Facilities and Engineering Control

Learning Objectives

  • Describe air quality requirements in both sterile non-hazardous and hazardous compounding areas, emphasizing the critical role that air quality plays in ensuring the safety and efficacy of compounded sterile preparations (CSPs).

  • Compare various types of primary engineering controls (PECs), including their specific applications in hazardous versus non-hazardous environments, and discuss their importance in maintaining sterile conditions.

  • Summarize essential physical design considerations for sterile compounding facilities, detailing regulatory requirements and best practices to ensure compliance and safety.

Key Terms

  • BSC (Biological Safety Cabinet): A specialized cabinet designed to provide protection from hazardous drug exposure while allowing safe manipulation of these substances.

  • CACI (Compounding Aseptic Containment Isolator): An isolator specifically designed for the safe compounding of hazardous drugs, ensuring that both the product and environment remain uncontaminated.

  • CAI (Compounding Aseptic Isolator): An isolator intended for compounding non-hazardous drugs, focused on maintaining a sterile environment during procedures.

  • C-PEC (Containment Primary Engineering Control): Critical equipment, such as a BSC, that provides a sterile environment for compounding hazardous drugs while minimizing contamination risk.

  • C-SCA (Containment Segregated Compounding Area): A designated space for compounding hazardous drugs that does not meet full cleanroom specifications but still adheres to stringent regulatory standards.

  • CSP (Compounded Sterile Preparation): Any sterile product that has been compounded for patient use, which requires meticulous preparation to ensure safety and sterility.

  • ISO (International Organization for Standardization): The organization that defines standards for air cleanliness and contamination control in areas where CSPs are prepared, including particle limits.

  • LAFW (Laminar Airflow Workbench): A type of PEC that uses a laminar airflow system to filter air and create a sterile working environment for non-hazardous compounding.

  • PPE (Personal Protective Equipment): Essential equipment worn by healthcare personnel to minimize exposure to hazardous substances during compounding activities.

ISO Air Classification

ISO classifications are vital for determining the allowable levels of airborne particles in compounding areas:

  • Class 3: 35.2 particles/m³

  • Class 4: 352 particles/m³

  • Class 5: 3,520 particles/m³

  • Class 6: 35,200 particles/m³

  • Class 7: 352,000 particles/m³

  • Class 8: 3,520,000 particles/m³

These classifications guide the design and operation of PECs and other environmental controls in sterile compounding facilities.

Air Quality Requirements

To ensure safety in compounding areas, certain air quality standards must be met:

  • Primary Engineering Control (PEC): Must maintain ISO Class 5 air quality to protect compounding processes from contamination.

  • Secondary Engineering Control (SEC): Should meet ISO Class 7 standards to support the integrity of sterile preparations during storage and access.

  • Anteroom (negative pressure): Required to be at ISO Class 7 to prevent the escape of hazardous substances into adjacent areas.

  • Anteroom (positive pressure): Maintained at ISO Class 8 to enhance air quality when transitioning from less sterile to more sterile environments.

Air Pressure Parameters

Proper air pressure is paramount for safety and efficacy:

  • Positive Pressure: Necessary during non-hazardous compounding to prevent the infiltration of contaminants into the compounding area and to safeguard CSP integrity.

  • Negative Pressure: Requires stringent controls during hazardous drug handling to protect healthcare workers from exposure and to limit contamination risk.

Air Exchange Requirements

Effective air exchange is crucial in maintaining optimal air quality:

  • ISO Class 7: Requires a minimum of 30 Air Changes per Hour (ACPH) to ensure the removal of airborne particulates.

  • ISO Class 8: Requires ≥20 ACPH to maintain adequate air quality during non-hazardous compounding activities.

  • C-SCA: Must achieve ≥12 ACPH to mitigate contamination risks during hazardous drug compounding.

Types of Compounding Areas

Understanding different compounding environments helps ensure compliance with regulatory standards:

  • Cleanroom Suite: Contains an ISO 7 buffer room equipped with sterile hoods (ISO 5 PECs), ensuring a controlled environment conducive for sterile compounding.

  • Segregated Compounding Area (SCA): Features an ISO 5 hood but operates outside full cleanroom standards; used for less critical compounding activities to ensure quality without elaborate controls.

Primary Engineering Controls (PECs)

Effective PECs are essential for preventing contamination:

  • LAFW: Used for non-hazardous compounding, providing a filtered airflow that helps protect sterile products from airborne contaminants.

  • BSC: Employed for hazardous drug compounding (Class II/III), ensuring containment of harmful substances and protecting personnel and the environment.

  • Restrictions for Classifications: Strict guidelines classify Compound Sterile Preparations (CSPs) into categories that dictate the appropriate compounding environment (Category 1 CSPs in SCA; Category 2/3 CSPs in SEC).

Physical Space Requirements

The design of compounding facilities greatly impacts efficacy and safety:

  • Temperature: Must be maintained at or below 20°C to prevent degradation of products.

  • Humidity: Should not exceed 60% to ensure proper storage conditions for sterile products.

  • Surface Integrity: All surfaces in compounding areas must be smooth, impervious, and nonshedding to facilitate proper cleaning and disinfection practices.

  • Utilities: Clean utility areas must include hands-free sinks for hygienic practices and must be regularly disinfected to prevent contamination.

Material Transfer Guidelines

Proper material handling practices are critical in maintaining sterility:

  • Only items necessary for compounding should enter classified spaces to minimize the risk of contamination.

  • Use isopropyl alcohol for disinfecting materials before introduction into sterile areas to eliminate potential pathogens.

  • Carts and other vehicles for material handling must be nonporous and equipped with cleanable wheels to uphold cleanliness standards throughout the facility.

References

  • United States Pharmacopeia. General chapter, 〈797〉 pharmaceutical compounding—sterile preparations. USP-NF, 2023. In this context, it is essential to follow the latest guidelines and practices outlined by this authoritative source to ensure compliance and safety in pharmaceutical compounding activities.