World Library  
Flag as Inappropriate
Email this Article

Blow fill seal

Article Id: WHEBN0002246651
Reproduction Date:

Title: Blow fill seal  
Author: World Heritage Encyclopedia
Language: English
Subject: Food industry, Containers, Pharmaceutical industry, Orbital stretch wrapping, Boston round (bottle)
Collection: Containers, Food Industry, Pharmaceutical Industry
Publisher: World Heritage Encyclopedia
Publication
Date:
 

Blow fill seal

Blow-Fill-Seal (BFS) technology is a manufacturing technique used to produce small, (0.1mL) and large volume, (500mL +) liquid-filled containers. Originally developed in Europe in the 1930s, it was introduced in the United States in the 1960s, but over the last 20 years it has become more prevalent within the pharmaceutical industry and is now widely considered to be the superior form of aseptic processing by various medicine regulatory agencies including the U.S. Food and Drug Administration (FDA) in the packaging of pharmaceutical and healthcare products.

The basic concept of BFS is that a container is formed, filled, and sealed in a continuous process without human intervention, in a sterile enclosed area inside a machine. Thus this technology can be used to aseptically manufacture sterile pharmaceutical liquid dosage forms.

The process is multi-stepped: first, pharmaceutical-grade plastic resin is vertically heat extruded through a circular throat to form a hanging tube called the parison. This extruded tube is then enclosed within a two-part mould, and the tube is cut above the mould. The mould is transferred to the filling zone, or sterile filling space, where filling needles (mandrels) are lowered and used to inflate the plastic to form the container within the mould. Following the formation of the container, the mandrel is used to fill the container with liquid. Following filling the mandrels are retracted and a secondary top mould seals the container. All actions take place inside a sterile shrouded chamber inside the machine. The product is then discharged to a non-sterile area for labeling, packaging and distribution.

Blow-fill-seal technology reduces personnel intervention making it a more robust method for the aseptic preparation of sterile pharmaceuticals. BFS is used for the filling of vials for parenteral preparations and infusions, eye drops, and inhalation products. Generally the plastic containers are made up of polyethylene and polypropylene. Polypropylene is more commonly used to form containers which are further sterilised by autoclaving as polypropylene has greater thermostability.

See also

References

  • Soroka, W, "Fundamentals of Packaging Technology", IoPP, 2002, ISBN 1-930268-25-4
  • Yam, K. L., "Encyclopedia of Packaging Technology", John Wiley & Sons, 2009, ISBN 978-0-470-08704-6
This article was sourced from Creative Commons Attribution-ShareAlike License; additional terms may apply. World Heritage Encyclopedia content is assembled from numerous content providers, Open Access Publishing, and in compliance with The Fair Access to Science and Technology Research Act (FASTR), Wikimedia Foundation, Inc., Public Library of Science, The Encyclopedia of Life, Open Book Publishers (OBP), PubMed, U.S. National Library of Medicine, National Center for Biotechnology Information, U.S. National Library of Medicine, National Institutes of Health (NIH), U.S. Department of Health & Human Services, and USA.gov, which sources content from all federal, state, local, tribal, and territorial government publication portals (.gov, .mil, .edu). Funding for USA.gov and content contributors is made possible from the U.S. Congress, E-Government Act of 2002.
 
Crowd sourced content that is contributed to World Heritage Encyclopedia is peer reviewed and edited by our editorial staff to ensure quality scholarly research articles.
 
By using this site, you agree to the Terms of Use and Privacy Policy. World Heritage Encyclopedia™ is a registered trademark of the World Public Library Association, a non-profit organization.
 


Copyright © World Library Foundation. All rights reserved. eBooks from Project Gutenberg are sponsored by the World Library Foundation,
a 501c(4) Member's Support Non-Profit Organization, and is NOT affiliated with any governmental agency or department.