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 8 of 17
USP 800 Matrix
USP-NF Chapter 800 Requirement
Evaluation
Engineered Services & Solutions
Building System
Information Management
Service Solutions
Environmental Controls
Containment Primary Engineering Controls
(C-PECs)
All sterile and non-sterile hazardous drugs
(HDs) as defined by NIOSH
2
must be
compounded within a C-PEC. The C-PEC
must operate continuously if it is used for
sterile compounding or if it supplies negative
pressure for the area.
Buffer and Cleanroom Areas
3
,
4
C-PECs must be located within a buffer or
cleanroom area with at least ISO Class 7 air
quality.
An ante-area provides access to the buffer
area and must meet at least ISO 7 standards.
The buffer area for HD CSPs must be from
0.01 to 0.03 inches wc less than adjacent
areas (that is, D/P from -0.01 to -0.03 inches
wc), with at least 30 ACPH.
The anteroom which provides entry into a
buffer room must have:
 HEPA-filter-supplied 30 ACPH
 Positive pressure of at least 0.02 inches wc
greater than all adjacent spaces
 ISO Class 7
 Assessment of current environment
o Air cleanliness
o Room construction
o Exhaust system
o Supply air
o Cooling system
o Temperature and humidity control
o D/P control and monitoring
 Pharmacy assessment report
 Design, installation, and
commissioning of (enhanced) room
controls for the buffer and anteroom
areas to achieve desired airborne
particle count, ACPH, D/P,
temperature, and humidity levels
 Custom DXR Lab application for
C-PEC
 DXR Lab application that can interlock
with C-PEC fan and provide shutdown
when flow or pressure is compromised
 Particle counter integration when
installed for continuous monitoring
 RCM II for monitoring D/P and for
local display of D/P, temperature,
humidity, ACPH, and particle counts
(if available)
 Fire alarm system per local codes
 Backup to EES (Essential Electrical
System) power per NFPA 99
 RCM II provides local indication of
D/P, temperature, humidity, ACPH,
and particle counts (if available).
 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
(temperature, humidity, pressure,
ACPH, and alarm statuses).
 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 Cleanroom testing and
certification
o Cabinet testing and certification
o Calibration
o Training
o Automation service offering for
CMS compliance
 Facility Information Services
o Environmental reporting and
consulting
o Custom report design and creation
(temperature, humidity, ACPH,
positive and negative
pressurization)
Note: If equipment is integrated,
reports can include refrigerator
and freezer temperatures and
particle counter readings.
o Data archiving and retrieval
o User training
2
National Institute for Occupational Safety and Health
3
If used to prepare only Category 1 CSPs, the C-PEC may be located in a containment segregated compounding area (C-SCA).
4
If ISO class 5 is achieved using an isolator, the isolator can be located in an ISO Class 8 area and can be used to prepare Category 2 CSPs.