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 12 of 17
USP-NF Chapter 800 Requirement
Evaluation
Engineered Services & Solutions
Building System
Information Management
Service Solutions
Controlled Storage Areas
CSPs may be stored under different storage
conditions before they are used. The
following storage conditions apply:
 Controlled room temperature: 20 to 25°C
 Refrigerator: 2 to 8°C
 Freezer: -25 to -10°C
To help ensure CSP 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.
CSPs that are exposed to temperatures that
exceed storage temperature limits shall be
discarded.
HDs must be stored in a negative-pressure
room with at least 12 ACPH. HDs used in
sterile compounding may be stored in the
negative-pressure buffer room.
Refrigerated HDs must be stored in a
dedicated refrigerator in a negative-pressure
area with at least 12 ACPH.
 Assessment of storage area
 Data integration of refrigerators and
freezers into Desigo CC for monitoring,
documenting, and alarming
 DXR Lab application of HD storage
room
 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
(temperature, humidity, ACPH,
negative pressurized)
Note: If equipment is integrated,
reports can include refrigerator
and freezer temperatures and
particle counter readings.
o Automatic emailing of reports to
meet daily review requirements
o Data archiving and retrieval
o User training