Installation Instructions

Pharmacy Solution Set Matrix
Requirements based on:
• USP 795: Pharmaceutical Compounding – Nonsterile Preparations (Proposed Revision: March 2018) A6V11517837
• USP 797: Pharmaceutical Compounding – Sterile Preparations (Proposed Revision: July 2018) Rev 1 September 2018
• USP 800: Hazardous Drugs – Handling in Healthcare Settings (Proposed Revision: February 2016) Page 9 of 17
USP-NF Chapter 800 Requirement
Evaluation
Engineered Services & Solutions
Building System
Information Management
Service Solutions
Environmental Controls, continued
Containment Secondary Engineering Controls
(C-SEC)
C-PECs must be located within a C-SEC
(buffer area or C-SCA) that meets these
requirements:
 Externally vented through HEPA filters
 Physically separated
 D/P between -0.01 to -0.03 inches wc
Contained Segregated Compounding Area
(C-SCA)
C-PECs may be placed in an unclassified
C-SCA if these requirements are met:
 HEPA-filter-supplied 12 ACPH
 D/P between -0.01 to -0.03 inches wc
relative to adjacent spaces
 Used only for low-risk and medium-risk
HD CSPs
Compounding facilities must be designed
and controlled to provide a well-lit and
comfortable working environment. The
room must be maintained at a temperature
of 20°C or cooler and a humidity below
60% at all times.
 See previous page  See previous page  See previous page  See previous page