Current Regulatory Status and Development Prospects of the Blow-Fill-Seal(BFS)Technology in the Pharmaceutical Industry
10.3870/j.issn.1004-0781.2025.07.012
- VernacularTitle:吹灌封技术在制药行业的监管现状及发展前景
- Author:
Xiaoxu HAN
1
;
Feifei JIA
1
;
Mengyu YANG
1
;
Xia ZHAO
1
Author Information
1. 中国食品药品检定研究院,北京 100050
- Publication Type:Journal Article
- Keywords:
Blow-Fill-Seal technology;
Sterile assurance;
Development process;
Development prospect;
Industry regulation
- From:
Herald of Medicine
2025;44(7):1079-1082
- CountryChina
- Language:Chinese
-
Abstract:
The Blow-Fill-Seal(BFS)technology is a highly automated aseptic manufacturing process that significantly reduces contamination risks by integrating container blowing,filling,and sealing operations.First,this article introduced the core technical features of BFS equipment and its advantages in aseptic production,followed by a comparative analysis of regulatory requirements for BFS technology across different jurisdictions.Finally,in light of pharmaceutical industry trends,it explored the future development prospects of BFS technology in intelligent manufacturing and high-barrier material applications,while examining its potential value in personalized medicine and specialized drug production.
