United States Pharmaceutical

USP 797 Pharmaceutical Compounding - Sterile Preparations

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USP General Chapter 797 establishes standards for compounding sterile preparations to help ensure patient safety. ATEK's environmental monitoring solutions help pharmacies maintain the controlled conditions required for sterile compounding.

Authority: United States Pharmacopeia (USP)

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Why Choose ATEK for USP 797 Compliance

Maintain Sterile Conditions

Continuous monitoring ensures your cleanroom environment meets USP 797 requirements.

Support BUD Assignments

Documented storage conditions provide evidence to support your beyond-use dating.

Pass Board Inspections

Comprehensive documentation and audit trails simplify state board pharmacy inspections.

Protect Patients

Proper environmental control ensures compounded preparations are safe and effective.

USP 797 Requirements

Key compliance requirements and how ATEK addresses each one.

Requirement Description ATEK Solution
797.4
Facilities and Engineering Controls
 Facilities must maintain appropriate environmental conditions including temperature, humidity, and air quality.
Comprehensive Environmental Monitoring
Monitor temperature, humidity, and differential pressure across cleanrooms and controlled areas.
797.6
Environmental Monitoring
 A written environmental monitoring program must be established and followed.
Automated Monitoring Program
Pre-configured monitoring schedules with automated alerts and reporting support your written program.
797.7
Cleaning and Disinfection
 Procedures for cleaning and disinfection must be documented and followed.
Condition Verification
Document environmental conditions before, during, and after cleaning procedures.
797.14
Beyond-Use Dating
 BUDs are determined based on storage conditions and CSP category.
Storage Condition Documentation
Continuous temperature logging provides evidence that storage conditions support assigned BUDs.
797.20
Documentation
 All activities must be documented, including environmental monitoring results.
Automated Documentation
All monitoring data is automatically logged with complete audit trails for regulatory review.
797.18
Quality Assurance
 A QA program must ensure preparations are consistently produced to quality standards.
QA Reporting
Generate quality assurance reports showing environmental compliance trends and excursion history.

Understanding USP 797

USP General Chapter 797 provides the minimum standards for compounding sterile preparations (CSPs) to help ensure they are safe for patient use. The chapter applies to all settings where CSPs are prepared, including hospitals, compounding pharmacies, and physician offices.

2023 Revisions

The revised USP 797, effective November 2023, includes significant updates:

  • Simplified facility categories (Category 1, Category 2, and Category 3)
  • Updated beyond-use dating requirements
  • Enhanced environmental monitoring requirements
  • New cleaning and disinfection procedures

Environmental Control Requirements

USP 797 establishes specific requirements for:

  • Temperature: Temperature and humidity in compounding areas are monitored and documented at least once daily, and controlled to keep garbed personnel comfortable. Storage ranges follow USP <659>: CRT 20-25°C, refrigerated 2-8°C, frozen -25 to -10°C
  • Humidity: Should be controlled below 60% relative humidity to minimize microbial growth
  • Air Quality: ISO Class 5 for primary engineering controls, ISO Class 7 for buffer areas
  • Pressure Differentials: Positive pressure in buffer areas, negative pressure for hazardous drug compounding

For the full requirements with storage ranges, monitoring frequency and excursion handling, see our USP 797 temperature monitoring guide.

How ATEK Supports USP 797 Compliance

ATEK’s monitoring platform provides the environmental control documentation required by USP 797.

Comprehensive Parameter Monitoring

Monitor all critical parameters from a single platform:

  • Temperature in compounding and storage areas
  • Humidity in cleanroom environments
  • Differential pressure between classified areas
  • Alert on any parameter deviation

Documentation for Inspections

When state board inspectors arrive, be ready with:

  • Complete temperature logs for all storage areas
  • Environmental trending reports
  • Excursion documentation with corrective actions
  • Equipment calibration records

Support for BUD Assignments

Documented storage conditions are essential for beyond-use dating. ATEK provides:

  • Continuous temperature recording
  • Proof of proper storage throughout shelf life
  • Excursion alerts and documentation

Related Solutions

Explore ATEK monitoring solutions for USP 797 compliance.

Hospital Pharmacy

Automated temperature and environmental monitoring for hospital pharmacies.

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Cleanroom Monitoring

Differential pressure and environmental monitoring for cleanrooms.

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Biotech & Pharma

GxP-compliant monitoring for pharmaceutical manufacturing.

