ALS Scandinavia - Trace Metal Analysis for Impurities by HR-ICP-MS

ALS Laboratory Group is based in Sweden and is one of the worlds leading contract laboratories for trace metals analysis. Our service includes every step from drug development with the trace metal analysis of raw materials, solvents and reagents to the quality control of APIs, products and method validation.

Clients are assured a state-of-the-art service in our clean room laboratory equipped with an unparalleled eight high-resolution HR-ICP-MS instruments. The laboratory follows a stringent quality regime and is accredited according to GMP. An inspection by the FDA was successfully completed in November 2008.

Trace metal analytical services

Our main focus is analysis of impurities in:

• Raw materials, water, reagents and solvents
• APIs
• Excipients
• Products

In addition we offer the following services:

• Method development
• Method validation
• Analysis according to international pharmacopoeia methods.

Trace metal monitoring laboratory facilities and services

Our laboratory in Sweden is purpose-built to facilitate trace metal monitoring under clean room conditions. In order to minimize background levels of contamination all fittings in the building, as far as possible, are made of wood or plastic.

Cleanroom clothes are worn and the use of make-up and other cosmetics is banned. Needless to say incoming air is filtered through HEPA-filters and instruments are kept at constant temperature. All water and acids used are supra-pure distilled in-house.

High-resolution ICP-MS instruments

High-resolution ICP-MS instruments have an unsurpassed detection capability compared to standard ICP-MS instruments. While normal ICP-MS instruments offer detection in the low ppb range, HR-ICP-MS instruments offer low ppt levels. Perhaps of more importance is the capability to instrumentally resolve interferences by high-resolution operation. This is especially the case with platinum group elements, which are a concern for many manufacturers.

In order to keep delivery times short, ALS employs in-house service personnel. Down-time is kept to a minimum and standard delivery times are less than 10 days for routine work.

PhD chemists will supervise the entire analytical process from receipt of samples in the laboratory to reporting of results. We believe that as a leading laboratory, educated staff are of paramount importance.

Although the ALS laboratory is a commercial contract laboratory, our chemists have published more than 100 publications in peer-reviewed journals. Over the last few years much of our research has been focused on clinical applications and isotopes.

Quality

While having one of the most technically advanced laboratories worldwide, we understand that a well developed quality system can not be replaced. As the foundation of our QA/QC system, we have accreditation according to ISO 17035. In addition to the standard ISO 17035 that we follow for all our operations, we are also accredited according to GMP.

If the client so requires, we can store samples in a fire proof cabinet for the requested time after the completed analysis. Raw data will be stored digitally for ten years, as standard or for longer periods if required by the client.

Proof that our quality system is "second to none" was received in November 2008 when the FDA performed an inspection at our laboratory. The inspection did not result in any FDA Form 483 Inspectional Observations.

The laudable reference list of ALS stretches into other segments. As one of only a few laboratories of its type in Europe, ALS has been listed by IRMM as an analytical service provider for the preparation and checking of certified reference materials.