What is a Clean Room in a Pharmacy?

In pharmaceutical settings, a clean room is a meticulously controlled environment designed to minimize contamination during the preparation, compounding, and handling of sterile medications. These specialized spaces are vital for ensuring medication safety and efficacy, particularly for high-risk preparations like IV therapies, chemotherapy drugs, and ophthalmic solutions.

• Prevents microbial contamination of sterile products
• Eliminates particulate matter in injectable medications
• Reduces cross-contamination risks for hazardous drugs (e.g., antineoplastics)

Required by:

• USP <797> (Pharmaceutical Compounding - Sterile Preparations)
• USP <800> (Hazardous Drugs)
• FDA cGMP guidelines

Mandatory for:

• Hospital pharmacies
• Compounding facilities
• Oncology preparation centers

• Sterile IV admixture preparation
• Chemotherapy drug compounding
• Ophthalmologic solution preparation
• Total parenteral nutrition (TPN) compounding

• Laminar airflow workbenches (LAFW)
• Biological safety cabinets (BSC)
• Compounding aseptic isolators (CAI)

• HEPA filtration (99.97% efficiency for 0.3µm particles)
• Positive/negative pressure zones (for hazardous vs. non-hazardous drugs)
• Continuous air exchanges (≥30 ACH in buffer areas)

• Non-porous, seamless surfaces (epoxy resin floors, fiberglass-reinforced walls)
• Coved corners for easy cleaning
• Interlocked pass-through chambers for material transfer

• Comprehensive aseptic technique training
• Proper gowning sequence (shoe covers → hair cover → mask → sterile gloves)
• Annual media-fill test competency validation

• Daily particle counts
• Weekly surface microbial sampling
• Monthly air viability testing

• Disinfectant rotation (e.g., sporicidal agents weekly)
• Strict documentation of cleaning logs
• Validation of cleaning effectiveness

• ► Robotic Compounding Systems - Reduce human intervention in sterile preparation
• ► Real-time Monitoring - Continuous particle and microbial detection
• ► Modular Designs - Flexible clean room configurations for space-limited pharmacies

• ❗ Pressure Differential Maintenance - Critical for preventing contamination
• ❗ Personnel Training Gaps - Leading cause of sterility failures
• ❗ Documentation Errors - Common FDA 483 observation

Pharmacy clean rooms are non-negotiable for safe medication preparation. As regulatory standards evolve (particularly USP <797> 2023 revisions), facilities must invest in proper design, ongoing monitoring, and staff training to ensure patient safety and compliance.