About Purolite Life Sciences

Praesto Chromatography Guide - Discover the Praesto range

Praesto Protein A Resins

Praesto Ion Exchange Resins

Praesto Pure

Praesto Epoxy

Praesto CNBr

Praesto NHS

Praesto RoboColumns

Praesto MiniChrom Columns

Praesto HT Columns

Praesto 'Jetted' 35 µm High Resolution Ion Exchange Resins 

Praesto 'Jetted' A50 Jetted resins 

Evaluation of recent Protein A stationary phase innovations for capture of biotherapeutics

Reverse-Phase Chromatography, Adsorption and Solid Phase Extraction Resins

CGA & CGC Ion Exchange Resins

MDEA1 & MDEA2 Methacryclic Resins

Lifetech ECR Enzyme Immobilization Resins

Lifetech ECR Enzyme Immobilization Procedures
 

CalB Immo Plus™

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.

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. 

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

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.

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

Read our Statement of REACH Compliance

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

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 

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

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

Chromalite® Adsorbent Resins

Chromalite® Strong Acid Cation Resins

Chromalite® Strong Base Anion Resins

 

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 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.

Praesto®  Protein A resins - a short user instruction 

MAb platfrom processing experts from Purolite discuss key data from a recent HTPD comparability case study including yield, purity, DNA & HCP clearnace, and Protein A leakage.