31 Chapter 31: Cleaning and Maintenance of Equipment

Maintaining a clean and well-functioning compounding environment is essential for producing high-quality non-sterile preparations. Effective cleaning and maintenance protocols reduce the risk of contamination, safeguard personnel, and ensure compliance with national and provincial standards. Below is an overview of the cleaning requirements for compounding areas and equipment, proper use of cleaning agents, documentation expectations, and how these practices support overall quality assurance in the pharmacy.

Cleaning and Maintenance of Equipment and Facilities

(Based on NAPRA Model Standards and Guidance Document)

1. Purpose of Cleaning and Maintenance

Proper cleaning and maintenance of facilities and equipment is essential to:

• Maintain the quality and integrity of compounded preparations.
• Minimize the risk of contamination and cross-contamination.
• Ensure a safe and sanitary working environment for compounding personnel.
• Comply with pharmacy regulatory standards and ensure ongoing inspection readiness.

2. Facilities Cleaning Requirements

• Compounding Area:
  • Must be cleaned daily and as needed (e.g., after spills, at end of shifts).
  • Includes work surfaces, walls, floors, shelves, and storage areas.
  • Surfaces must be smooth, non-porous, and easily cleanable.
• Other Pharmacy Areas:
  • Areas near compounding spaces (e.g., staging and storage areas) must also be regularly cleaned to prevent contamination.
• Cleaning Products:
  • Use appropriate cleaning agents that do not leave residues that could interfere with compounded preparations.
  • Disinfectants should be compatible with the surfaces and effective against expected microbial contaminants.
• Special Requirements:
  • If hazardous materials are compounded, additional decontamination procedures are required.

3. Equipment Cleaning and Maintenance Requirements

• General Equipment:
  • Equipment (e.g., balances, mixers, mills, capsule fillers) must be:
    • Cleaned after each use.
    • Calibrated and maintained according to the manufacturer’s recommendations.
    • Inspected regularly to ensure it is functioning properly and does not introduce contamination.
• Specific Guidelines:
  • After each compounding session, clean thoroughly to remove any residues.
  • Dedicated equipment should be used for compounding hazardous materials or cleaning validated between uses if shared.
  • Damaged or worn equipment must be removed from service immediately until repaired or replaced.

4. Documentation Requirements: General Maintenance Log

A General Maintenance Log must be kept to document cleaning and maintenance activities for both equipment and facilities.

5. Key Documentation Rules

• Cleaning and maintenance activities must be logged immediately after completion.
• Logs must be reviewed regularly by a designated supervisor (e.g., Compounding Supervisor or Pharmacy Manager).
• Logs must be retained as part of the pharmacy’s quality assurance program.
• Any deviations (e.g., a failed calibration or a missed cleaning) must have a recorded corrective action.

6. Quality Assurance Connection

• Regular review of cleaning and maintenance documentation helps identify:
  • Trends that could impact product quality (e.g., repeated equipment issues).
  • Training needs if cleaning procedures are not properly followed.
  • Potential risks that must be addressed proactively to maintain compliance.

Cleaning and maintenance are not just routine tasks—they are critical components of a pharmacy’s compounding quality assurance system. By following structured procedures, using appropriate cleaning products, and maintaining accurate records, pharmacies can ensure the safety of compounded products, protect personnel, and meet inspection and regulatory requirements. Consistent monitoring and documentation of these activities also help identify and correct issues early, fostering a proactive culture of safety and regulatory compliance in non-sterile compounding environments.