KnowledgeBase Blog

Optical coherence tomography-based freeze-drying microscopy

A new type of freeze drying microscopy based upon time-domain optical coherence tomography is presented here. The microscope allows for real-time, in situ imaging of pharmaceutical formulations in vials relevant for manufacturing processes with a lateral resolution of <7µm and…

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Controlyo Nucleation Technology: Case Studies

ControLyo Ice Nucleation Technology, developed by SP Scientific and Praxair, is used to create favourable ice structures in products for freeze drying. Control of the ice structure can reduce concentration gradients, making the process less damaging to sensitive biological ingredients,…

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Method for Cryopreservation of Mouse Embryos

This presentation details a slow freeze/thaw method for cryopreservation of mouse embryos.

Controlled-rate freezers are used to pre-chill sensitive biological material such as embryos prior to long-term storage in liquid nitrogen. The manner in which the material is prepared, protected…

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Moisture Mapping in a Freeze Dryer

Regulatory authorities require proof that lyophilisation cycles are developed logically, and that they demonstrate uniformity. One measure of uniformity is residual water content throughout a batch. The amount of moisture remaining will be influenced by a number of factors including…

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Understanding Vial Washer Efficiency

October 2011

From Ger Smit, President of PennTech Machinery Corp

“How much water (WFI) does your washer use per hour?”

A simple question with insufficient information to be answered. The correct question is: “What is the minimum amount of WFI…

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Comparison of Lyo-Cycles

Comparison of Lyophilisation Cycles for a BNCT agent using “traditional” and “SMART(R)” drying

This study was carried out by the University of Strathclyde’s Institute of Pharmacy and Biomedical

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Logistics of Filling and Freeze Drying using Multiple Isolators

The use of isolator technology to fill and lyophilize pharmaceuticals presents many logistical challenges. However, through careful planning and well-deinfed procedures, Aventis-Pasteur were able to meet the challenges of producing sterile freeze-dried product in a pilot plant.

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Freeze-drying wet digital prints: An option for salvage?

On the occasion of the collapse of the Historical Archive of the City of Cologne in March 2009 and the ensuing salvage effort, questions were raised about the use of freeze-drying for soaked digital prints, a technique that has not…

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Challenges and Trends in Lyophilisation

Freeze drying is being increasingly used in both formulation development and manufacturing of pharmaceuticals for poorly solubles, biopharmaceutical molecules and, more recently, biosimilars.

Another trend is the growth in the number of siRNA and antibodybased formulations. These compounds regularly

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Relevance of Product Resistance on Primary Drying

Freeze drying is known to be a time consuming process with primary drying phases ranging from several hours up to weeks, depending on the product. During primary drying the product temperature at the ice sublimation interface (T p ) must…

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