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 5 of 17
USP-NF Chapter 797 Requirement
Evaluation
Engineered Services & Solutions
Building System
Information Management
Service Solutions
Security
Access of personnel to controlled areas must
be restricted. The PEC must be located in a
controlled-access buffer area.
When designing the facility, hands-free
access doors are preferred.
 Assessment of security and access
control
 Secure access into the controlled area
via:
o Card access
o CCTV
o Digital recording
 Door interlocks
Note: Airlocks and interlocking doors
can be used to facilitate better control
of air balance between a higher-
classified area and an area of lesser air
quality (for example, between the
buffer area and ante-area), or between a
classified area and an unclassified area.
 Hands-free doors
 Intrusion monitoring and alarming
 Door status
 Door access restrictions
 Door interlocks
 Security services