Bioprocessing
Accelerate your biologic drug development with Praesto®
chromatography resins.

Accelerate your biologic drug development with Praesto®
chromatography resins.
As the global leader in resin technology, we develop and manufacture small beads that are used in the most regulated industries in the world to separate, remove or recover very specific elements and compounds.
Learn MoreWith 40 years of manufacturing expertise and 30 years of regulatory experience, we supply leading separation, purification and extraction technologies to support chromatography and biocatalysis applications in healthcare and life sciences.
Learn moreWe are the world leader in resin-based separation, purification and extraction technology, that provides sustainable solutions for our environment, businesses and healthcare.
Learn MorePurolite Corporation in the USA is now ISO 9001:2015 certified.
August 31, 2018—Philadelphia, P.A., USA—Purolite’s headquarters in Bala Cynwyd, Pennsylvania and manufacturing plant in Philadelphia, Pennsylvania have successfully transitioned from ISO 9001:2008 to ISO 9001:2015. The audit was completed in the middle of June through BSI and the formal certificate was received August 30, 2018.
The initiative was led by Joe D'Alessandro, Purolite’s Quality Assurance and Quality Systems Manager at the Philadelphia facility. He notes, “The transition from ISO 9001:2008 to ISO 9001:2015 keeps the importance of improving systems first in mind." He adds, “Purolite is customer driven. This is what makes us a global industry leader. Keeping back-end processes as streamlined and transparent as possible is very important. Formalizing processes through ISO reinforces our to commitment of technical, operational and administrative excellence."
ISO compliance is not a law. It is a voluntary agreement to follow the standards for best practices that a company develops. It is a foundation for making the company’s products and services consistent across the organization, with an eye toward process improvement, evidence-based decision making, team involvement and customer satisfaction.
Although there is some alignment, the 2015 standard has some major differences from the 2008 standard, including a new focus on a “PDCA” cycle, which creates a system to follow for Planning, Doing, Checking and Acting to promote continuous and systematic improvement. There is also more emphasis on input and output of processes, the quality of those processes and the result. Additionally, risk/opportunity based thinking and further consideration of the ever-changing needs and expectations of suppliers, shareholders, internal customers, personnel and others has more emphasis in the new system. There are also changes to how knowledge is managed and maintained, and more structure for managerial conformance.
ISO standards are reviewed every 5 years by the global network of ISO standards representative bodies, and ISO 9001:2015 is the fifth revision of the ISO 9001 quality management system since it began in 1987.
The new certificate is valid until December 19, 2020.
Purolite would like to thank the internal ISO team for a job well done.
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