Guangdayuan’s PE Film Ensures Sterility for Medical Devices in Southeast Asia
author: Shenzhen Guangda Yuan Film Co., Ltd.
2025-07-29
Hospitals and clinics in Kuala Lumpur and Singapore demand sterile medical devices. Packaging films that shed particles or fail to resist sterilization can compromise sterility, leading to product recalls and reputational damage.
Guangdayuan’s medical-grade PE film is produced in a Class 100,000 cleanroom, with ≤30 particles/m² (≥0.5μm). The solvent-free coating passes ISO 11607 standards, compatible with EO and gamma sterilization. The 40μm thick version resists punctures from scalpel blades (tested to 1.5N force).
A medical device maker in Singapore reports 99.9% sterility rates after switching to our film, up from 98.5%. It meets ISO 13485 requirements and Thailand’s FDA standards. We provide batch-specific sterility test reports, with 7-day lead times for custom sizes—vital for time-sensitive medical supplies.#PE film#
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