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Reducing Aseptic Risk During Filling

At #PDAannual, Novo Nordisk discusses innovative solutions to modernize aseptic filling in existing facilities while minimizing downtime, regulatory impact, and rebuild.

A prototype based on a single-click pump in collaboration with supplier NeoCeram.
A prototype based on a single-click pump in collaboration with supplier NeoCeram.

Traditional upgrades to aseptic systems can be difficult to implement in the short term, requiring significant rebuilds and long GMP-regulated manufacturing regulatory approval processes. During the 2021 Parenteral Drug Association (PDA) Annual Meeting, Thomas Busch, project director at Novo Nordisk–a pharmaceutical company that discovers, develops, and delivers medicines–spoke on the company’s efforts to modernize existing facilities for future technology setup without shutting down facilities for months or years at a time.

Novo Nordisk’s ambition is to rise to technology leader within manufacturing and IT operations. The company aims at continuous, automated, and closed production processes, with products instantly released by real-time quality control and assurance, and digitization of its value chain.

This ambition was showcased in a case study the company presented at the PDA Annual Meeting on aseptic risk reduction during filling. The expectation in the industry is to establish barrier systems on filling lines to reduce the risk of contamination during aseptic filling operations. Novo Nordisk sought to update facilities that still utilized a filling fluid pathway setup by connecting silicone tubing from the manifold to the pump and again from the pump to the filling needle. The company decided to eliminate such open aseptic connections during the setup of filling lines. 

Bypassing the traditional approaches–using a different pump principle to close the fluid path, including single use, or by introducing CIP/SIP which would require rebuilds or regulatory approval–Novo Nordisk opted to implement:

  • Clickable pumps that fit into place easily.
  • Pre-assembly of the system–pump, tubing, needle, and manifold–in the wash area.
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