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USP 797 FAQs

What is USP 797?

USP 797 is a chapter in the United States Pharmacopeia that establishes requirements for compounding sterile preparations. It covers facility design, environmental monitoring, personnel training, beyond-use dating, and quality assurance to ensure patient safety.

What environmental conditions does USP 797 require?

USP 797 requires controlled temperature (typically 20C or cooler for compounding), controlled humidity below 60% relative humidity, appropriate air quality with HEPA filtration, and positive or negative pressure differentials depending on the type of preparation.

How does ATEK help with USP 797 compliance?

ATEK provides continuous monitoring of temperature, humidity, and differential pressure in cleanrooms and storage areas. Our automated documentation and alerting system helps pharmacies maintain compliance and quickly respond to any environmental excursions.

What storage temperatures are required for CSPs?

Controlled room temperature CSPs are stored at 20-25C. Refrigerated CSPs require 2-8C. Frozen CSPs must be stored at -25 to -10C. Each storage condition affects the beyond-use date assigned to the preparation.

Do I need to monitor differential pressure?

Yes, USP 797 requires maintaining pressure differentials between classified areas. Buffer areas must maintain positive pressure relative to ante-areas, and containment segregated compounding areas for hazardous drugs require negative pressure.

How often must environmental monitoring be documented?

Temperature should be monitored continuously or at minimum daily. Pressure differentials must be continuously monitored between all classified areas. ATEK's continuous monitoring meets these requirements and provides real-time visibility.

Need Help with USP 797 Compliance?

Our team of compliance experts can help you implement monitoring solutions that meet USP 797 requirements. Contact us for a consultation or demo.

Customized compliance assessment for your facility

Validation documentation packages (IQ/OQ/PQ)

Expert support for audits and inspections

Speak with a Compliance Expert

Our team is available to discuss your specific USP 797 compliance requirements.

compliance@atek.io

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Related Regulations

United States

USP 800

USP General Chapter 800 establishes standards for safe handling of hazardous drugs to protect healthcare workers, patients, and the environment. ATEK's environmental monitoring helps facilities maintain the negative pressure containment required for hazardous drug handling.
United States

State Board Pharmacy

State Boards of Pharmacy across all U.S. states establish regulations for medication storage, temperature control, and documentation to ensure medication efficacy and patient safety. These regulations apply to retail pharmacies, hospital pharmacies, compounding pharmacies, and specialty pharmacies. Compliance requires maintaining specific temperature ranges for different medication types, documenting daily temperature checks, retaining records for 3 years, and managing temperature excursions appropriately. ATEK's monitoring platform helps pharmacies meet state board requirements across all 50 states through multi-zone temperature monitoring, automated documentation, NIST-traceable sensors, and comprehensive record retention.
European Union

EU GMP Annex 1

EU GMP Annex 1 (revised 2022) sets the European standard for the manufacture of sterile medicinal products. The revision introduced the Contamination Control Strategy (CCS) as a central requirement and significantly strengthened environmental monitoring obligations. Annex 1 applies to all manufacturers of sterile products sold in the EU, including those manufacturing outside Europe. ATEK's environmental monitoring platform helps pharmaceutical manufacturers meet the stringent monitoring, documentation, and data integrity requirements of Annex 1 through continuous monitoring, automated alerting, and audit-ready reporting.
United States

21 CFR Part 11

FDA 21 CFR Part 11 establishes the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and generally equivalent to paper records and handwritten signatures. ATEK's environmental monitoring platform is designed from the ground up to help organizations achieve and maintain compliance with these critical regulations.
International

GAMP 5

GAMP 5 provides a risk-based framework for validating computerized systems in pharmaceutical and related industries. ATEK's environmental monitoring platform is designed with GAMP 5 principles, providing the validation documentation needed for GxP environments.
Canada

GUI-0050 Annex 11

Health Canada's GUI-0050 Annex 11 provides detailed guidance on the application of Good Manufacturing Practices (GMP) to computerized systems used in pharmaceutical, radiopharmaceutical, biological, and veterinary manufacturing. This guidance was adopted from PIC/S PE-009-15 Annex 11: Computerised Systems, ensuring that Canadian manufacturers meet internationally recognized standards for data integrity, security, and system validation. ATEK's environmental monitoring platform is designed to help organizations achieve and maintain compliance with these comprehensive requirements.

Ready to Simplify USP 797 Compliance?

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