Standard No.:	T/ZJYBF 0004-2023
English Name:	Laminated film and pouches(PET/VMPET/PE) for oral solid preparation
Chinese Name:	口服固体制剂用聚酯/镀铝聚酯/聚乙烯复合膜、袋
Chinese Classification:	C40    Medical optical instrument and endoscope
Professional Classification:	T/    Social Organization Standard
Source Content Issued by:	Zhejiang Pharmaceutical and Food Packaging Medical Excipients Industry Association
Issued on:	2023-09-19
Implemented on:	2023-12-1
Status:	valid
Target Language:	English
File Format:	PDF

本文件规定了药品口服固体制剂用聚酯/镀铝聚酯/聚乙烯复合膜、袋的技术要求、试验方法、检验规则以及标志、包装、运输和贮藏的要求。
本文件适用于以聚酯、镀铝聚酯、聚乙烯为基材复合而成，厚度小于 0.25 mm，供颗粒剂、散剂、片剂、丸剂、胶囊剂等口服固体制剂直接接触使用的膜、袋。贴膏剂包装袋、滴眼液外阻隔袋、医疗器械用包装袋、化妆品包装面膜袋等可参照本文件执行。