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 2 of 17
USP 795 Matrix
USP-NF Chapter 795 Requirement
Evaluation
Engineered Services & Solutions
Building System
Information Management
Service Solutions
Environmental Controls
Any activity that may result in airborne
contamination (powder) must be performed in
a containment ventilated enclosure (CVE).
Compounding facilities must be designed
and controlled to provide a well-lit and
comfortable working environment. The room
temperature and humidity must be
maintained as required to ensure operator
comfort.
 Assessment of current environment
o Room construction
o Exhaust system
o Supply air
o Cooling system
o Temperature and humidity control
 Design, installation, and
commissioning of room controls for the
compounding area to achieve desired
temperature and humidity levels
 RCM II for local monitoring of
temperature and humidity
 Fire alarm system per local codes
 Backup to EES (Essential Electrical
System) power per NFPA 99
 RCM II provides local indication of
temperature and humidity.
 The Desigo CC workstation serves as
the primary interface into the building
automation system for real-time
monitoring, troubleshooting, control of
building systems, alarm management,
and collection of trend data.
 The RENO (Remote Notification
option for Desigo CC) allows
notification of alarm, status, and system
event information for all points
integrated into the system.
 Desigo CC provides for the archiving
and reporting of data needed to
demonstrate compliance with
applicable regulations.
 Compliance services:
o Cabinet testing and certification
o Calibration
o Training
o Automation service offering for
CMS compliance
 Facility information service:
o Environmental reporting and
consulting
o Custom report design and
creation.
Note: If equipment is integrated,
reports can include the room
environment and temperature
readings for the refrigerator and
freezer.
o Data archiving and retrieval
o User training
Security
Access to the compounding area must be
controlled.
 Assessment of security and access
control
 Secure access into the controlled area
via:
o Card access
o CCTV
o Digital recording
 Intrusion monitoring and alarming
 Door status
 Door access restrictions

Door interlocks
 Security services