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Knowledge About Chinese Medical Bottle Caps
Author:
Munan Glass
Date:
2025-11-07
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Medical bottle caps are precision-engineered components that seal China’s injectable, oral and diagnostic containers.
These closures are governed by YBB, ChP and ISO rules, so every medical bottle cap is documented for traceability and double-checked for conformity.
Material Families
1. Pharma-grade PP/HDPE
Medical bottle caps molded from virgin polypropylene or high-density polyethylene remain dimensionally stable after 121 °C steam sterilisation. PP grades meet YBB 00112004, deliver a 0.2 g/10 min MFR and show ≥ 25 kJ m⁻² impact strength at 23 °C.
2. Aluminium shells (8011-H16)
Cold-rolled aluminium coil 0.22 mm thick is punched, deep-drawn and coated to create one-piece or flip-off medical bottle caps. The metal offers 125 MPa tensile strength, > 35 % elongation and zero corrosion after 24 h salt-spray, satisfying YBB 00152004.
3. Alu-plastic composites
An outer 0.25 mm Al skirt is crimped over an inner PP disc, giving medical bottle caps both tamper evidence and resealability. This hybrid cuts aluminium use by 30 % yet still passes 0.6 bar seal integrity and 1.2 m drop tests.
Appearance & Dimensional Code
Colours: standard RAL 9002 white, RAL 5010 gentian blue or custom Pantone matching; ΔE ≤ 1.0 versus master.
Surface: glossy, matte or soft-touch; Ra ≤ 0.4 µm, free from flash, sink or black spots.
Sizes: 13 mm, 20 mm, 28 mm, 32 mm and 36 mm neck finishes; thread pitch 1.7 mm, ovality ≤ 0.1 mm, diameter tolerance ± 0.08 mm.
Physical Performance Benchmarks
Seal: ≤ 0.05 mL water loss at 40 °C, 75 % RH, 28 days.
Torque: 0.8–1.2 N·m application, 0.3–0.6 N·m removal, child-resistant (CRC) variants 1.4 N·m first rotation.
Thermal: –40 °C 24 h ⇄ +60 °C 24 h, five cycles, zero cracking.
Drop: 1.5 m on concrete, six faces, no loosening or fragmentation.
Chemical & Biological Compliance
Extractables: ≤ 0.5 µg cm⁻² for Zn, Pb, Cd each; UV absorbance ≤ 0.08 at 220–240 nm (YBB 00142004).
pH shift: ≤ 1.0 after 70 °C water 24 h.
Cytotoxicity: ISO 10993-5 Grade 0; haemolysis < 5 %.
Bioburden: 10 CFU g⁻¹ max; sterile SAL 10⁻⁶ available via gamma 25 kGy.
Functional Upgrades
Child-resistant & senior-friendly: two-step push-down-and-turn or squeeze-grip medical bottle caps open with < 15 N yet defeat > 85 % children under five (ISO 8317).
Tamper evidence: bridge-break ring or flip-off button gives visible first-opening signal.
Freeze-dry vents: 0.22 µm PTFE membrane lets vapour exit while maintaining sterility.
RFID inside: 13.56 MHz tag sealed in PP cavity for unit-level authentication and cold-chain tracking.
In short, China produces medical bottle caps in plastic, aluminium and composite architectures, each calibrated to millimetre tolerances, rigorous chemical thresholds and multifunctional add-ons. By aligning with YBB, ISO and FDA modules, these medical bottle caps secure dosage purity, simplify regulatory filings and support global pharma distribution lines.
TAG:
Glass Vial,Pharmaceutical glass bottles
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