Monday, 19 November 2018

New Developments with Sterile Disposable Technology and Single-Use Systems for Aseptic Processing

In the past three to five years, there have been a number of advances in single-use sterile, disposable technologies, which have helped to both reduce the risk of contamination and to streamline process operations. The majority of these technological developments are oriented towards the manufacturing of sterile products, particularly aseptically filled products.

In relation to this, Tim Sandle has written a review paper. The introduction is:

The advantages of single-use technology can be summarised as: eliminating the need for cleaning; removing the requirements for the pharmaceutical company to perform in-house sterilization (typically by autoclaving) for all components; reducing the use of cleaning chemicals; assisting with storage requirements; lowering process downtime; and increasing process flexibility and reducing risks of cross contamination. However, single-use technology is still, to an extent, in its infancy and there are a number of validation steps which need to be undertaken before such technology is adopted by a pharmaceutical manufacturer11. These include assessing any leachables or extractables which might arise when the product comes into contact with the single-use technology. The presence of extractables could lead to adulterated product or to the inhibition of any microbial contamination (leading to a false negative result). Other disadvantages are in the availability of the technology (in that not all sizes or types required by pharmaceutical manufacturers are available) and development costs.

This paper examines some of the types of single-use technology available and addresses some of the steps required by pharmaceutical manufacturers to bring the technology online. 

Sandle, T. (2018) New Developments with Sterile Disposable Technology and Single-Use Systems for Aseptic Processing, BioPharma Asia, July / August, pp30-34 - see:

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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