The SafeBridge laboratory has developed or modified industrial hygiene sampling and analytical methods to help our clients meet their workplace air monitoring requirements. Our methods achieve high sensitivity and high recovery rate through the proper choice of filter media and extracting procedures as well as the optimization of air and surface sampling parameters.
The methods are validated with respect to analytical detection limits, precision and accuracy. Data on the stability of compounds relative to airflow volume and storage conditions and recovery off of surfaces are contained in these methods.
- Method Development and Sample Analysis - Routinely develops methods and analyzes industrial hygiene samples for biologically active pharmaceuticals such as steroids hormones, peptide hormones, antibody drug conjugates (ADCs) and cytotoxic compounds.
- Analysis of Potent Compound Surrogate Materials - Analyzes samples for verification of containment systems. We typically use naproxen sodium, mannitol and lactose as surrogates with a limit of detection as low as 50 pg of material on a filter. Insulin, with a limit of detection of 200 pg per filter, may also be used as a surrogate when ultra sensitivity is required, or as a surrogate for high molecular weight component.
- Cleaning Method Development - Conducts assessments of cleaning methodologies that are employed for both occupational settings and for QC/QA cleaning validation purposes.
- Permeability Studies - Conducts permeability studies of potent pharmaceutical compounds through gloves and other protective equipment materials.
SafeBridge Laboratory is accredited by the American Industrial Hygiene Association Laboratory Accreditation Programs (AIHA-LAP, LLC) for the analysis of active pharmaceutical ingredients. AIHA-accreditation means the following:
- Operating a quality system that meets the requirements of the International Organization for Standardization (ISO) Standard ISO/IEC 17025. This standard incorporates the principles of ISO 9001 that are relevant to the scope of testing services addressed by the laboratory.
- Operating a laboratory in which sampling and testing procedures are performed with adequate controls by well-qualified personnel using appropriate equipment, Standard Operating Procedures and validated methods.
- Maintaining an ongoing Proficiency Testing (PT) program.
- Participating in an independent third-party auditing program to ensure compliance with requirements.
If you wish to submit a sample, please follow these sample submission procedures. For more information on the capabilities of our laboratory, please contact SafeBridge at email@example.com.