Biological tests

Detection of bacterial endotoxins

Detection of bacterial endotoxins in medicinal products, raw materials, input materials and medical devices is performed in accordance with the requirements of the European (Czech) Pharmacopoeia, Article 2.6.14, AANSI AAMI ST72:2019, ISO 11737-3 and the American Pharmacopoeia, Articles ⟨85⟩, ⟨161⟩.

  • Gel clot method – limit test (Method A)
  • Kinetic turbidimetric method – quantitative test (Method C)

Our services are performed within the accreditation regime according to ČSN EN ISO/IEC 17025.

References

"ITEST is regularly audited by BIOPHARM without significant or critical findings, and is regularly ranked in the highest category in supplier evaluations. Exemplary long-term cooperation provides us with a guarantee of reliability and trust in the quality of services provided."

BIOPHARM

"We started our cooperation with Itest Plus s.r.o at the very beginning of its operation. For almost 30 years, we have been using laboratory services for our own purposes or for contractual testing of our customers' products. We greatly appreciate the professionalism, flexibility and reliability of the entire laboratory team. We would like to thank you for your cooperation so far and look forward to the future."

SVUS Pharma a.s.

"Ferring-Léčiva, a.s. is a company producing sterile and non-sterile medicinal products. We have been cooperating with the ITEST Plus, s.r.o. laboratory for more than 25 years, this cooperation is very valuable to us and we are very satisfied with the range of services and their implementation. The ITEST Plus company offers a wide portfolio of accredited tests, its employees are kind and helpful and respond quickly to all suggestions."

Ferring-Léčiva, a.s.

"We have been cooperating with ITEST plus s.r.o. for many years and are very satisfied with the service, quality of services and communication."

Cayman Pharma

"Itest Plus s.r.o. is for us a synonym for excellent cooperation in the field of laboratory analysis. Professional approach, excellent communication, reliability, speed and accuracy of tests are the calling card of this company and for us the main reasons why this company has been our trusted partner for more than 26 years."

Teleflex

"ITEST provides BIOPHARM with output control of the final product, intermediate products, input raw materials, packaging materials and microbiological monitoring of production areas. The tests are carried out within the scope of sterility and microbial safety tests in accordance with Ph.Eur. and in accordance with the valid contract."

BIOPHARM

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