Process Containment & Surrogates

Bureau Veritas’ center of excellence in Lake Zurich has successfully adapted industrial hygiene methods to address surface sampling for housekeeping, product contact surface cleaning validation purposes, and plant decommissioning projects.  Analysis can be performed from swipes, swabs or rinses. Process containment control can be evaluated through the use of process 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:

   •    Lactose
   •    Mannitol
   •    Naproxen sodium
   •    Riboflavin
   •    Acetaminophen

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.


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