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USP <797> <800> Sterile Compounding | Common Design Pitfalls in USP <797> <800>

USP <797> <800> Sterile Compounding | Common Design Pitfalls in USP <797> <800>

What to do When Building/Renovating Your Pharmacy

Assemble the Team:

  • Architects
  • Compliance
  • Engineering
  • Infection Control
  • Nursing
  • Pharmacy Management
  • Pharmacy Technicians
  • Project Management

Common Mistakes

Resources:

  • Budget is not appropriate to deliver quality
  • Corporate leadership does not understand risk (operational and financial) if not properly planned and constructed
  • Pharmacy Management not supported with compliance expertise
  • Project is lacking key stakeholders

Design:

  • Airflows and Ventilation of Hazardous Drug (HD) Receipt, Storage and Mixing rooms
  • BSCs placed too close to ceiling HEPAs
  • Cleanrooms not sized for growth and redundancy
  • Inappropriate finishes including ceilings, floors, paint, walls, etc.
  • Inappropriate HVAC design yielding ongoing airflow issues
  • Lack of continuous monitoring devices for temperature, relative humidity and differential pressure
  • Misplacement of line of demarcation and sink
  • Not recognizing impact of process flows and storage in the design

Construction:

  • Lack of owner presence during the process
  • No operational and cleaning procedures in place
  • No process to verify as-built conditions to the approved design
  • Unprepared for construction delays

Post-Construction:

  • Incomplete commissioning, HVAC balancing and certification
  • Lack of comprehensive cleaning and environmental sampling prior to inspection
  • No staff training to ensure personnel and material workflows make the engineering controls effective

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Quality Solutions

Quality Solutions News & Announcements

Founded in 2001 as a validation services provider, Quality Solutions has grown into a leading compliance and support partner for the biotech, healthcare, and pharmaceutical industries. With offices in Maryland and Utah, we execute projects both nationally and internationally, offering tailored, cost-effective solutions to meet FDA regulations, USP 797/USP 800 guidelines, and broader quality management needs. Our comprehensive services—including facility design, calibration, validation, and environmental certification—ensure seamless compliance and operational efficiency. With an integrated certification team and in-house lab, we deliver fast, reliable results, minimizing risks and costly delays. At Quality Solutions, we take a long-term partnership approach, acting as your insurance policy for maintaining compliance while maximizing the financial return on quality investments.

RXinsider Staff

Posted by: RXinsider Staff

RXinsider is a multimedia publishing and technology company offering print publications, digital platforms, events, and content creation services to the B2B pharmacy market.

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