Blood Collection Stoppers
Medical-grade halobutyl rubber stoppers for blood collection tubes—USP Class VI, EP, and ISO 10993-4 compliant, non-hemolytic (≤0.5%), ensuring sample purity and analytical accuracy across clinical and diagnostic applications.
Engineered specifically for high-integrity blood sample handling, our blood collection tube stoppers deliver exceptional performance across four critical domains: biological safety, seal integrity, phlebotomy compatibility, and sample stability.
Biological Safety – Protecting Sample Purity:
Made from medical-grade halobutyl or butyl rubber, the stoppers comply with USP Class VI, European Pharmacopoeia, and ISO 10993-4 standards—ensuring no cytotoxicity and minimal hemolysis (≤0.5%). Heavy metal migration (Pb, Hg, Cd) is strictly controlled to ≤0.003 mg/dm², preventing interference in biochemical and immunoassays. Free from phthalates and residual solvents, they maintain red blood cell viability ≥98%. The material exhibits excellent blood compatibility—no interaction with erythrocytes, leukocytes, or platelets, and no activation of coagulation pathways. Sterilized via EO or γ-ray to SAL 10⁻⁶, they are ready for immediate aseptic use. With ≤0.2% adsorption of enzymes, antibodies, or hormones, they prevent false-negative/positive results. No leachables or odor; pH shift ≤0.05 and electrolyte deviation (Na⁺/K⁺) ≤2%. Full material traceability supports NMPA, FDA, and global regulatory compliance.
Seal Integrity – Long-Term Contamination Barrier:
High elasticity ensures compression set ≤6%, achieving 99.98% leak-proof sealing—even under inversion or vigorous shaking. Oxygen permeability ≤0.06 ml/(m²·24h·atm) limits blood oxidation (SpO₂ change ≤3%/24h). Moisture transmission ≤0.08 g/(m²·24h) prevents sample dilution or concentration. The smooth, non-porous surface limits microbial adhesion to ≤0.5 CFU/unit—ideal for blood bank storage. Compatible with nitrogen flushing for anaerobic samples. Stable from –20°C (frozen plasma) to 40°C (tropical transport). Dual-seal design with plastic/aluminum caps blocks dust and contaminants. Under refrigerated storage (2–8°C), annual seal degradation is ≤1%.
Phlebotomy & Operational Efficiency:
Optimal puncture force (15–25 N) enables easy needle penetration (21G–25G), reducing clinician fatigue. Anti-shedding design limits particle generation to ≤0.5 particle/puncture—protecting analyzers from clogging. Instant resealing after needle withdrawal prevents leakage during multi-tube draws. Non-slip surface texture enhances grip in emergency or mobile settings (e.g., ambulances). High dimensional precision (tolerance ≤0.02 mm) supports automated lines at ≥500 tubes/minute. Vacuum-compatible (stable at ≤5 kPa) for seamless blood draw. Color-coded options (red, purple, green) align with anticoagulant/serum separator types to reduce labeling errors.
Sample Stability – Preserving Diagnostic Value:
Fully compatible with EDTA-K₂, sodium heparin, and sodium citrate—coagulation time deviation ≤5%. No interference with clot activators (e.g., thrombin, silica); serum separation time variation ≤10%. Withstands –80°C freezing without cracking. No assay-interfering leachables—analytical bias ≤3% for glucose, lipids, antigens, and antibodies. Extends whole blood shelf life to 35 days when used with CPDA-1. Minimal blood residue on needle withdrawal reduces waste in pediatric sampling. Passes vibration testing (5–50 Hz), ensuring seal integrity during inter-lab transport.
| Category | Specification / Feature |
|---|---|
| Base Material | Medical-grade halobutyl / butyl rubber |
| Standards Compliance | USP Class VI, EP, ISO 10993-4 |
| Hemolysis Rate | ≤0.5% |
| Heavy Metal Migration | ≤0.003 mg/dm² (Pb, Hg, Cd) |
| Plasticizers / Solvents | None (phthalate-free, solvent-free) |
| Red Blood Cell Viability | ≥98% |
| Blood Compatibility | No coagulation activation; compatible with whole blood, serum, plasma |
| Sterilization Method | EO or γ-ray |
| Sterility Assurance Level (SAL) | 10⁻⁶ |
| Adsorption of Biomarkers | ≤0.2% (enzymes, antibodies, hormones) |
| pH Stability (Post-Contact) | ΔpH ≤ 0.05 |
| Electrolyte Deviation (Na⁺/K⁺) | ≤2% |
| Traceability | Full batch traceability; CoA provided; NMPA/FDA compliant |
| Compression Set | ≤6% |
| Leakage Rate | ≤0.02% (seal pass rate ≥99.98%) |
| Oxygen Permeability | ≤0.06 ml/(m²·24h·atm) |
| Water Vapor Transmission | ≤0.08 g/(m²·24h) |
| Microbial Adhesion | ≤0.5 CFU per stopper |
| Inert Gas Compatibility | Yes (N₂ for anaerobic samples) |
| Temperature Range | –20°C to 40°C (stable after cycling) |
| Annual Seal Degradation (2–8°C) | ≤1% |
| Puncture Force | 15–25 N |
| Particle Shedding | ≤0.5 particle per puncture |
| Resealability | Immediate self-sealing after needle withdrawal |
| Surface Texture | Non-slip grip pattern |
| Dimensional Tolerance | ≤0.02 mm |
| Automation Throughput | ≥500 tubes/minute |
| Vacuum Compatibility | Stable at ≤5 kPa |
| Color Options | Customizable (e.g., red = serum, purple = EDTA, green = heparin) |
| Anticoagulant Compatibility | EDTA-K₂, sodium heparin, sodium citrate |
| Clot Activator Compatibility | Thrombin, silica, glass particles |
| Freeze Resistance | Stable at –80°C; no cracking |
| Analytical Interference | ≤3% bias on key assays (glucose, lipids, immunoassays) |
| Blood Storage Extension | Up to 35 days with CPDA-1 |
| Vibration Resistance | Passes 5–50 Hz transport simulation |