Pyrogen Testing (PTS)/Endotoxin Testing Services for Pharmaceutical & Biotechnology Labs
Greenlink Laboratory offers comprehensive Compost Testing Services tailored for agricultural use and export compliance. Our advanced testing evaluates essential parameters such as nutrient content (NPK), organic matter, pH, moisture, C\:N ratio, pathogens, and heavy metals to ensure the compost meets national and international quality standards like FCO, ISO, and APEDA. These analyses help farmers improve soil fertility, ensure safe crop production, and enable exporters to meet regulatory requirements for organic certifications. With accurate, reliable results and expert guidance, Greenlink supports sustainable farming and global market access.
Why Endotoxin Testing is Essential?
Greenlink Laboratory offers precise endotoxin testing services to ensure the safety and efficacy of pharmaceutical products, medical devices, and biotechnology applications. Endotoxins, if present above limits, can cause severe adverse reactions in humans, making testing critical in regulatory compliance and patient safety.
What We Test For
- Endotoxins in injectable drugs, vaccines, and IV fluids
- Raw materials and excipients for endotoxin contamination
- Medical devices and implants
- Water and process fluids (WFI, purified water)
- Pharmaceutical production environment monitoring
Who Needs Endotoxin Testing?
- Pharmaceutical manufacturers
- Biotechnology research and production labs
- Medical device manufacturers
- Clinical and diagnostic laboratories
- Contract research organizations (CROs)
- Regulatory and quality control departments
Standards and Regulatory Compliance
- USP Pharmacopeia Endotoxin Limits and Testing
- European Pharmacopeia (EP) guidelines
- Japanese Pharmacopeia (JP)
- FDA and EMA regulations on endotoxin control
- ISO 17025 Accredited Laboratory
Benefits of Our Endotoxin Testing
- Accurate quantification of bacterial endotoxins in products and raw materials
- Compliance with pharmacopeial standards (USP, EP, JP)
- Ensures patient safety and product quality
- Rapid turnaround with validated testing methods
- Support for process validation and quality assurance
Why Choose Greenlink?
- State-of-the-art LAL (Limulus Amebocyte Lysate) testing technology
- Experienced microbiologists and quality assurance experts
- Strict adherence to global regulatory requirements
- Comprehensive reporting with certified results
- Customized testing packages to fit your requirements
Endotoxin Testing Methods and Parameters
| Test Method | Sample Type | Detection Limit | Purpose | Reference Standard |
|---|---|---|---|---|
| LAL Gel Clot | Injectables, water | 0.03 EU/mL | Qualitative endotoxin detection | USP, EP, JP |
| LAL Chromogenic | Pharmaceutical products | 0.001 EU/mL | Quantitative endotoxin measurement | USP, EP |
| LAL Turbidimetric | Medical devices, water | 0.01 EU/mL | Quantitative endotoxin assay | USP, FDA |
| Recombinant Factor C | Pharma, biotech samples | 0.005 EU/mL | Alternative endotoxin detection | ISO standards |