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.

CategorySpecification / Feature
Base MaterialMedical-grade halobutyl / butyl rubber
Standards ComplianceUSP Class VI, EP, ISO 10993-4
Hemolysis Rate≤0.5%
Heavy Metal Migration≤0.003 mg/dm² (Pb, Hg, Cd)
Plasticizers / SolventsNone (phthalate-free, solvent-free)
Red Blood Cell Viability≥98%
Blood CompatibilityNo coagulation activation; compatible with whole blood, serum, plasma
Sterilization MethodEO 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%
TraceabilityFull 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 CompatibilityYes (N₂ for anaerobic samples)
Temperature Range–20°C to 40°C (stable after cycling)
Annual Seal Degradation (2–8°C)≤1%
Puncture Force15–25 N
Particle Shedding≤0.5 particle per puncture
ResealabilityImmediate self-sealing after needle withdrawal
Surface TextureNon-slip grip pattern
Dimensional Tolerance≤0.02 mm
Automation Throughput≥500 tubes/minute
Vacuum CompatibilityStable at ≤5 kPa
Color OptionsCustomizable (e.g., red = serum, purple = EDTA, green = heparin)
Anticoagulant CompatibilityEDTA-K₂, sodium heparin, sodium citrate
Clot Activator CompatibilityThrombin, silica, glass particles
Freeze ResistanceStable at –80°C; no cracking
Analytical Interference≤3% bias on key assays (glucose, lipids, immunoassays)
Blood Storage ExtensionUp to 35 days with CPDA-1
Vibration ResistancePasses 5–50 Hz transport simulation

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