Life Sciences
Toxicology Services
Broad toxicological support around occupational exposure and product safety in the life science research and manufacturing environment.
Trinity Consultants’ SafeBridge group is the premier environmental health and safety resource for the pharmaceutical research and manufacturing industries. We set the definitive standard for the toxicological evaluation and hazard assessment of drugs and drug products, ensuring that the products are safe and the people contributing to their development are protected.
SafeBridge’s team of board-certified toxicologists provide services to a variety of industries, with a focus on pharmaceutical, fine chemical, and laboratory workplaces. Our team develops health-based exposure limits and provides quantitative hazard assessment for worker and product safety. SafeBridge was involved in developing a system for categorizing compounds that has been adopted worldwide and used ubiquitously in the pharmaceutical industry for handling potent compounds safely. From risk assessment and communication to managing toxicology testing programs, we drive our clients’ success in solving their core occupational health and toxicology challenges.
ON-DEMAND TRAINING
Evaluating the Hazards of Pharmaceuticals: Basic Concepts
Join us for an introductory training on the various qualitative and quantitative methods available for hazard assessment and how they are used to evaluate the potential hazards of workplace exposure. We provide the background needed to understand methods of assessment, including OEBs, OELs, ASLs, PDEs/ADEs, and other occupational safety assessments.
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How Else We Can Help
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Expertise in chemical hazard classification, preparation of SDSs, and compliance with global hazard communication regulations.Our Results
Featured Projects
Trinity's SafeBridge Group Identifies Chloracne Source in Research Lab
SafeBridge investigated an outbreak of chloracne in a discovery lab at a top 5 pharma company, determined the novel compound responsible for the outbreak and recommended a safe course of remediation.
Pharmaceutical Leader Evaluates Safety and Quality of New Transdermal Patch
SafeBridge partnered with a global pharma company to design and perform extractables and leachables (E&L) testing and provide toxicological assessment of the results to assess the product’s safety and quality.Service Specifics
Toxicology Services
Hazard Assessment and Risk Communication
Trinity Consultants’ SafeBridge group evaluates occupational and environmental health risks from manufacturing and research operations and communicates risks to management, regulatory agencies, community, and employees. We conduct product safety risk assessments, utilize and interpret in silico models for toxicology screening, evaluate product contaminants and impurities, and advise on cleaning limits for a variety of contaminants.
Occupational Exposure Limits (OELs)
SafeBridge’s toxicologists develop scientifically valid safe limits for worker exposure to chemical substances and intermediates. Our team has established OELs for over 2000 pharmaceuticals for a wide range of biotech and pharma clients.
Health-Based Exposure Limits (HBELs)
SafeBridge establishes safe limits for the cross-contamination of drug products with other drug substances, process intermediates, residual solvents, and foreign substances. In addition to HBELs, these may be referred to as:
- Permitted Daily Exposures (PDEs)
- Acceptable Daily Exposures (ADEs)
Occupational Health Categorization and Banding
SafeBridge developed a system for categorizing compounds that has been adopted worldwide and used ubiquitously in the pharmaceutical industry for handling potent compounds safely. Our toxicologists categorize active pharmaceutical ingredients for occupational health purposes based on toxicity and potency according to established criteria and provide recommended handling practices for these compounds for laboratory, pilot plant, and production settings.
Safety Data Sheet Development
Our experienced SDS writers develop SDSs on active pharmaceutical ingredients, drug products, and key intermediates for employee and environmental protection and regulatory compliance. Some of our SDS writers are SDS registered professionals (SDSRPTM) through a program with the American Industrial Hygiene Association and the Society for Chemical Hazard Communication.
Extractables and Leachables (E&L) Evaluation
SafeBridge toxicologists evaluate the potential for chemicals to leach out of product packaging and processing components, setting acceptable limits for these potential contaminants in drug products. Where further testing is required to accurately evaluate risk, our team designs and oversees testing, assuring scientific rigor and presenting findings in reports that are designed to facilitate conclusive FDA reviews.
Environmental Risk Assessments
SafeBridge's experienced scientists prepare environmental risk assessments for investigational new drugs (IND) or new drug application (NDA) submissions to FDA, or marketing authorization applications (MAA) to the European Medicines Agency (EMA), according to current guidelines.
Child-Proof Packaging
Our team evaluates the failure criteria (F-Values) for child-proof packaging of pharmaceutical products. The result will determine whether a specific blister package design provides enough of a challenge to toddlers that will prevent access to a sufficient number of tablets or capsules without causing significant impairment of the child’s health.
Toxicity Testing
When toxicity testing is needed for products and key intermediates to assure employee safety, environmental protection, and/or regulatory compliance, SafeBridge identifies requirements and oversees testing to ensure the quality, integrity, compliance, and proper interpretation of data generated. This function is also supported by SafeBridge’s Toxicology Regulatory group.
Technical Support
The SafeBridge team evaluates the toxicity of chemicals for potential health effects, pharmaceutical cleaning limits, personal injury litigation support, worker's compensation assistance, product safety, and Proposition 65 compliance across a variety of industries. Some of these services are supported by SafeBridge’s Toxicology Regulatory group.