HDPE/LLDPE materials can withstand certain sterilization methods, subject to strict limitations:
Ethylene Oxide (EO): The most commonly used method; 100% compatible, but requires rigorous aeration (residual levels ≤ 1 ppm);
Gamma Irradiation: Feasible at doses ≤ 25 kGy, but may lead to material yellowing and embrittlement (requiring the addition of anti-radiation agents);
Steam Sterilization (121°C): Not recommended! The melting point of HDPE is only 130°C, resulting in severe deformation at high temperatures;
Dry Heat Sterilization: Also not feasible (softening occurs at temperatures > 100°C).
Applicable Scenarios:
Non-sterile Preparations (e.g., standard tablets): Sterilization is not required; the bottles simply undergo cleaning in a cleanroom environment followed by ozone disinfection;
Sterile API Intermediates: Utilize EO-sterilized bottles, with filling conducted within a Grade A cleanroom environment;
Medical Device Accessories (e.g., reagent bottles): Gamma irradiation sterilization is an option (provided that material stability is duly validated).