T/CNPPA 2003-2017 Oral solid pharmaceutical high-density polyethylene nonwoven bag iron-based oxygen absorber

Scope

This standard specifies the technical specifications and requirements, test methods, inspection rules, judgment rules, and requirements for product packaging, labeling, transportation, and storage of iron-based oxygen absorbers packaged in high-density polyethylene nonwoven bags for oral solid dosage forms (referred to as "bagged iron-based oxygen absorbers"). The high-density polyethylene nonwoven bags for iron-based oxygen absorbers specified in this standard are composed of iron-based oxygen absorbers and high-density polyethylene nonwoven fabrics, and are suitable for oral solid dosage forms. Iron-based oxygen absorbers refer to products primarily made from iron powder, which can react with oxygen and reduce the oxygen concentration in the packaging of oral solid dosage forms within a specified timeframe and maintain this reduction for a certain period. High-density polyethylene nonwoven fabrics are made from high-density polyethylene as the main raw material using nonwoven production processes. They have a multi-layered continuous physical structure and balanced physical properties. Anti-static agents and fluorescent whitening agents are not allowed. Depending on the specific needs, it is necessary to study and evaluate the physicochemical properties of high-density polyethylene nonwoven fabrics, the material specifications (mass per unit area), material cleanliness, particulate contamination, shedding levels, and waterproof and breathable performance.

Development Information

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