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 11 of 17
USP-NF Chapter 800 Requirement
Evaluation
Engineered Services & Solutions
Building System
Information Management
Service Solutions
Environmental Monitoring (of Room)
ISO Class 7 buffer or ante-area supplied with
HEPA-filtered air must have:
 Minimum of 30 ACPH
 D/P of -0.01 to -0.03 inches wc between
buffer area and adjacent spaces
 Minimum D/P of 0.02 inches wc between
the ante-area and the buffer area and the
pharmacy
A pressure gauge or velocity meter must be
used to monitor the D/P or airflow between
the buffer and anteroom and between the
anteroom and the general environment. The
results must be logged daily or recorded by a
continuous monitoring device.
Active air sampling (viable) of all ISO-
classified areas must be conducted during
typical operating conditions at least monthly
Total (non-viable) particle counts on ISO
areas must be conducted during operations
every six months
The air quality of the buffer, C-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.
 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
 Provide 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 or negatively
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