ALS offers a comprehensive portfolio of pharmaceutical analyses comprising everything from raw materials, APIs and ingredients, intermediates, excipients and finished products. ALS has three GMP laboratories in Sweden and can offer broad pharmaceutical testing capabilities.
All three laboratories are highly specialized in their respective testing fields.
Elemental Impurities - Metals
Equipped with the most sensitive technique available (high resolution ICP-MS) and decades of experience in metals testing of pharmaceuticals, ALS in Luleå, Sweden is a reliable partner in elemental impurities testing. Our laboratory can offer method development, method validation and analysis of almost all matrices and at levels far below established PDEs.
The laboratory is dedicated to elemental impurites testing and our personnel have decades of experience working with high resolution ICP-MS technique. Operating the most sensitive analytical technique available, we are able to offer analysis of elemental impurities well under established PDE (permitted daily exposure). Method development, validation and analysis at 15-20 % of PDE is routinely performed at the laboratory. The instrumental park consists of 15 high-resolution ICP-MS (ICP-SFMS) ensuring a solid backup capacity.
Read more here.
Microbiology
The ALS laboratory in Sollentuna, Sweden provide a microbiological testing service to ensure raw materials, finished products, medical devices and production environments are safe from microbiological contamination.
Through our dedicated GMP compliant laboratory, highly experienced staff and extensive range of microbiological tests, ALS provides customers with cost effective quality assurance. The laboratory holds a GMP certificate and has been audited by the FDA.
Physical & Chemical Analysis
The ALS laboratory located in Landskrona offers numerous methods for physical and chemical analysis according to pharmacopoeias and can thus serve both Swedish and international clients. We can also offer client-specific methods for QC release as well as in-house validated analytical methods.
Stability and storage
ALS also offers stability studies at the Landskrona facility. Stability studies are used to evaluate the stability of a product under influence of various environmental conditions including temperature, humidity and light. Data from stability studies can be used to determine recommendations for containers, shelf life and expiry date of products.
Contact
E-mail: pharma.nordic@alsglobal.com
Luleå: +46 920 28 99 00 Sollentuna: +46 8 29 79 00 Landskrona: +46 418 707 00