Industrial Hygiene & Safety Services for CDMO Pharma Company
Project Details:
KERAMIDA supported a pharmaceutical contract development and manufacturing organization (CDMO) during the retooling of an active production facility for new product lines. The project involved integrating new manufacturing processes and upgrading facility infrastructure, requiring a multi-disciplinary approach to health and safety compliance.
Our team provided targeted safety inspections and in-depth industrial hygiene (IH) assessments to address both construction-phase risks and operational hazards associated with new process implementation. In addition to typical daily safety walkthroughs, our involvement focused on process-specific hazard evaluations and strategic inspections aligned with critical work activities and construction phases.
Key services delivered included:
Performing industrial hygiene exposure assessments related to chemical use, cleaning agents, and pharmaceutical compounds, including air sampling and qualitative exposure evaluations.
Reviewing and advising on control strategies for airborne contaminants, including engineering controls (e.g., local exhaust ventilation, process order, standard operating procedures, etc.), PPE requirements, and administrative practices.
Conducting focused safety inspections during high-risk construction activities such as structural tie-ins, utility upgrades, and equipment installations. These inspections also included confined-space atmospheric monitoring.
Providing compliance support with OSHA General Industry and Construction standards, particularly in areas involving confined space entry, LOTO, chemical handling, and contractor safety management.
Assessing hazards and providing ergonomics recommendations.
Participating in process hazard reviews and pre-startup safety evaluations to ensure health and safety considerations were addressed prior to commissioning new systems.
Project Goals Achieved:
KERAMIDA worked closely with the client’s internal EHS team, construction managers, and subcontractors to build a coordinated compliance strategy that balanced the complexities of pharmaceutical operations with the dynamic nature of construction activity. Our contributions helped the client maintain regulatory compliance, protect worker health, and ensure safe integration of new production capabilities.
Related Services:
KERAMIDA is a leading health and safety services consulting firm with decades of EHS experience. KERAMIDA provides expert industrial hygiene assessment and management of hazards including chemical, physical, radiological, biological, and ergonomic stressors. Work is overseen by CIH certification holders.
KERAMIDA is a leading health and safety services firm with decades of EHS experience. We help companies manage risk, assure OSHA compliance, and improve health & safety performance. We are experts in silica exposure, H&S program development, ISO 45001 Occupational Health & Safety MS, audits, and training.
