Lyo Stoppers
High-elasticity halobutyl rubber stoppers engineered for lyophilization—excellent low-temperature resilience (-80°C), ultra-low outgassing, and superior sealing to protect sensitive biologics like vaccines and monoclonal antibodies.
Designed specifically for the demanding requirements of lyophilized injectables, our freeze-dry stoppers deliver unmatched performance across four critical dimensions: lyophilization compatibility, long-term sealing integrity, biological safety, and clinical & manufacturing efficiency.
Lyophilization Process Compatibility:
Formulated with high-elasticity halobutyl rubber, the stoppers withstand extreme cryogenic conditions from –80°C to –50°C without embrittlement or hardening. They exhibit minimal outgassing under high vacuum (≤1 Pa), preventing contamination of sensitive biologics. With a shrinkage rate ≤1.5%, they maintain perfect fit with borosilicate glass or PET vials throughout freeze-drying. Rapid rewarming (–50°C to 25°C) causes no stress cracking, and post-thaw rebound exceeds 92%. Surface polishing or fluoropolymer coating ensures particle shedding ≤1 particle/unit. High dimensional precision (tolerance ≤0.03 mm) enables seamless integration with automated half-press/full-press stoppering systems at speeds ≥300 vials/minute. Low moisture uptake prevents post-lyo humidity transfer to the drug cake.
Sealing & Protection:
After full compression, leakage rate is ≤0.01%, even under inversion or vibration. Oxygen permeability is ≤0.08 ml/(m²·24h·atm), and moisture transmission ≤0.1 g/(m²·24h), extending shelf life to 3–5 years. Compatible with N₂/Ar headspace filling, they provide dual protection for oxidation-prone drugs. Compression set ≤7% ensures stable sealing over time (25°C/60% RH). Post-puncture resealability supports multi-dose use. Stable from –20°C (cold chain) to 40°C (tropical storage), and enhanced by aluminum cap secondary sealing for microbial and particulate barrier.
Biological Safety:
Compliant with USP Class VI, EP, and ISO 10993-1—non-cytotoxic, non-sensitizing, non-irritating. Heavy metal migration ≤0.005 mg/dm²; phthalate-free. Protein/antibody adsorption ≤0.3%. Sterilized via EO or γ-ray (SAL = 10⁻⁶). No leachables or odor; pH shift ≤0.1 after reconstitution. Full traceability and alignment with FDA, NMPA, EMA, EU MDR, and ICH Q9.
Clinical & Production Efficiency:
Available in 2–50 mL sizes. Puncture force: 18–28 N. Color-coded options (e.g., purple, green) reduce medication errors. Tear strength ≥18 MPa; breakage rate ≤0.03%. 20% lighter than conventional stoppers—boosting warehouse density by 15%. Custom features like alignment rings and vent grooves optimize automated filling and prevent bubble formation.
| Category | Specification / Feature |
|---|---|
| Base Material | High-elasticity halobutyl rubber |
| Low-Temperature Resistance | Stable from –80°C to –50°C; no cracking or hardening |
| Vacuum Compatibility | ≤1 Pa; no outgassing or volatile release |
| Shrinkage Rate (Lyophilization) | ≤1.5% |
| Rebound After Rewarming | ≥92% (from –50°C to 25°C) |
| Freeze-Dry Cycle Endurance | ≥3 cycles (select grades) |
| Particle Shedding | ≤1 particle per stopper |
| Dimensional Tolerance | ≤0.03 mm |
| Moisture Uptake | Low; prevents drug cake hydration |
| Leakage Rate (Post-Compression) | ≤0.01% |
| Oxygen Permeability | ≤0.08 ml/(m²·24h·atm) |
| Water Vapor Transmission | ≤0.1 g/(m²·24h) |
| Inert Gas Compatibility | Yes (N₂, Ar) |
| Compression Set | ≤7% |
| Post-Puncture Resealability | Maintains seal integrity |
| Temperature Stability Range | –20°C to 40°C (no seal degradation) |
| Secondary Sealing | Compatible with aluminum/plastic caps |
| Biocompatibility Standards | USP Class VI, EP, ISO 10993-1 |
| Heavy Metal Migration | ≤0.005 mg/dm² |
| Plasticizers | None (phthalate-free) |
| Protein Adsorption | ≤0.3% |
| Sterilization Method | EO or γ-ray |
| Sterility Assurance Level (SAL) | 10⁻⁶ |
| pH Stability (Post-Recon.) | ΔpH ≤ 0.1 |
| Regulatory Compliance | NMPA, FDA, EMA, EU MDR, ICH Q9 |
| Size Range | 2 mL, 5 mL, 10 mL, 20 mL, 50 mL |
| Puncture Force | 18–28 N |
| Automation Throughput | ≥300 vials/minute |
| Color Options | Customizable (e.g., purple, green) |
| Tear Strength | ≥18 MPa |
| Breakage Rate (Logistics) | ≤0.03% |
| Weight Reduction | ~20% vs. standard; +15% warehouse density |
| Custom Features | Alignment ring, vent groove, polished/coated surface |