|
Healthcare
USP 797 - Pharmaceutical
Compounding-Sterile Preparations
AirGas Test is now able to assist
you in meeting the requirements of
USP 797 - Pharmaceutical
Compounding-Sterile Preparations.
General Environmental Monitoring
Requirements for USP 797 include:
Hood Testing Frequency; 6 months
Particle Testing
Frequency; 6 months
ISO
Class 8: 3,520,000 particles >.5um
ISO
Class 7: 352,000 particles >.5um
ISO
Class 5: 3520 particles >.5um
Room Ventilation
Testing Frequency; 6 months
General Air Changes
Guidelines is 20 plus; tested every
6 month
Relative Humidity 35
– 65%
Temperature 62 – 70
degrees F
Differential
Pressures of 0.02” of wc; tested
every 6 months
Monthly testing with
settling plates for bacterial load
AirGas Testing
is offering an audit of your
facilities designed to evaluate the
USP 797 compliance status of your
facility:
-
A
survey on the Environmental
Control Section of USP 797.
Included in the survey is a
walkthrough, particle counts in
the rooms, the hoods and
assistance in understanding and
resolving equipment compliance
issues in USP 797.
-
The self
assessment survey will assist you
with your gap analysis of the
Environmental Control Section of
the USP 797.
If your facility
requires a particle count only,
AirGas Test will take particle
counts for Rooms, Laminar Flow
Cabinets, Biological Safety cabinets
and Barrier Isolators. You will
receive a report documenting the
results.
Get the USP 797
Audit by contacting us at
info@AirGasTest.com or by
calling (866)772-0768.
|
