Method for cleaning rubber closures for parenteral pharmaceutical preparations, involves intermixing or mixing raw rubber with other materials, cutting rubber sheets into piles, molding rubber piles and punching and trimming, and washing formed stopper with raw water and reverse osmosis water
	PATEL J B
	2024-01-13
专利权人	PATEL J B (PATE-Individual) ; PANDYA C R (PAND-Individual) ; PATEL S H (PATE-Individual) ; UNIVERSAL MEDICAP LTD (UVME-Non-standard)
申请日期	2024-01-13
专利号	IN202421002707-A
成果简介	NOVELTY - A method for cleaning rubber closures involves dispensing raw rubber and other materials, intermixing or mixing the raw rubber along with other materials, cutting rubber sheets into piles with defined weight after washing, conducting metal detection on the rubber piles, molding the rubber piles to form stopper and punching and trimming, where after completion of punching and trimming, the rubber stoppers are washed with raw water and reverse osmosis (RO) water and the rubber stoppers are treated with 20 g ozone generation for a duration of 10 minutes for ozonization. USE - Method for cleaning rubber closures for parenteral pharmaceutical preparations for stoppering drug vials (all claimed). ADVANTAGE - The method ensures high-quality closure hygiene, critical for parenteral pharmaceutical preparations. After ozonization, samples undergo a reducing substance test, with expected results falling within the range of 0.7-2 ml. The method enhances the cleanliness and safety of rubber closures in pharmaceutical applications. The method is capable of avoiding blooming of particles in rubber stopper, providing effective washing and cleaning procedures for pharmaceutical closures using ozone medium for possible reduction of impurities and extractable from finished product, and removing of any presence of contaminant or leachable in rubber closures.
IPC 分类号	A61K-008/19 ; A61L-002/04 ; B01D-061/02 ; C02F-001/44 ; C02F-001/78
国家	印度
专业领域	医药卫生
语种	英语
成果类型	专利
文献类型	科技成果
条目标识符	http://119.78.100.226:8889/handle/3KE4DYBR/18438
专题	中国科学院新疆生态与地理研究所
作者单位	1.PATEL J B (PATE-Individual) 2.PANDYA C R (PAND-Individual) 3.PATEL S H (PATE-Individual) 4.UNIVERSAL MEDICAP LTD (UVME-Non-standard)
推荐引用方式 GB/T 7714	PATEL J B. Method for cleaning rubber closures for parenteral pharmaceutical preparations, involves intermixing or mixing raw rubber with other materials, cutting rubber sheets into piles, molding rubber piles and punching and trimming, and washing formed stopper with raw water and reverse osmosis water. IN202421002707-A[P]. 2024.

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