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 4 of 17
USP 797 Matrix
USP-NF Chapter 797 Requirement
Evaluation
Engineered Services & Solutions
Building System
Information Management
Service Solutions
Environmental Controls
Primary Engineering Controls (PECs)
All Compounded Sterile Preparations (CSPs)
must be prepared in an ISO Class 5
environment. Class 5 standards are achieved
through the use of a PEC or an isolator.
Buffer and Cleanroom Areas
1
PECs need to 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 8
standards. Buffer area for CSPs must be at
least 0.02 inches water column (wc) greater
than adjacent spaces.
The anteroom which
provides entry into a buffer room must have:
 HEPA-filter-supplied 20 ACPH
 Positive pressure of 0.02 inches wc relative
to all adjacent unclassified spaces
 ISO Class 8 for CSPs
Workbenches and Barrier Isolators
PECs generally include laminar airflow
workbenches, biological safety cabinets, and
isolators. 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.
 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 Differential pressure (D/P) control
and monitoring
 Design, installation, and
commissioning of (enhanced) room
controls for the buffer and anteroom
areas to achieve the desired airborne
particle count, air changes per hour
(ACPH), D/P, temperature, and
humidity levels
 Custom DXR Lab application for PEC
 DXR Lab application that can interlock
with 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.
 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 Clean room 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,
and positive 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
1
If used to prepare only Category 1 CSPs, the PEC may be located in an unclassified area, without a buffer or ante-area. The area must be a segregated compounding area (SCA).