General Information

Our Partners

Product Literature - Chromatography

Product Literature - Biocatalysis

Lifetech™​​​​​​​ Enzyme Immobilization Resins

Lifetech™ Ready-to-use Immobilized Enzymes

Publications and Studies

Technical Support

LIFETECH™ BIOCATALYSIS SERVICES

We offer a variety of services to aid you in improving your process. Contact us for expert,hands-on support with:

•    Immobilization screening
•    Immobilized enzyme sampling
•    Analytical method development
•    Immobilization scale-up
•    Immobilization optimization
•    Site visits for hands-on technical support
•    Report writing

Click the orange ‘Contact Us’ button to talk to our Technical Support team.

CUSTOM RESIN-DESIGN PROJECTS

We have one of the widest portfolios of 'off-the-shelf' chromatography and biocatalysis resins in the world, available in a wide range of base matrices and functionalities. As such, we usually have the ideal resin for you. 

However, for certain applications we are able to utilize Purolite-patented technology to offer custom-designed resins, tailored to your process. Contact our Technical Support team to learn more.

Click the orange ‘Contact Us’ button to talk to our Technical Support team.

BIOPROCESS COLUMN PACKING SUPPORT

Our dedicated bioprocessing column packing suite is equipped with best-in-class pilot and process-scale equipment commonly used for mAb purification. Here, we provide expert, hands-on training to increase your packing success rates at both pilot and process scales, as well as demonstrate scale-up performance of our Praesto® agarose-based mAb purification resins.

Whether you use manual or automated packing methods, talk to us today for guidance on topics such as packing/unpacking, column priming, pressure flow testing, efficiency testing and slurry/buffer preparation.

Click the orange ‘Contact Us’ button to talk to our Technical Support team.

Bioprocess Industries Programme Modular Training 

Product Certification

Food and Drug Administration & EC ResAP (2004)3

The Purolite Romanian manufacturing facilitiy is US-FDA inspected for the production and distribution of APIs. Products used in food and beverage consumption comply with ResAP (2004)3 and/or FDA 173.25 and 173.65 regulations.

Establishment Inspection Report
Establishment Registration Renewal Certificate
Current Good Manufacturing Practice Certificate
Resolution ResAP (2004)3
FDA 173.25 Ion Exchange Resins
FDA 173.65 Adsorbents 

Halal Certification

Purolite produces Halal products under the supervision of several respected Islamic Councils.   

China  |  Romania  | United States

The Indonesian Council of Ulama, has also declared the China manufacturing plant to be Halal certified. Download the MUI certification for the China facility.

China

Kosher Certification

Purolite manufactures products in compliance with kosher production and packaging rules. Visit Kosher Certification and search Purolite for a complete list of our kosher-certified products

TSE/BSE

All manufacturing and packaging equipment, raw materials and processing aids used in producing the below Purolite enzyme carriers comply with Annex IIIa of Directive 2000/13/EC, amended by Directive 2007/68/EC and are free from Transmissible Animal Spongiform Encephalopathy (TSE/BSE) or Genetically Modified Organisms(GMO) or Allergens.

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Regulatory Information

Regulatory expertise throughout the product life-cycle is essential to identify regulatory options for product development, optimize ‘speed to market’ and produce a product that meets customer needs.

View our Regulatory Information brochure for information on existing regulatory approvals.

Environmental Health and Safety Certification

Classification, Labeling and Packaging (CLP) Regulation

Purolite complies with the EU regulation (EC) N0 1272/2008 CLP, to ensure that hazardous mixtures are clearly communicated through product classification, labeling and packaging.

ISO Certification

Purolite facilities are certified by the International Organization for Standardization (ISO), guaranteeing our products are manufactured to meet consistent high quality standards. Download the ISO 9001:2008 or ISO 9001:2015 certification for each manufacturing plant. 

Brazil  |  China  | Romania  | United Kingdom  | United States

Download ISO 14001:2015 certification for Purolite's laboratory in Wales.

United Kingdom

OHSAS 18001 Certification

Purolite Ltd, Llantrisant, United Kingdom and Purolite S.R.L. Victoria, Romania are certified to operate in compliance with the requirements of BS OHSAS 18001:2007.

Download PDF

REACH Compliance

Purolite is fully aware and committed to REACH, and confirms its compliance with this European Regulation.

Read our Statement of REACH Compliance

RoHS Certification

Purolite certifies that our products are in compliance with the EU Directive 2015/863 on the Restriction of Hazardous Substances in Electrical and Electronic Equipment (RoHS 2).

View Compliance Statement