Newsletter December 2014

Particle Sizing Webinar

2014 is drawing to a close, but before we thank you for another good year, we have collected some news from the world of particle analysis for you.

Webinar regarding particle sizing

Christmas is just around the corner, so we would like to invite you to a free webinar about the challenging field of particle sizing. Our CEO, Soren Lund Kristensen, has been invited to be the key presenter at Particle Technology Special Interest Group’s (PTSIG) last webinar of the year on December 16 at 10:00-11:00 GMT. Join the last webinar of the year by registering here.

Here, Soren Lund Kristensen will discuss why so many discussions arise about particle sizing results in a time where all equipment perform extremely well. The problem is not the standard of our equipment, but rather the methods of particle sizing. It is crucial that the method of use is developed uniquely to give an adequate description of the product.

No measurement is better than non-validated measurement

Though it is a regulatory requirement by all pharmaceutical manufacturers to develop a method for particle sizing and to have it validated, methods for each product doesn’t exist. Only with proper methods you get meaningful information, which can prevent big losses of cost and time. Even so, many seek to lower costs by taking over methods that are not properly developed, which easily can lead to misleading results and significant setbacks in the development. In fact, it would be better not to measure at all than to measure with non-validated methods.

“If you don’t use the right method of measurement, you could just as well roll a dice and let that be your result. That would be no worse than not developing a unique method for measuring your product. It is just the same as expecting the same result by dispersing sand and sugar, respectively, in water,” says Soren Lund Kristensen.

For more insight into the pitfalls of laser diffraction, join the last webinar of the year by registering here.

Authorities toughens up controls

Both the Danish Health and Medicines Authority and EMA are increasing controls of methods used for release thus tightening up demands for validation and method transferring. This is a result of more and more cases where pharmaceutical companies are using non-validated and properly transferred methods for release analysis.

“We are glad to see the authorities toughen up controls pharmaceutical manufacturers to make sure their methods used for release are fully validated and transferred – both to be in compliance and to avoid costly setbacks,” says Soren Lund Kristensen.

Last but not least, Particle Analytical has received a new GMP certificate by the Danish Health and Medicines Authority after a routine control in August. Please contact us to receive a copy of the latest certificate.

We hope to see you at the webinar next week. Thank you for another good year.

Merry Christmas and Happy New Year.