T/ZJYBF 0004-2023 Oral solid dosage formulation with polyester/aluminum-coated polyester/polyethylene composite film/bag

Scope

Main Technical Content: Polyester/Aluminum-Coated Polyester/Polyethylene Composite Films and Bags for Oral Solid Dosage Forms **Scope of This Document**: This document specifies the technical requirements, testing methods, inspection rules, and requirements for marking, packaging, transportation, and storage of polyester/aluminum-coated polyester/polyethylene composite films and bags used in oral solid dosage forms of drugs. This document applies to films and bags made of polyester, aluminum-coated polyester, or polyethylene as substrates, with a thickness of less than 0.25 mm, intended for direct contact with granules, powders, tablets, pellets, capsules, and other oral solid dosage forms. Patch application bags, eye drop outer barrier bags, medical device packaging bags, and cosmetic packaging facial masks can refer to this document for implementation. **Normative Reference Documents**: The content of the following documents is an integral part of this document through normative reference. Among them, the referenced documents with a specified date only apply to the version corresponding to that date; the latest versions (including all amendment sheets) of the non-dated referenced documents apply to this document. - GB/T 191 *Packaging and Transportation Symbols and Markings* - GB/T 2828.1 *Counting Sampling Inspection Procedures - Part 1: Batch Sampling Plan for Acceptance Quality Limit (AQL)* - GB/T 4456 *Polyethylene Blow Molded Films for Packaging* - GB/T 6672 *Determination of Thickness of Plastic Films and Sheets - Mechanical Measurement Method* - GB 9685 *National Food Safety Standard - Standards for Additives Used in Food Contact Materials and Products* - GB/T 16958 *Biaxially Oriented Polyester Films for Packaging* - GB/T 21302 *General Requirements for Composite Films and Bags for Packaging* - BB/T 0030 *Packaging Aluminum-Coated Films* - *Chinese Pharmacopoeia* General Provisions 0861 *Determination of Residual Solvents* - *Chine

Development Information

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