Life Sciences

Compounding Pharmacy Program Support

Comprehensive USP <797> and USP <800> compliance support for compounding pharmacies and healthcare systems.

Hospital and health-system pharmacies are subject to robust regulatory requirements under USP <797>/<800> standards. Our engineering and cleanroom experts have helped hundreds of hospital and health-system pharmacies make the changes needed for safe and compliant sterile and hazardous drug compounding.

Trinity Consultants' Life Sciences division has the varied and deep expertise needed to provide timely and targeted support for organizations that compound medications to deliver life-saving treatments. As an integrated team, we offer solutions for the complete range of USP <797> and <800> challenges in sterile compounding pharmacies and healthcare facilities.

We help our clients balance operational challenges with regulatory requirements. With deep expertise in pharmacy operations, engineering and design, toxicology, and industrial hygiene as well as extensive health system industry experience, we have a proven track record in numerous facilities.

We support pharmacies and healthcare facilities in achieving compliance with USP <797>, <800>, <823>, <825>, and FDA 503 A & B pharmacy programs, for sterile compounding, non-sterile compounding, hazardous compounding, and radiopharmaceuticals. Our services include:

  • Design review and guidance based on years of experience with best practices and lessons learned
  • Cleanroom renovation workflow consulting, planning, and commissioning
  • Assistance with temporary and modular facilities and equipment and PEC selection
  • Differential pressure control design to minimize above action level EM results
  • Hazardous drug downstream contamination risk management
  • Pharmacy cleanroom SOPs and staff training guidance
  • Regulatory inquiry response and collaboration
  • Environmental monitoring program development and ongoing support
Our expert team includes decades of experience from senior-level consultants and engineers from Trinity acquisition companies WorkingBuildings and SafeBridge. With expertise in cleanrooms, sterile compounding, toxicology, and occupational health regarding active pharmaceutical ingredients, we help healthcare organizations ensure regulatory compliance and a safe environment for staff and patients.

Medical personnel fixing IV bag

Featured Insights

USP <797>/<800>

We have solutions for a complete range of USP <797> and <800> challenges in sterile compounding pharmacies and healthcare facilities. Protect your patients and your people, from blueprints to the bedside. 

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WorkingBuildings provided regulatory compliance, commissioning services, and much more to support the healthcare system's design and construction teams.