USP 87 Cytotoxicity Testing
Ensure the initial biological safety of your polymeric materials with high-sensitivity in vitro screening. Our USP <87> testing provides rapid, reliable detection of cytotoxic potential in plastics and elastomers.
USP <87> Cytotoxicity testing is a fundamental requirement for the biological evaluation of medical devices and pharmaceutical packaging. By exposing standardized mammalian cell cultures to material extracts, we can identify potential biological hazards early in the development process. This test is highly sensitive; any substance that negatively impacts cell health—whether from the raw material, additives, or manufacturing residues—will be detected.
The Objective of the USP Study
The primary aim is to determine if the test item possesses cytotoxic properties. At EBI, we utilize the L929 mouse fibroblast cell line, an industry standard, to observe how your material interacts with living cells.
This test is particularly critical for:
- Plastic & Elastomer Manufacturers: Verifying the safety of raw materials.
- Biotechnology Companies: Ensuring materials do not leach substances that could inhibit cell growth and reduce production yields.
- Regulatory Submissions: Providing necessary data for USP Class I-VI certification.
Methodology: The MEM Elution Assay
EBI follows a precise, standardized protocol to ensure reproducible and accurate results:
- Extraction: The device or material is immersed in Minimum Essential Medium (MEM), supplemented with 10% Fetal Bovine Serum.
- Standard Exposure: 24 hours at 37°C.
- Prolonged/Permanent Exposure: 72 hours at 37°C to simulate long-term patient contact.
- Cell Exposure: The resulting extract is applied at 100% concentration to a sub-confluent layer of L929 cells in multiple replicates.
- Incubation & Observation: Cells are incubated and monitored at specific intervals. After 48 hours, at least two trained experts independently examine the cells using high-grade light microscopy.
Evaluation and Grading
Cell health is visually quantified based on morphological changes, lysis, and growth inhibition. We use a standardized numerical scale from 0 to 4:
| Grade | Reactivity | Observation |
|---|---|---|
| 0 | None | Discrete intracytoplasmic granules; no cell lysis. |
| 1 | Slight | Not more than 20% of the cells are round, loosely attached, and without intracytoplasmic granules. |
| 2 | Mild | Not more than 50% of the cells are round and devoid of intracytoplasmic granules. |
| 3 | Moderate | Not more than 70% of the cell layers contain rounded cells and/or are lysed. |
| 4 | Severe | Nearly complete destruction of the cell layers. |
Pass/Fail Criteria: The material is considered non-cytotoxic if it achieves a Grade of 2 (Mild Reactivity) or lower. A Grade 3 or higher is considered a cytotoxic effect.
Sample Requirements & Logistics
To ensure no delays in your testing, please provide samples based on the following guidelines:
- Standard USP Requirements:
- Thickness < 0.5 mm: 60 cm²
- Thickness ≥ 0.5 mm: 30 cm²
- Irregular (high density): 2 grams
- Irregular (low density): 1 gram
- Liquid: 10 ml
- MHLW (Japan) Requirements: 8 grams or 120 cm² / 240 cm² (depending on test plan).
- Turnaround Time: Standard completion in 4 weeks.
Standards & Compliance
EBI conducts USP <87> testing in strict accordance with:
- USP General Chapter <87>: Biological Reactivity Tests, In Vitro.
- ISO 17025: Accredited laboratory standards ensuring data integrity.
- MHLW Standards: Supporting submissions for the Japanese market.
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
Is USP <87> the same as ISO 10993-5?
They are very similar, as both test for cytotoxicity. However, USP <87> is specifically designed for the pharmaceutical and biotech industries (plastics and elastomers), while ISO 10993-5 is the global standard for all medical devices. EBI can perform both to suit your target market.
What happens if my material fails (Grade 3 or 4)?
A failure indicates that a substance is leaching from your material at toxic levels. We can assist with a root-cause analysis, investigating potential culprits such as processing oils, mold release agents, or the polymer composition itself.
Why use the L929 cell line?
L929 cells are used because they are sensitive, stable, and have a long history of use in biocompatibility testing, allowing for easy comparison of results across the industry.
Is USP the same as ISO 10993-5?
They are very similar, as both test for cytotoxicity. However, USP <87> is specifically designed for the pharmaceutical and biotech industries (plastics and elastomers), while ISO 10993-5 is the global standard for all medical devices. EBI can perform both to suit your target market.
What happens if my material fails (Grade 3 or 4)?
A failure indicates that a substance is leaching from your material at toxic levels. We can assist with a root-cause analysis, investigating potential culprits such as processing oils, mold release agents, or the polymer composition itself.
Why use the L929 cell line?
L929 cells are used because they are sensitive, stable, and have a long history of use in biocompatibility testing, allowing for easy comparison of results across the industry.
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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