Bureau Veritas 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 working days from receipt of sample submissions. Confirmation of sample receipt is provided by email, as well as the analysis report in PDF format upon completion of analysis. Expedited service is available for a surcharge, which must be coordinated with the laboratory in advance of sample.
1. What are my surrogate options?
By definition, any material which can be substituted for another in a process can be used as a surrogate if it meets the following conditions:
• It behaves similarly to the material being substituted (both in the process and as an aerosol)
• It does not adversely affect the process or equipment
• There is an adequately sensitive sampling and analytical method available to measure it
Ideally, the surrogate will also be:
• Readily available and inexpensive
• Easily cleanable
• Pose a low risk hazard to people, equipment and facilities
• Pose a containment challenge equal to or greater than the material it is modeling
The most commonly used surrogates are: Lactose, Naproxen sodium, and Mannitol. Other common options include Acetaminophen, Riboflavin, Sucrose and Trehalose. The best surrogate option is a situational decision, depending upon a variety of selection drivers. Our Process Surrogates and Dusting Testing presentation outlines selection drivers and potential concerns for each of these surrogates.
2. How do I get information on sampling and order sampling media?
Sampling media is provided and included in the cost of analysis, and can be ordered online or by contacting our laboratory directly.
3. Does Bureau Veritas provide bulk surrogate material to use in containment testing?
Bureau Veritas does not provide the surrogate for the test. If seeking gram quantities, they can be ordered from many laboratory chemical supply companies. For tests requiring Kg or higher quantities, acquisition through approved excipient suppliers of registered pharmaceutical companies is the best and most economical option.
For more information, please contact:
Matt Meiners, CIH
Pharmaceutical Industrial Hygiene Laboratory
95 Oakwood Road
Lake Zurich, IL 60047