What are surrogates and why use them?
Surrogates are easily cleaned, low-risk materials with sensitive sampling and analytical methods which are substituted into a process in place of high potency or high risk materials. The use of process surrogates provides the means to assess the efficacy of controls, and correction of any deficiencies, before the introduction and handling of high risk materials.
Bureau Veritas offers the widest variety of surrogate method options and the best sensitivities possible. Selection of the best surrogate for your assessment is situational, depending upon a variety of factors. Having actively participated in writing of 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 you in selecting the best method for your particular situation, providing information and support, as well as sampling media and sample analysis. Our laboratory is accredited by AIHA-LAP to ISO 17025.