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 3 of 17
USP-NF Chapter 795 Requirement
Evaluation
Engineered Services & Solutions
Building System
Information Management
Service Solutions
Controlled Storage Areas
Compounded Nonsterile Preparations
(CNSPs) may be stored under different
storage conditions before they are used. The
following storage conditions typically apply:
 Controlled room temperature: 20 to 25°C
 Refrigerator: 2 to 8°C
 Freezer: -25 to -10°C
To help ensure CNSP quality, personnel must
monitor conditions in the storage areas.
Controlled temperature must be checked at
least daily and the results must be
documented in a temperature log. If a
continuous recording device is in use,
personnel must check at least daily that it is
functional.
CNSPs that are exposed to temperatures that
exceed storage temperature limits shall be
discarded.
 Data integration of storage room,
refrigerators, and freezers into
Desigo CC for monitoring,
documenting, and alarming
 Building automation system collects
trend data and alarm statuses from
integrated equipment.
 Remote notification of alarm conditions
can be provided to pharmacy and
facility staff.
 Facility information services:
o Environmental reporting and
consulting
o Custom report design and creation
for room environment.
Note: If equipment is integrated,
reports can include refrigerator
and freezer temperatures.
o Automatic emailing of reports to
meet daily review requirements
o Data archiving and retrieval
o User training
Standard Operating Procedures
The compounding facility must establish and
follow written standard operating procedures
(SOPs) designed to ensure the quality of the
CNSPs. The SOPs must cover:
 Calibration
 Environmental monitoring
Documentation Standards
All records must be retained for at least three
years or as required by the state laws and
regulations, whichever is longer.
 Desigo CC provides a means of
archiving, managing, processing, and
retrieving business-critical data for a
range of information management and
reporting needs including analysis,
compliance, and management
reporting.
 Automatic linking of SOPs
 Training
 Reporting
 SOP development