Flash-Spun material · Sterile barrier systems
Sterile medical packaging
HDPE Flash-Spun material for sterile barrier systems (SBS), designed to meet ISO 11607-1, as declared by the manufacturer.
The Dawnsens® M series is designed for medical sterilisation packaging: 100% HDPE made by the Flash-Spun process, with a dense three-dimensional structure that combines microbial barrier, physical strength and air permeability. According to the manufacturer, it is designed to meet the requirements of sterile barrier systems (SBS) throughout their life cycle.
Dawnsens® M7001
Standard reference for sterile medical packaging: pouches, form-fill-seal (FFS) systems, rolls, trays and lids. According to the manufacturer, it is the right choice for most medical devices.
Dawnsens® M8001
Grade for pharmaceutical applications and irregularly shaped products that require greater strength, cleanliness and protection.
Packaging formats
Medical device packaging
- Chevron pouches
- Header bags
- Blisters and trays
- Rolls for FFS
Pharmaceutical packaging
- Steam sterilisation bags
- Lids and inserts for prefilled syringes
Hospital packaging
- Rolls for the central sterile services department
- Sterilisation bags
Biopharmaceutical packaging
- Flexible covers
Compatible with the main sterilisation methods, according to the manufacturer
Ethylene oxide (EtO)GammaElectron beamH₂O₂ plasmaSteam (121 °C)
Certifications
| Certification | Scope | Reference |
|---|---|---|
| ISO 11607-1 | Sterile barrier systems: microbial barrier, compatibility with forming, sealing and sterilisation, and shelf life | Compliance declared by the manufacturer |
| FDA 21 CFR 177.1520 | Food contact: olefin polymers | SGS SHAHG1820720001 |
| OEKO-TEX® Standard 100, Class I | Safety in contact with skin | Cert. 21.HCN.87997 |
| REACH SVHC | Substances of very high concern | SGS GZHL2204107109SD |
| DIN CERTCO | Recyclability of the M series (medical packaging) | Cert. P3R0011 |
| (EU) No 10/2011 | Plastic materials and articles in contact with food | Manufacturer’s declaration |
Applications by product type
Prefilled syringes
Challenge: condensation and insufficient gas exchange during steam sterilisation in an autoclave.
Solution: air permeability and hydrostatic resistance that support an even steam flow and fast drying.
IV catheters and safety needles
Challenge: risk of metal tips accidentally puncturing the sterile pack during transport.
Solution: the M8001 grade offers high resistance to puncture and tearing.
Wraps and surgical instruments
Challenge: lint and microparticle shedding when the pack is opened in the operating theatre.
Solution: continuous HDPE fibres with very low particle shedding when the pack is opened.
Anaesthesia kits and complex shapes
Challenge: packaging compatibility with low-temperature plasma sterilisation.
Solution: chemically inert HDPE mono-material, compatible with H₂O₂ plasma sterilisation.
Supply and manufacturing
Manufacturer The first Chinese manufacturer of Flash-Spun HDPE on a commercial scale, according to its corporate documentation, with its own intellectual property and a plant in Xiamen.
Recyclability HDPE mono-material with DIN CERTCO recyclability certificate (M series).
Clean-room manufacturing Production in a class 100,000 clean room, according to the manufacturer.
Sources: official Dawnsens® brochures “Medical Packaging Material” and “Corporation Introduction”; certificates with the reference shown in the table.