marzo 27, 2017

Quality Control Labs

Microbiology and chemistry laboratories

in 2016 35.000 analysis were performed internally. The company’s microbiology and chemistry laboratories have highly qualified personnel,  advanced instruments and equipment. Analytical procedures employed are capable of satisfying normative standards required by the customers: SIIT Labs operates in compliance with ISO 17025 and GLP

The chemical laboratory has all the  control instruments as HPLC, GC, IR, Spectrophotometer UV/VIS, Atomic absorption, Karl Fischer, Dissolution test, Disaggregator, Protein detection (DUMAS), Lipid extraction.

Microbiology laboratory, recently renovated, is designed in accordance with GLP indications for the pharmaceutical sector and is divided in separate areas with different contamination control classes depending on the type of activity taking place in each one

The technical competence, impartiality and reliability of the analytical data are attested by the constant participation in Proficiency Testing performed for different matrices.

The range of internal controls include:

  • Microbiological controls
  • Biological titrations and dosages
  • Identification assays
  • Chemical titrations
  • Determination of related substances
  • Controls of chemicophysical parameters
  • Determination of degradation products
  • Control of solvent residues
  • Dissolution & disgregation assays
  • Controls on primary packaging