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Departments

Center for Validation Technologies and Analytics

TOPICS

  • Optimisation and development of analytical methods  (UV-VIS, TLC, HPLC, UPLC, GC, dissolution testing)
  • Force degradation studies (UV-VIS, TLC, HPLC, UPLC, GC)
  • Validation, transfer of analytical methods and GLP analytics (UV-VIS, TLC, HPLC, UPLC, GC, dissolution testing, ICP/MS, ICP/OES, IC).
  • Qualitative and quantitative analytical testing of commercial products/goods with validated analytical procedures in GLP environment and issuing certificates of analysis and compliance.

ACHIEVEMENTS 2019

The Center for Validation Technologies and Analytics (CVTA, D-16) in 2018 adopted the activities of D05 in the field of ISO 17025, activities in the field of the National ethalon (NSI) holder. With the takeover of the activities, the CVTA from D05 also relocated the staff related to 17025 and NNE. At the same time we took over  also all the activities that D05 was performing in the field of GMP by the end of 2018. In connection with the NNE and ISO 17025 we obtained CVTA EU EMPIR project for the next three years. We were successful in all inspections and we received ISO 17025 certificate of suitability from Slovenian Acreditation agency.

By the year 2017 the business of CVTA was limited to the Slovenian territory, and in 2017 we completed the first international industrial research project, and in 2018 we acquired a total of three new industrial research projects from two different international industrial partners in the field of pharmaceuticals and pharmaceuticals production. The CVTA is involved in these projects as the project manager.

In 2018, we successfully concluded negotiations and signed contracts with the largest pharmaceutical customers and signed two new contracts, with which we started the cooperation. In any case, business with several different industrial partners is very important from the point of view of ensuring the scope of work, stability of business and also the corresponding financial result.

Analytical techniques that CVTA additionally perform on the market  include: section D04 (ICP-MS and ICP-OES, routine GMP analysis of SiO2 in different materials) and section D15 (NMR development and validation of analytical procedures and sample analysis).

In the coming years, we are focusing on the introduction of updated software to ensure the integrity of data and newer instruments in order to replace obsolete ones. Additionally, we are introducing an electronic diary and other activities in order to minimize paper operations. The goal is to achieve paperless performance by 2020 in the range of 90%.

In the field of other key activities of the KI, such as, for example, the education of personnel for the Slovenian industry, 5 experts were employed in the pharmaceutical industry within the the project of "industrial learning environment" which is also continued in 2019 to 2021. In 2018, we were able to hold two masters degree diplomas in CVTA, one of which was completed in 2018 and the second was  completed in 2019.

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