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Kastango Consulting Group – Facility Design Services

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Cleanroom Suite Design and Consulting

Through onsite and virtual meetings, a consultant will review the pharmacy program and evaluate the existing physical space and capacity to meet future stated compounding volumes and state and federal compounding regulations. Compounds handled at the client site will be reviewed and the associated risk-level classification verified. The consultant will also examine the architects’ concept layouts, if available, based on recommendations for material flow and storage.

The consultants will participate in the design process and may provide oversight as listed below. This design process will encompass facility requirements as related to compliance with USP 797 and USP 800 as well as USP 795 (as it pertains to USP 800). The consultant’s strategy is to assess the facility for its intended use along with:

• Compounding risk level and general process flow,
• Specific airflow requirements,
• Filter requirements,
• Engineering control requirements,
     • Primary engineering controls (e.g., hoods)
     • Secondary engineering controls (e.g., buffer and ante-room)
• Room pressurization requirements,
• Temperature and humidity requirements,
• Architectural finish requirements.

Design Review and Consulting

A consultant will review the pharmacy program and evaluate the existing physical space and capacity to meet future stated compounding volumes and state and federal compounding regulations. Compounds handled at the client site will be reviewed and the associated risk-level classification verified. The consultant will also examine the architects’ concept layouts, if available, based on recommendations for material flow and storage.

The consultants will participate in the design process and may provide oversight as listed below. This design process will encompass facility requirements as related to compliance with USP 797> and USP 800 as well as USP 795 (as it relates to USP 800). The consultant’s strategy is to assess the facility for its intended use along with:

• Compounding risk level and general process flow,
• Specific airflow requirements,
• Filter requirements,
• Engineering control requirements,
     • Primary engineering controls (e.g., hoods)
     • Secondary engineering controls (e.g., buffer and ante-room)
• Room pressurization requirements,
• Temperature and humidity requirements,
• Architectural finish requirements.

Cleanroom Suite Construction & MEP Document Review

A consultant will perform a review of the construction and MEP documents to verify compliance with the current USP 797 and USP 800 as well as USP 795 (as it relates to USP 800) and provide a review service of construction drawings and documents to ensure the pharmacy will conform to current state and federal sterile compounding standards of practices as well as provide options for materials that KCG has found to perform well in the field.

Post Construction Facility Assessment

Provide a half-day, onsite visit with a two-person team to review and assess the hospital pharmacy and facility design and to perform a gap analysis for compliance with current requirements specified in USP Chapters 797 and 800 as related to the facility only.

This walkthrough will cover facility requirements as related to compliance with USP Chapters 795 (as it pertains to 800), 797, and 800. The consultant’s strategy is to assess the facility for its intended use along with:

• Compounding risk level and general process flow,
• Specific airflow requirements,
• Filter requirements,
• Engineering control requirements,
     • Primary engineering controls (e.g., hoods)
     • Secondary engineering controls (e.g., buffer and ante-room)
• Room pressurization requirements,
• Temperature and humidity requirements,
• Architectural finish requirements.