SDTech will use Malvern’s mobile Insitec Voyager particle analyser for both its in-house development operations and during visits to pharmaceutical industry clients as part of its process optimisation service.
The unit is a laser diffraction particle size analyser for dry powder streams in the 0.1 - 1000 microns size range capable of accurately determining the size of up to four particles per second as milling is in progress.
SDTech CEO Jalil Benabdillah told in-PharmaTechnologist that the systems’ on-line monitoring capabilities were a key driver for the deal, explaining that: “The flow of information helps build a quality audit database very useful in case of claim.”
He added that the decision to add particle size analysis is in response to customer demand for improved quality control and stressed that the ability to monitor while milling removes laboratory analysis steps, helping save money on each run.
Dr Benabdillah went on to say that the ability to quantify particle size on the factory floor “also gives us a clear indication of the end point" that is not reliant on assessment by an experienced operator.
He added that, in addition to being recommended by the US Food and Drug Administration (FDA) “particle size analysis is necessary to predict variation in processing time…and the main parameter at the end of milling and micronising.”
Benabdillah was unable to say with which pharmaceutical firms SDTech was working with the Voyager system for reasons of confidentiality but was confident that particle size analysis will generate additional revenue.
Malvern will work with SDTech to provide support services for use of the technology both in house and for external clients. Oliver Schmitt, business line manager for process systems at Malvern, predicted that the relationship will benefit both firms.
"Our process systems are used in those industries that SDTech serves and with the advent of the mobile Insitec Voyager Malvern also offers a consultancy package for particle sizing. By incorporating the Voyager into appropriate SDTech projects, clients will receive a truly comprehensive service."