Presentation covering the basics of nonviable particle testing in pharmacy iv rooms.

1. Environmental Monitoring:
NONVIABLE AIRBORNE PARTICLE TESTING

2. Nonviable particles may act as transport
vehicles for bacteria and other living
organisms

3. Nonviable sampling differs from viable
particle sampling in that it is intended to
establish the level of air cleanliness, i.e. ISO
Class

4. Remember that ISO standard 14633-1
defines the level of airborne particulate
applicable to ISO Class

5. For purposes of USP <797> cleanrooms are
classified by the 0.5-micron particle size

6. Particle Limits by Area
Class Limit of 0.5-micron
particles/m3 of air
Area
ISO 5 3,520
Primary Engineering Controls
(LAFW, BSC, CAI, CACI)
ISO 7 352,000
Buffer Area and Ante-Area
Opening into a Negative
Pressure Room
ISO 8 3,520,000
Ante-Area opening only into a
Positive Pressure Room

7. It is therefore critical to ensure low nonviable
particle counts by certifying that primary and
secondary engineering controls meet their
ISO classification

8. Nonviable particle testing must be performed in each
ISO classified area, i.e. both Primary Engineering
Controls (LAFWs, BSCs, CAIs, CACIs) and Secondary
Engineering Controls (buffer area/cleanrooms and
ante-areas)

9. Areas must maintain appropriate ISO Class
during dynamic working conditions, i.e.
when people are doing their jobs.

10. According to USP Chapter <797>
Certification procedures such as those
outlined in Certification Guide for
Sterile Compounding Facilities (CAG-
003-2006) shall be performed by a
qualified individual no less than every 6
months and whenever the device or
room is relocated or altered or major
service to the facility is performed.
“

11. Additional testing should occur when:
responding to problems with staff technique
or end products
- OR -
responding to issues with CSPs, observed compounding
personnel work practices, or patient-related infections
where the CSPs may be considered a potential source

12. The Controlled Environment Testing
Association (CETA) details specific procedures
to be used in the cleanroom certification
process in the Certification Guide for Sterile
Compounding Facilities (CAG-003-2006)

13. CETA’s Guide CAG-003-2006 is followed by
most facilities

14. While the CETA guidelines detail specific
procedures to be used in the certification
process, they do not specify documentation
requirements for the certification reports. As
a result reports may vary significantly.

15. However, certification reports should provide
documented proof that the facility’s
engineering controls are performing as
expected to create a safe environment for
compounding sterile products.

16. A good certification report will include test
equipment used, description of each test
conducted along with all data and calculations,
test results with clear pass/fail indication, facility-
specific acceptance criteria, and orientation
drawings.

17. JERRY FAHRNI, PHARM.D.