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Fill-Finish Manufacturing Technology

Introduction of a drug product into a container/delivery system (and subsequent packaging) under aseptic conditions is essential to guarantee safety and efficacy. Challenges to fill/finish processes include maintaining sterility of components, equipment and production areas. This section presents papers considering equipment, processing and related topics.

Manufacturing – Receipt and Inspection of NovaPure® Plungers and Stoppers
This video presents recommended methods to receive and inspect/qualify (endotoxin, particulate, visual) plungers and stoppers.  West can assist Customers in developing these methods.

Manufacturing – Receipt and Entry of NovaPure® Plungers and Stoppers
This video presents recommended procedures to receive plungers and stoppers and introduce them into sterile manufacturing facilities – from Grade D through Grade A.  West can assist Customers in developing these procedures.

Parenteral Advisory:  Outmoded Fill/Finish Technology 

R. Hernandez.  BioPharm International, 29 (9), 14-21 (2016)


This article discusses how proper selection of fill/finish equipment and processes can minimize risk of recalls.

Link: http://www.biopharminternational.com/parenteral-advisory

Best Practices for Sterility Assurance in Fill/Finish Operations.

R. Hernandez.  BioPharm International, 28 (11), 14-19 (2015)


In this article, industry experts discuss strategies to operate fill-finish operations with best maintenance of sterility.

Link: http://www.biopharminternational.com/best-practices-sterility-assurance-fillfinish-operations

Fill/Finish Capacity Use for Biologics.

E. Langer.  BioPharm International, 28 (1), 14-17 (2015)


This article considers some of the fill/finish issues particular to biologic drug products, vis-à-vis pharmaceutical products.

Link: http://www.biopharminternational.com/fillfinish-capacity-use-biologics-0


Vial filling operation
Link: http://link.brightcove.com/services/player/bcpid441621462001?bckey=AQ~~,AAAAR_6EyKk~,0TvV7chvd1dziuglB5sL4R1p0gNxfSQr&bclid=0&bctid=906001136001

Syringe filling operation
Link: http://link.brightcove.com/services/player/bcpid441621462001?bckey=AQ~~,AAAAR_6EyKk~,0TvV7chvd1dziuglB5sL4R1p0gNxfSQr&bclid=0&bctid=906001140001

Aseptic stopper transfer – inside opening
Link: https://www.youtube.com/watch?v=ASwQwN7uwBg

Aseptic stopper transfer – outside opening
Link: https://www.youtube.com/watch?v=holkeDmp3qM

Port functionality
Link: https://www.youtube.com/watch?v=UDBTijVp0w0&feature=player_embedded

Biologics manufacture
Link: https://www.youtube.com/watch?v=bzvs_rBR9ug

Daikyo Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd.

NovaPure® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.