Pharmaceutical Industrial Hygiene
Bureau Veritas analyzes for over 1000 APIs and hazardous drugs (HDs) from the NIOSH list. We offer a complete solution for your pharmaceutical industrial hygiene needs including:
Active Pharmaceutical ingredients
WHAT ARE APIS AND SHOULD I BE CONCERNED ABOUT THEM?
Active pharmaceutical ingredients (APIs) are defined as any substance or a mixture of substances that when used in the production of a drug, becomes an active ingredient in the drug product.
Unlike most chemical hazards in the workplace for which health effects upon exposure are incidental, the purpose of an API is to have the maximum biological effect, typically with the lowest dose possible (potency). Therefore, monitoring, assessment and control of employee exposure to potent APIs is a significant concern in any operation handling these types of materials.
Bureau Veritas provides analytical services to the Life Sciences Industries: pharmaceuticals, bio-pharm, medical device and clinical work environments; and has been doing so for decades. We offer the largest number of highly sensitive and specific air and surface sampling analytical methods of any commercial laboratory in the world for APIs, Isolated Process Intermediates (IPIs), as well as many process chemical agents and solvents.
Our laboratory utilizes a number of different instruments including LC/MS/MS, UHPLC-DAD/FLD/CAD, HPLC-DAD-FLD, IC-EC and a variety of less common technologies and is accredited by AIHA to ISO 17025.
ChemoAlert is a surface sampling kit used by hospitals, pharmacies, infusion centers and anyone who handles chemotherapy drugs in the U.S. and Canada, to regularly test for drug residue. If gone unnoticed, workers may be exposed to antineoplastic drugs, which could be harmful to health over time. ChemoAlert was specifically designed in compliance with USP <800>, a regulated standard that drives the safe handling of hazardous drugs (HD), to help you safeguard your healthcare workers. To comply with USP <800>, testing is recommended every 6 months in the U.S.
Method Development - Pharma
METHOD DEVELOPMENT FOR APIS, PROPRIETARY CHEMICALS, AND INTERMEDIATES
Bureau Veritas provides method development and validation services for a wide variety of compounds for which sampling and analysis protocols are not available. The service is applicable for active pharmaceutical ingredients (APIs), proprietary chemicals and intermediates, as well as final products in the client pipeline. We use the latest technology in high pressure chromatography, mass spectrometry, elemental analysis, optical analysis, and Ion Chromatography to provide Industrial Hygiene solutions to challenging compounds.
Bureau Veritas has developed methods validation acceptance parameters in accordance with guidelines from OSHA and NIOSH. Within that framework, protocols can be customized to meet the validation requirements for your project. For pharmaceutical applications, assuming you do not have a defined method validation protocol for new methods, we suggest the following protocols to define scope and validation criteria: LC and LC/MS methods, Adaptation of HPLC to LC/MS to Enhance Sensitivity, Adaptation of Air Sampling Methods to Surface Applications.
OpiAlert is a surface sampling kit used by U.S. customs officials, police and first responders to accurately detect opioid drug residue. It can identify up to 22 compounds on a surface (including 21 opioids) and quantify the suspected contamination. Surfaces can also be re-sampled after decontamination efforts to determine the effectiveness of remediation procedures.
WHY CONDUCT OPIOID TESTING USING OpiAlert?
According to the Drug Enforcement Administration, 2-3 milligrams of fentanyl is enough to cause respiratory depression, arrest and possible death – a measurement equivalent to 5-7 grains of table salt. This poses a significant health risk to first responders, including law enforcement, emergency medical technicians, and crime lab analysts who could be potentially exposed to opioids while on the job. An important step in mitigating this risk is to identify and accurately measure opioid drug residue on the surfaces they interacted with.
WHAT DOES THE OpiAlert KIT INCLUDE?
The easy-to-use kit, proprietary to Bureau Veritas, includes everything you need to collect viable samples from multiple surfaces: swabs, vials, templates, wetting agent, gloves and an ice pack to maintain sample integrity during shipping and storage. After collecting samples from typical workplace surfaces, the swabs must be shipped to our AIHA-LAP accredited laboratory for analysis, with results available typically within 7 business days.
A kit can be purchased for $75 including taxes and shipping; all kit sales are final. Our pricefinder provides a breakdown of the cost for testing, based on the number of tests, as well as the number of samples.
WHICH OPIOIDS CAN BE ANALYZED USING OpiAlert?
A single swab can detect up to 22 compounds, including 21 opioid drugs:
As each kit includes 10 vials and swabs, you can detect a combination of up to 220 compounds across multiple surfaces using just one kit. With a detection limit of only 1 ng/sample, OpiAlert also offers superior analytical sensitivity and specificity compared to similar products.
Want to test for compounds that are not on the list? No problem. We have analytical methods available to test for 1000+ compounds individually, although some restrictions may apply. Please refer to our Pharmaceutical Fee Schedule for more information.
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.