Reasons for choosing our testing services
ZHONGXI Testing has obtained inspection qualification certifications from multiple countries and regions worldwide. We possess a senior testing team and advanced testing methods, providing independent, impartial, and professional third-party verification services for global carbon projects.
Internationally recognized authority
Certified by multiple international standards such as CNAS, VCS, and GS, with reports universally applicable worldwide.
Global service capability
Covering 140+ countries and regions, it supports on-site detection and remote verification in multiple languages.
Professional experimental methods
Adopt standard experimental methods to ensure accurate and reliable data.
Before sending samples to our laboratory, most engineers ask whether we cover their specific material or application. The answer is often yes. Our bacterial Endotoxins testing services are designed to assess the Endotoxin contamination risk in a wide range of materials and products, helping clients ensure compliance with safety regulations and maintain product integrity. This service is particularly critical for industries such as pharmaceuticals, medical devices, food and beverage, and cosmetics, where Endotoxin contamination can have serious health and quality implications. Our testing capabilities are recognized by global regulatory bodies and are aligned with internationally accepted standards.
Testing Scope
Our bacterial Endotoxins testing services cover a diverse range of materials and products, including but not limited to:
- Pharmaceutical injectables and intravenous fluids
- Medical devices (e.g., catheters, implants, surgical instruments)
- Food and beverage products (e.g., dairy, fruit juices, preserved foods)
- Biological and diagnostic reagents
- Personal care and cosmetic products
- Water for medical and industrial use
The testing is applicable to various grades and forms of materials, such as liquids, solids, and lyophilized products. Application scenarios include preclinical evaluation, batch release testing, and regulatory compliance verification. Commonly referenced standards for our testing services include:
- ISO 10993-5: Biological evaluation of medical devices — Part 5: Tests for in vitro Cytotoxicity
- ASTM F1817: Standard Test Method for Bacterial Endotoxins Using the Gel-clot Technique
- EN 12100: European standard for Endotoxins testing in medical devices
- GB/T 16886.5: Biological evaluation of medical devices — Part 5: Tests for in vitro Cytotoxicity
Testing Items and Parameters
Our bacterial Endotoxins testing includes the following key items and parameters, each with specific graded limit requirements to ensure accurate and reliable results:
Test items typically include:
- Gel-clot technique for Endotoxin detection
- Limulus Amebocyte Lysate (LAL) assay
- Quantitative determination of Endotoxin units (EU) per unit of material
- Positive and negative controls
- Validation of test methods for specific matrices
Below is a table of typical parameters and graded limit requirements for Endotoxins in different materials:
| Material Type | Typical Parameter | Graded Limit (EU/mL or EU/g) |
|---|---|---|
| Pharmaceutical injectables | Endotoxin level | < 0.25 EU/mL |
| Medical devices | Endotoxin content | < 5 EU/g |
| Food and beverage | Endotoxin presence | Qualitative (pass/fail) |
| Biological reagents | Endotoxin activity | < 0.1 EU/mL |
Each test is conducted under controlled conditions to ensure reproducibility and accuracy, with results reported within the agreed timeline.
Data and Variation Analysis
In assessing parallel-sample and batch-to-batch variation, our laboratory employs rigorous statistical methods to ensure consistency and reliability. For parallel-sample testing, the relative deviation between duplicate or triplicate samples is calculated to determine the precision of the assay. Typically, the relative deviation is expected to be within ±15% for liquid samples and ±20% for solid samples, based on the U.S. Pharmacopeia (USP) guidelines.
Batch-to-batch variation is analyzed by comparing results from consecutive production batches or different lots of the same material. The acceptance window for batch-to-batch variation is typically set at a maximum of ±30% deviation from the established mean, provided that the individual sample results remain below the graded limit. This approach ensures that any significant shifts in Endotoxin levels are promptly identified and investigated.
Data is presented in a clear, standardized format, including raw data, calculated values, and statistical analysis. All variation assessments are documented in the final test report, providing clients with a comprehensive understanding of the material's Endotoxin profile and its consistency over time.
Clients are welcome to share drawings, material grades, or purchase specifications so that the testing plan can be matched precisely to their requirements. Our team is available to discuss specific needs and provide guidance on optimizing the testing process for their products.