Process Containment & Surrogates
The use of low risk materials (surrogate) provides an opportunity to evaluate and measure the effectiveness of process containment controls and correct any deficiencies prior to introduction of a high potency material into the process. Bureau Veritas has capabilities to perform both field and laboratory services on process surrogate evaluations. These services include:
• Factory acceptance testing (FAT)
• Site acceptance testing (SAT)
A variety of surrogates are available, and which one is right for your project is dependent upon the application or particular process. Common surrogates include:
• Naproxen sodium
Surrogate sensitivities range from 0.2 nanograms to 0.1 micrograms per sample and include non-API materials for your consideration. Consultation on the appropriate surrogate for your application is available.