CETA SERIES: CAG-002-2006
SAN DIEGO, CA
APRIL 17, 2012
PHARMAGARD
COMPOUNDING ISOLATORS
 Provide Class 5 environment
for exposure to a critical site
 Uni-directional Vertical
Laminar Airflow
 Minimize potential for
cross-contamination
 Ensure safety for drug,
patient and pharmacy
PHARMAGARD
PRESSURIZATION
 Work zone is maintained under positive pressure relative to the
ante-chamber
 Contamination can not enter work area from the ante-chamber
 Pharmacist can rest assured they will not contaminate their
compounded materials
PHARMAGARD
PRESSURIZATION
 Work zone is always more positive than interchange to
assure ISO Class 5 cleanliness level
ISOLATORS
 USP referenced CETA as on source of test procedures
 CETA Compounding Isolator Testing Guide (CAG-002-2006)
 Applies to all sterile drug compounding Isolators
CAI and CACI
 Purpose ensure Isolator is designed appropriately for the task
 Test methods are repeatable and accurately reproducible
 Detail guidance for specific field test documentation setting
appropriate acceptance values
TESTING










Filter Integrity
Air Velocity
Pressure Differentials
Leak Test
Glove & Sleeve Leak Test
Routine Monitoring
Cleaning / Decontamination
Particle Counts
Time Factors (transfer purge times)
The rate the background environment requirements based on
the design of the transfer device
WHAT NUAIRE PROVIDES
 Designed test ports that enable particle and other testing
 Purge times for the pass through and main chambers
 Specific acceptance information for velocity, ACHP, pressure, etc.
CETA CAG-002-2006
EIGHT MANDATORY FIELD TESTS
Manufacturer
Certifier
2.01 Airflow Test
Mandatory
Mandatory
2.02 Chamber Pressure Test
Mandatory
Mandatory
2.03 Site Installation Assessment Test
Design Qualifications
Mandatory
2.04 Gauntlet Breach Air Velocity Test
Design Qualifications
Optional
2.05 HEPA Filter Integrity Test
Mandatory
Mandatory
2.06 Particle Containment/Enclosure Leak Test
Mandatory
Mandatory
Design Qualifications
Optional
Mandatory
Mandatory
Design Qualification
Mandatory
Mandatory
Mandatory
2.11 Volatile HD Containment Test
Design Qualifications
Optional
2.12 Hazardous Particle Containment Test
Design Qualification
Optional
2.13 Pass-through Particle Purge Time
Design Qualification
Optional
Procedure
2.07 Recovery Time Determination
2.08 Airflow Smoke Pattern Test
2.09 Preparation Ingress & Egress Test
2.10 Particle Count Test
NUAIRE COMPOUNDING ISOLATOR
TEST RESULTS
 Test Results are published in the Technical Bulletins




NU-PR797 – GTB0150
NU-NR797 – GTB0151
NU-NTE797 – GTB0152
UL Listed
CAG RECOMMENDS POSTING
TEST RESULTS
 These two Test Results need to be posted to aid the
Compounding Isolator Users
 2.07 Recovery Time Determination Test
 2.09 Preparation Ingress / Egress Test
 Design for volatile hazardous drugs, toxic, flammable or
explosive materials
 End user / facility develops own SOP’s for purging and recovery
ISOLATOR PRODUCT LABELS
OTHER POSTINGS
 Information to be completed by testing Technician:




Date tested
Reference report number
Due for retest date (month and year)
Tested by:
1. Name printed
2. Signature
OTHER POSTINGS
 If cabinet does not have manufacturer’s listed information
noted above:
1. Pass / Fail status of the material ingress / egress test
2. Recovery time of the main chamber
3. Indication that the operator has to wait at least the recovery time
before initiating operations after material transfer
4. Ventilation appropriate for use with volatile / non-volatile
hazardous drugs
OTHER POSTINGS
 Information to be pre-printed on label:
 Company Name
 Address
 Phone
GENERAL AIRFLOW BOARD
(GAF)
 NU-PR797 / NR797 / NTE797 – ES Series Standard Series 10 ^
GAF CONTROL BOARD
MULTIPLE BLOWER CONTROLS
 AC on older Series NR / NTE / PR
 EC Impeller Output: Std. on All Isolators (S-10^) NR / NTE / PR
 AC Impeller used in NR for exhausting
GAF
MAIN CONTROL BOARD LAYOUT
AC Blower
POT.
