Media Releases
Pernis first to manufacture European GMP-compliant solvents
19/09/2006
The adoption of Good Manufacturing Practice (GMP), to excipient ¹ level, for Isopropyl Alcohol (IPA) at Shell’s plant in Pernis in The Netherlands has made the European GMP-compliant product available for the first time.
New control and traceability measures implemented throughout the product supply chain ensure that the IPA-GMP² grade meets the quality assurance requirements for its use as excipient in pharmaceuticals, food and cosmetics.
IPA is a versatile, cost effective solvent that can be used in the preparation of a number of pharmaceutical products such as medicinal tablets and also disinfectants, sterilisers and skin creams. GMP standards require the implementation of a quality control system that covers the manufacturing, storage, supply and distribution of product destined for these applications.
“We expect to see GMP compliance eventually extended to chemicals in a wide range of pharmaceutical applications, as well in the production of food and cosmetics,” explains Sigrid Verstegen, regional IPA Product Manager. “As some of the world’s largest IPA producers, Shell chemicals companies wanted to demonstrate leadership in developing this capability in Europe.
“This is both a response to the growth of interest in GMP-compliant material we have seen from customers and our own desire to continually raise the quality of products we are able to offer.”
In order to meet the required specifications a number of physical changes had to be introduced at Pernis. The road tankers themselves are also dedicated to IPA-GMP² so there is no potential for product mix-ups and no need for cleaning between deliveries. This measure further reduces the risk of contamination.
The GMP implementation at Pernis is part of a developing global capability. Coen Wilms, Business Manager Solvents Europe, Africa and Middle East, says: “GMP compliance is already in place in Shell IPA plants in Canada and the US, and the measures we have put in place at Pernis means Shell chemicals companies are the first producers in Europe to offer this. The introduction of the IPA-GMP² grade in Europe is in line with our global leadership in Solvents and the principles of Responsible Care that we adhere to.”
For further information, please contact:
Shell Chemicals
Bianca Ruakere
+44 (0) 207 934 4506
Bianca.Ruakere@shell.com
Shell International Media Relations
Alex Wright
+44 (0) 207 934 3277
Alexandra.Wright@shell.com
¹ excipients are non-active ingredients used in the manufacture of pharmaceutical products
² meets excipient level of GMP
Notes to editors
What is GMP?
- Good Manufacturing Practice (GMP) regulations were initially developed by the US Food and Drug Administration and require manufacturers, processors, and packagers of pharmaceuticals, medical devices and some foodstuffs to take proactive steps to ensure that their products are safe, pure, and effective.
- GMP is a system for ensuring that raw materials and finished products are consistently produced and controlled according to quality standards. The system requires detailed procedures for each process that could affect the quality of the finished product, and documented proof that correct procedures are followed at every stage.
- This ensures that products are consistently produced and controlled to the quality standard appropriate to their intended use. This in turn protects the consumer from purchasing a product that may be ineffective or even dangerous.
- More information and guidelines on GMP can be found on the website of the International Pharmaceutical Excipients Council Europe: www.ipec-europe.org.
Shell and chemical solvents
- Solvents manufactured and marketed by Shell chemicals companies include various chemical solvents like Isopropyl Alcohol (IPA), Methyl Ethyl Ketone (MEK) and Methyl Iso Butyl Ketone (MIBK) as well as hydrocarbon solvents and glycol ethers.
- Shell Nederland Chemie BV operates petrochemical plants in Pernis and Moerdijk (The Netherlands).
- Shell chemicals companies sell IPA from plants in Berre (France), Pernis (The Netherlands), Deer Park, Texas (US), Sarnia (Canada), and in Bukom (Singapore).
Shell companies have their own separate identities but we may sometimes use "Shell", "Group, "we" or "us" when we refer to Shell companies in general or where no useful purpose is served by identifying any particular Shell company. Shell Chemicals collectively refers to the companies of the Shell Group engaged in the chemicals business. Shell chemicals companies manufacture and deliver petrochemical building blocks and polyolefins to industrial customers. These products are widely used in plastics, coatings and detergents.
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