Purolite Life Sciences has adopted software from Ideagen as it looks to enhance quality and compliance processes at its new manufacturing, research, development and quality center of excellence site based in South Wales.
The company, a leading manufacturer of ion exchange, catalyst, absorbent and specialty high-performance resins, will roll-out Ideagen’s Q-Pulse throughout its site in Llantrisant, Wales.
Q-Pulse will manage processes behind the operational manufacture and compliance requirements of Purolite’s products, including its new agarose product range, Praesto®.
The Praesto range is designed to help lower early phase clinical trial development costs, and improve the security of supply and productivity.
Mark Price, Regulatory and Quality Corporate Manager at Purolite, said: “The project with Ideagen is a major investment as we are looking at the agarose market and see our future operating within the likes of the Biotech Industry; a high value, heavily regulated industry.
“As it stands, we are competing for core business with competitors from China and India. This project with Ideagen and the move into the Biotechnology Industry is also a business continuity project, as well as one to completely modernize our process management.”
Andrew Betts, Purolite’s Site Quality Lead, added: “As part of the development of our new Praesto products we will be adopting Q-Pulse to control, and monitor all aspects of our QMS from documented information to planned preventative maintenance activities. Previously, process interfaces may have been restricted. Now, Q-Pulse enables us to directly interact across the platform's capabilities; audit findings can be raised directly against documented information, and escalations like deviations and out of specification are directly linked to process, product and even the supplier. It really has promoted a process approach to our QMS and supported ISO9001:2015 transition.
“The system will allow for more formal and compliant standardization. I also find it invaluable as a communication platform. It really delivers and promotes the message of quality across the organization.”
The project with Ideagen comes as Purolite looks to expand its operations in biotechnology – with future plans to utilize the Q-Pulse system within its sites in Romania, the United States, and China.
Mark said: “The next focus following our Wales implementation will be our Romanian site because of the FDA and high compliance requirements. The site is also certified to EU GMP, for the manufacture of APIs.”
Purolite Life Sciences was launched to expand into increasingly regulated industry sectors such as Biotechnology, cosmetics, food, and pharmaceuticals.
“There was a natural progression from our typical industry sectors to where we are now,” explained Mark. “Because of our work with APIs we became exposed to the pharmaceutical and biotechnology market, and due to our expertise in manufacturing high quality and functional beads, progress was made in the market quite quickly. Now, a lot of the major pharmaceutical and biotech companies are our customers, and we have started working on projects for them from our Welsh site.”
Ideagen provides quality, safety, audit, performance and risk management software and expertise, and has operations in the UK, the European Union, the United States, Middle East and Southeast Asia. Its suite of software applications helps the world's leading brands to improve operational efficiency, strengthen compliance and oversight, and anticipate and manage risk.
Q-Pulse is Ideagen’s quality, compliance, and operational risk management software application that is used by thousands of organizations globally. Currently, more than 200 Life Science organizations worldwide use the software for quality and compliance management.