ISO 9001 accreditation a “huge step” for Prosonix

06-Jul-2009 - Last updated on 07-Jul-2009 at 15:14 GMT

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Ultrasonic particle engineering specialist Prosonix has been accredited under the ISO 9001:2008 quality scheme, after an inspection by the UK unit of independent auditing group SGS.

Prosonix’ business is based on a suite of ultrasonic particle engineering and process chemistry technologies that are used by drug and chemicals firms, including giants like Pfizer and UCB, to exert greater control of crystallisation and processing operations.

The new certification covers the management systems that govern Prosonix’ ultrasonic crystallisation and formulation operations as well as those used during its technology licensing activities.

Prosonix’ CEO, David Hipkiss, told in-PharmaTechnologist that: “This is a huge step forward,” adding that it enables the firm to manage all aspects of its business in the most cost and time efficient manner.

He explained that the audit, which took six months to complete and involved a significant amount of new training for the whole Prosonix team, has delivered several business improvements.

Key among these improvements is the new quality policy and objectives the firm developed particularly, as Hipkiss explained, because they were created organically by the whole team “and not simply dictated from senior management.”

He went on to say that: “Customers should take confidence in [the fact that] we are making strategic investments into the business as it grows to enable our continued success in the long term.

Pharma M&A activity

Hipkiss also spoke about Prosonix' performance in the global economic downturn, explaining that its turnover for the year ended March 31 was more than double that recorded in the previous fiscal year.

He predicted that: “While we expect to have another strong year, it is fair to say that with continued Big Pharma consolidation that some projects were put on hold pending company integration.

On the other hand Hipkiss said that: “Other mergers have actually accelerated some projects which we had not expected to progress so fast.”

“What is certain is that our pharma customers are increasingly focussed on understanding the full cost of production, and failure, from API synthesis to drug product in packaging.”