatibility, ISO 10993 is a global standard for medical devices, whereas USP <88> is traditionally used for the classification of plastic materials and packaging components in the pharmaceutical and biotech industries.
Why are multiple extraction vehicles (oils/saline) used?
Different chemicals may leach into different fluids. By using polar (saline), semi-polar (alcohol/saline), and non-polar (oil) vehicles, we ensure that every potential leachable is accounted for in the safety assessment.
How many samples do I need for a full USP Class VI test?
Sample requirements vary based on the physical form of your plastic or elastomer. Contact our team with your material dimensions for a specific sampling plan.
What is the difference between ISO 10993 and USP Class VI?
While both assess biocompatibility, ISO 10993 is a global standard for medical devices, whereas USP <88> is traditionally used for the classification of plastic materials and packaging components in the pharmaceutical and biotech industries.
Why are multiple extraction vehicles (oils/saline) used?
Different chemicals may leach into different fluids. By using polar (saline), semi-polar (alcohol/saline), and non-polar (oil) vehicles, we ensure that every potential leachable is accounted for in the safety assessment.
How many samples do I need for a full USP Class VI test?
Sample requirements vary based on the physical form of your plastic or elastomer. Contact our team with your material dimensions for a specific sampling plan.
Contact with us
We’re open to collaboration and research partnerships. Fill out the form — our team will respond as soon as possible.
Location:
Europejski Instytut Biomedyczny sp. z o.o.
ul. Bartycka 63A lok. 6, 00-716 Warszawa
Mail:
contact@ebi.bio
Phone:
+48 22 780 06 32
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