Board AC
Input
Connection
EBM #2
VDC T.P.’s
EMB
T.P.’S
VDC
EMB - ECM
Connector &
POT
EBM-ECM
Connector and
POT 2nd Impeller
AC
Blower
Output
GAF AC/DC MOTOR / IMPELLER
AIRFLOW ADJUSTMENTS
 AC Motor Airflow adjusted via the POT located under heat sink
 DC ECM Impellers utilize another set of potentiometers, on GAF
Board, Std. all Isolators (S-10^)
GAF BOARD
EBM-ECM LAYOUT
GAF BOARD AC OR DC
JUMPER WIRE
Cut Jumper Wire
for AC Motor
PHARMAGARD
BARRIER ISOLATOR
NU-PR797 PharmaGard
Compounding Aseptic Isolator
Positive Pressure Re-circulating
NU-NR797 PharmaGard
Compounding Containment Aseptic Isolator
Negative Pressure Re-circulation
NU-NTE797 PharmaGard
Compounding Containment Aseptic Isolator
Negative Pressure Total Exhaust
NU-PR797
 HEPA filtered vertical unidirectional laminar airflow over
both main and transfer chambers
 90% re-circulation / 10% exhaust
 Main chamber is maintained under
positive pressure relative to
transfer chamber
NU-PR797 AIRFLOW
PHARMAGARD “NU-PR”
CONTROL BOX
2.01 DOWNFLOW VELOCITY PROFILE
(APPLICABLE ON ALL UNITS)
A. Recommended Instruments: TSI 8355 Thermoanemometer
B. Procedure: Supply filter efflux is measured on a grid, in a
horizontal plane 6 inches (152mm) below the supply filter
diffuser. No reading should be taken closer than 6 inches
(152mm) from the inside perimeter
C. Test Data – Inches (mm)
400
6
(152)
11.81
(300)
17.62
(448)
23.43
(595)
29.25
(743)
600
6
(152)
11.91
(303)
17.82
(453)
23.73
(663)
29.64
(753)
6
(152)
10
(254)
14
(356)
35.55
(903)
41.46
(1053)
47.37
(1203)
53.25
(1353)
2.01 DOWNFLOW VELOCITY PROFILE
(APPLICABLE ON ALL UNITS)
Number of Readings
Average Velocity
ft/min. (m/s)
D. Acceptance Criteria:
1. Average downflow velocity > 35 fpm (.18 m/s)
2. Individual readings must be within +20 percent or +16 fpm of the
average downflow velocity, whichever is greater
to
fpm ( to m/s).
E. Meets Acceptance Criteria: Yes
No
2.02 ISOLATOR PRESSURE
(CAG-002)
A. Instrument: Minihelic gauges on isolator
B. Procedure: Review minihelic gauges and confirm that workzone
pressure is greater than 0.15” w.g.
B 1:
 Fully open outer pass-through door - Document any change to pressure.
 Confirm that the pressure does not change from positive to negative or
from negative to positive.
 Close outer pass-through door - Document any change to the pressure.
B 2:
 Using Compounding Isolator glove fully open inner door - Document
any change to the pressure.
 Confirm that the main chamber pressure does not change from positive
to negative or from negative to positive.
 Close inner door - Determine if pressure level returns to original levels.
2.02 ISOLATOR PRESSURE
(CAG-002)
B 3a:
 Record pressure level of Compounding Aseptic Isolator main chamber
with outer & inner pass-through doors closed & Isolator gloves /
gaunlets extended into Isolator.
 Insert hands into gloves and pull back from Isolator to simulate
operator hand removal. An example of a reasonable pull back time is
no greater than 3 seconds from fully extended to fully extracted
(gloves at a point even with the view panel).
 Determine the change in pressure and verify that the pressure does not
change from positive to negative.
B 3b:
 Record pressure level of Compounding Aseptic Containment Isolator
main chamber with outer and inner pass-through doors closed and
Isolator gloves / gauntlets extended outside the Isolator.
