Sortis pharma provides expert testing and consulting services to assess the safety and integrity of extractables and leachables in pharmaceuticals, single-use production process materials, container closure systems, and medical devices. These are carried out in accordance with FDA/EMA, BPSA, PQRI and ISO 10993 regulations
Our services for extractables studies include:
Professional project management
Semi/non-volatile screening by high mass accuracy LC/MS and LC/MS/MS (down to 1 µg/L)
Semi-volatile screening by PTV-GC/MS up to molecular weight of 700 (down to 1 µg/L)
Volatile screening by HS-GC/MS up to molecular weight of 300 (down to 20 µg/L)
Highly automated workflow for compound identification and semi-quantification in LC/MS and GC/MS screening
ICP/MS and ICP/OES screening of elements (down to 1 µg/L)
Our services for leachables studies include:
Professional project management
Validation of ICP/MS, ICP/OES, IC, GC/MS and LC/MS method for trace analysis (Full GMP compliance)