HDPE Non-woven Fabrics Iron Based Oxygen Absorbent Sachet for Oral Solid Preparation
2020/04/26 11:55:32
The HDPE non-woven fabricsiron based oxygen absorbent sachet stipulated in this standard is composed of ironbased oxygen absorbent and HDPE non-woven fabrics, which is suitable for oral solid preparation.
The ironbased oxygen absorbent refers to the absorbent which is made of iron powder as the main raw material, can react with the oxygen, and may reduce the concentration of oxygen in oral solid preparation packaging within the specified time and maintain for a period of time.
HDPE non-woven fabrics are made with HDPE as the main raw material via the non-woven production process. They have multilayer continuous physical structure and balanced physical properties. Antistatic agent and fluorescent whitening agent must not be used. According to different requirements, it is necessary to study and evaluate the physical and chemical properties of HDPE non-woven fabrics, material specifications (mass per unit area), material cleanliness, particulate contamination, floc falling level, waterproof permeability, particle barrier, tensile strength, tear resistance, rupture resistance and surface performance etc.
The HDPE non-woven fabrics materials specified in this standard include glue-coated materials and non-glue-coated materials, which shall not release substances sufficient to cause health risks (see GB/T 16886.1 for biological evaluation and test). Where the material is coated with glue, the continuity of the coating shall be assessed. The sachets usually shall be made via the electric heating sealing process for glue-coated materials, and shall be made via the ultrasonic sealing process for non-glue-coated materials.
HDPE non-woven fabrics ironbased oxygen absorbent sachet for oral solid preparation must be produced in the environment adaptive to the production environment of corresponding pharmaceutical.
Proper measures shall be taken to prevent the dust of iron powder and other raw materials from contaminating the outer surface of the HDPE non-woven fabrics iron based oxygen absorbent sachet for oral solid preparation in the production process.
The HDPE non-woven fabrics iron based oxygen absorbent sachet for oral solid preparation is placed in the packaging container of the oral solid preparation. While absorbing oxygen, the production preparation enterprise shall pay attention to the humidity in the packaging container, which should be kept at about 40%.