AELAB Sterile Test Kits for Reliable Pharmaceutical Quality Control

The AELAB Sterile Test Kits are meticulously engineered through over 50 strict inspection processes to ensure accuracy and safety in sterility testing. Manufactured under ISO9001 quality standards, each kit undergoes 100% completeness examination to guarantee reliability and traceability. With 34 specialized models tailored to different sample types and packaging formats, these kits are the trusted choice for pharmaceutical          sterility inspection.

🔬 How It Works?

The sterile test kits employ a membrane filtration method, where test articles pass through a microporous filter (0.22μm or 0.45μm) that captures microorganisms. Depending on the sample type—ampoule, vial, LVP, pre-filled syringe, or emulsion—the kit uses specialized adapters, tubing, and membranes to ensure complete, contamination-free filtration and accurate sterility results.

💡 Advantages

• ISO9001-certified manufacturing with full traceability
• Leakproof ultrasonic welding for maximum reliability
• Low EO residuals ensuring product safety
• Strong chemical and mechanical resistance in pump tubing
• Wide variety of models tailored to different pharmaceutical packaging types
• Transparent blister packs for easy handling and sterility assurance

🔍 Recommended Models by Use Case

• LVP in Bottle or Soft Pouch: PY220, KSF220, SDY220 series
• Liquid in Ampoule: APY220 / KAPY220 (antibiotics/non-antibiotics)
• Powder in Vial: DGB220 / KDGB220 for dissolution and filtration
• Insoluble Powder in Vial: NKF220 series with three-needle adapter
• Pre-Filled Syringe: PFS2 / PFS2D for closed-system transfer
• Viscous Liquids & Biological Products: CN220, DCN220 series
• Medical Instruments with Catheter: YLQ220 series
• Small Volume Parenteral (<5mL): DGB203 / KDGB203D

🧪 Ideal For

• Pharmaceutical sterility testing labs
• Biotechnology and biological product QC
• Injectable formulation analysis (ampoules, vials, pre-filled syringes)
• Medical device sterility validation (catheters, infusion sets, dialysis tubing)
• Regulatory compliance testing under GMP standards

Performance:

• Specialized ethylene oxide sterilization
• Transparent blister box packaging, compliance with international standards
• Ultrasonic welding process, smooth and secure weld, optimal leak proofness
• High FL flexible pump tube made by special composite, durable tension, wear- and pressure-resistant, filtration of maximum test articles completed smoothly
• Medical dialysis packaging imported from US adopted, sterility of products ensured, quick decomposing of ethylene oxide, less ethylene oxide residual
• Membrane pore size：0.45μm,0.22μm (Can be customized)