What are surrogates, and why do it?
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.
Partnering with Maxxam
Maxxam 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), Maxxam has the expertise to provide you with unparalleled analytical guidance and support.
Overview of service: Maxxam offers highly sensitive and specific sample analysis for air and surface samples collected during process surrogate containment studies. 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. Samples may be submitted for analysis “upon demand”, with a standard turnaround of 7 days from receipt of sample submissions. Confirmation of sample receipt is provided by email, as well as the analysis report in .pdf upon completion of analysis. Expedited service is available for a surcharge, which must be coordinated with the laboratory in advance of sample submission.
Relevant Certifications/Accreditations: The laboratory is accredited by AIHA-LAP to ISO 17025.
Instrumentation: Instrumentation is variable depending upon the particular surrogate application, but include LC/MS/MS, HPLC-FLD and Ion-chromatography with pulsed amperometric detection.
Sample report: provided as a separate attachment.