Surrogates are substituted into a process in place of high risk materials to assess the efficacy of containment controls and correct any deficiencies before the introduction and handling of high risk materials. Surrogate testing is often conducted to protect a pharmaceutical facility, as well as its products and employees from contamination or cross-contamination. Surrogates are non-toxic substitutes that simulate the behavior of the active pharmaceutical ingredient they are replacing, are easily cleaned and have sensitive sampling and analytical methods.
According to your situation, determining which surrogate is most suitable for your pharmaceutical containment assessment depends on a variety of factors. Bureau Veritas offers the widest selection of pharmaceutical surrogate methods with the best possible sensitivities and can assist with selecting the optimal surrogate.
Having actively participated in writing the guidance document, “Assessing the Particulate Containment Performance of Pharmaceutical Equipment” (ISPE, 2005), Bureau Veritas has the expertise to provide you with unparalleled analytical guidance and support. We can assist in method selection, providing support and sampling media, and analyzing your air and surface samples. Bureau Veritas regularly provides advice on test methods and performs surrogate sample analysis for pharmaceutical manufacturers around the world.