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Faced with increasingly strict regulatory pressures to improve controllability across all process steps, pharmaceutical companies are looking for ways to reduce the uncertainty in vial-to-vial nucleation during the freezing step known as lyophilisation.
At Linde, we have developed an innovative cryogenic technology to improve lyophilisation by controlling the nucleation temperature. This patented technology uses a sterile cryogenic ice "fog" to shorten lyophilisation cycles and improve product quality. VERISEQ® Nucleation gives pharmaceutical scientists a new degree of control over freeze-drying along with more robust lyophilisation cycles.
Diagram showing nucleation phenomenon
Thanks to our partnership with IMA Life, VERISEQ Nucleation can be implemented on virtually any freeze dryer – from laboratory to commercial-scale lyophilisers in aseptic and non-aseptic environments, regardless of pressure rating. Our flexible solution can be installed in new units, retrofit on existing systems and connected to multiple lyophilisers.
Benefits at a glance
• Effective controlled nucleation for greater vial-to-vial uniformity
• Shorter cycle times and reduced operating costs
• Improved product yield and quality
• Shorter reconstitution times.