Pharmaceutical Technology Europe - March 2010 - (Page 6)

Engineering trends and developments in lyophilisation Lyophilisation is an expensive process that demands high investments in technology, but for many products, pharmaceutical freeze drying is currently the only method to ensure durability. The high costs associated with this process, however, have provided companies with incentives to find ways of making lyophilisation more economical and efficient. which is used to sterilise the freeze dryer between batches. The freeze dryer must also be cooled down again afterwards. Because of this, there has been a move to provide systems with improved control units and optimised dimensions. For all phases combined, the latest lyophilisation machines can reduce the overall turnover time from 16–20 h to 8–10 h, depending on machine size. New systems also automate the testing of all functions, and offer improved software and control units. development potential in pharma lyophilisation today lies in reducing energy and resource consumption. In particular, water, nitrogen and compressor engineering offer enormous potential for significantly reducing process costs. Therefore, wherever possible, without affecting safety, processing times, consumables and masses of the freeze dryers are reduced. It is only in recent years that a great deal of attention has been devoted to reducing energy and resource consumption and, as such, approaches are still relatively new. Energy savings can be achieved by using alternative methods to steam sterilisation. As steam sterilisation means heating and cooling down the freeze dryer, there are increasing efforts to employ hydrogen peroxide to achieve energy savings. Other environmental approaches to freeze drying involve substituting greenhouse gases with natural coolants, such as ethane and propane. These can be used in freeze dryers within closed circuits as cascade cooling. However, there are disadvantages of natural coolants that must be taken into consideration; some are partly combustible, explosive and, therefore, need to be kept in defined atmospheres. These substances are not yet commercially available and are still being evaluated in R&D testing. PTE Reducing costs and time Freeze-drying systems can contain tons of stainless steel that has to be heated and cooled. One obvious way to reduce costs is to reduce the overall dimensions of freeze dryers — of both the containers and interior modules — because the larger the dimensions, the more energy is required, which is costly. The dimensions of a freeze dryer also affect turnover times; extensive use of steel means longer times for heating, Environmental protection Until recently, freeze drying was executed without keeping an eye on resources because safety was the only goal. Today, safety is still the absolute primary goal, but environmental protection has also become important. Indeed, the greatest Based on a contribution by Franz Bosshammer Business Manager at the Mornshausen site of Optima Group Pharma. To read the full version of this article, go to: www.pharmtech.com/bosshammer www.optima-packaging-group.de 1 CONTENTS 10 COMPUTER MODELLING 6 ENGINEERING TRENDS 11 A FUTURE ALTERNATIVE 7 FREEZE DRYER SELECTION 13 FREEZE DRYING BIOLOGICALS 8 FREEZE DRYER CLEANING 16 TOP TECHNOLOGIES http://www.pharmtech.com/bosshammer http://www.optima-packaging-group.de

Table of Contents for the Digital Edition of Pharmaceutical Technology Europe - March 2010

Pharmaceutical Technology Europe - March 2010
Contents
Key Considerations when Developing a Freeze-Dried Formulation and Current Trends
Engineering Trends and Developments in Lyophilisation
Selecting a Freeze Dryer
Cleaning Freeze Dryers
Computer Modeling the Freeze Drying Process
Vacuum H2O2 Gas Sterilisation in Lyophilisers: A Future Alternative?
'Thermal Fingerprinting': A Way to Optimise Lyophilisation
Freeze Drying of Biologicals
Developing a Safe Lyophilisied Adjuvant Vaccine
Measuring Headspace/Gas Concentrations and Residual Moisture Content
Eight Latest Technologies Showcased

Pharmaceutical Technology Europe - March 2010