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 6 of 17
USP-NF Chapter 797 Requirement
Evaluation
Engineered Services & Solutions
Building System
Information Management
Service Solutions
Environmental Monitoring (of Room)
An ISO Class 7 buffer or ante-area supplied
with HEPA-filtered air must have a minimum
of 30 ACPH.
A minimum D/P of 0.02 inches wc is required
between ISO classifications and the buffer
area and the pharmacy. A continuous
monitoring system must be used to monitor
the D/P between the buffer and the anteroom
and between the anteroom and the general
environment. The results must be recorded
and reviewed daily during operations.
Active air sampling (viable) of all ISO-
classified areas must be conducted during
typical operating conditions every 6 months.
Total (non-viable) particle counts on ISO
areas must be conducted during operations
every six months
The air quality of the buffer, PEC, and
anteroom area must be evaluated by a
qualified operator for conformance to ISO
Class requirements, as appropriate, at least
every six months and when renovations
occur. All certification and recertification
records must be reviewed by supervising
personnel or other designated employees to
ensure that the environments comply with
proper standards. Areas must be certified
using procedures in the current Controlled
Environment Testing Association (CETA)
certification guide for Sterile Compounding
Facilities or equivalent guideline.
 Assessment of environment
 Design, installation, and
commissioning of (enhanced) room
controls for the buffer and anteroom
areas to achieve the desired ACPH,
D/P, temperature, and humidity levels
 DXR Lab application for maintaining
room environment
 Integration of non-viable particle
counter (if installed)
 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).
 RCM II can be utilized for local
indication of D/P, ACPH, temperature,
and humidity.
 Facility information services:
o Environmental reporting and
consulting
o Custom report design and creation
(temperature, humidity, ACPH,
positively pressurized.)
Note: If equipment is integrated,
reports can include refrigerator
and freezer temperatures and
particle counter readings.
o Data archiving and retrieval
o User training
 Cleanroom testing and certification
(may include the following tests):
o Air volume and velocity
o HEPA filter integrity test
o Pressurization (includes room air
exchange rates)
o Airborne particle count
o Smoke testing
o Recovery test
o Temperature and humidity