 Insert hands into gloves and push into main chamber to simulate
operator hand insertion.
 Determine the change in pressure and verify that the pressure does not
change from negative to positive.
2.02 ISOLATOR PRESSURE
(CAG-002)
C. Acceptance Criteria:
Isolator Pressure Requirements
Actual
Workzone:
>0.15” (3.81mm) w.g.______
Interchange
>0.10” (2.54mm) w.g.______
Difference between
>0.05” (1.27mm) w.g.______
Workzone and Interchange
The pressure shall not change from positive to negative during
any manipulations.
D. Meets Acceptance Criteria: Yes___ No___
2.03 FIELD TEST METHOD
 Site Installation Assessment
 Placement and general conditions or interfaces to
building systems
 Review that remote exhaust airflow or pressure alarm
set-points are working
2.05 SUPPLY HEPA FILTER,
HOUSING AND FRAME LEAK TEST
A. Instruments:
 Aerosol Photometer ATI 2H or equivalent
 PAO Aerosol Generator ATI TDA – 4B or equivalent
B. Procedure:
1. Open front hinged window exposing workzone interior. Remove
supply HEPA diffusers. PAO aerosol is introduced upstream of the
supply HEPA filters by placing supply tube under work surface.
The HEPA filters and periphery are scanned by passing the
photometer probe across the filter, using slightly overlapping
strokes. Scanning shall be done at the transverse rate of not more
than 2 in. /sec. (51mm/sec).
2.05 SUPPLY HEPA FILTER,
HOUSING AND FRAME LEAK TEST
C. Acceptance Criteria:
1. When scanning, a leakage from any point shall not exceed
0.01% of the upstream concentration.
D. Meets Acceptance Criteria: Yes___ No___
SUPPLY HEPA FILTER
INTEGRITY TESTING
(REF: CETA CAG-002, 2.05)
Purpose: This test determines the integrity of all HEPA filters,
filter housings, and filter mounting frames to the IESTRP-CC034. The Isolator shall be set at operational
airflows for this test.
 Instrument:
 Aerosol Photometer ATI 2H or equivalent
 PAO Aerosol Generator ATI TDA – 4B or equivalent
SUPPLY HEPA FILTER
INTEGRITY TESTING
(REF: CETA CAG-002, 2.05)
Procedure:
1.
2.
3.
4.
Open front hinged window exposing workzone interior.
Remove supply HEPA diffusers.
Turn on Isolator blower
Polyalphaolefin (PAO) aerosol is introduced upstream of the HEPA
filter by placing supply tube in the rear center of the workzone over
the intake slots.
5. Sample the upstream challenge using the port provided to verify the
challenge requirement of 10 to 90 micrograms per liter is supplied
and set the photometer to 100%.
6. The HEPA filter and periphery are scanned by passing the
photometer probe across the filter, using slightly overlapping
strokes. Scanning shall be done at the transverse rate of not more
than 2 in./sec. (51 mm/sec).
SUPPLY HEPA FILTER
INTEGRITY TESTING
(REF: CETA CAG-002, 2.05)
Acceptance Criteria:
When scanning, a leakage from any point shall not exceed 0.01%
of the upstream concentration. (Reference GTB0150)
PHARMAGARD
2.06 ENCLOSURE INTEGRITY TEST
A. Instrument: Met One Laser Particle Counter
B. Procedure:
Verify the background count in the testing area is at least 100,00 ppcf.
If the count is too low elevate the background levels using an aerosol
generator. The enclosure integrity test is performed using a particle
counter to measure particle counts within the Isolator workzone and
transfer chamber in specific locations, i.e. window seal, glove port,
sleeves and gloves. The particle count process would be to connect the
input tubing to the test port provided on the Isolator both inside with
several feet of tubing / sampling cone and outside.
2.06 ENCLOSURE INTEGRITY TEST
B. Procedure Continued:
Turn on Isolator and let warm up for several minutes. Turn on particle
counter and flush out sample tubing line to remove latent particles. Set
the particle counter to measure 0.5 micron or larger at 1 CFM
sampling rate. Scan all areas as described below in 1-minute intervals.
• 1-inch (51mm) from entire perimeter of hinged window gasket area
• 1-inch (51mm) from perimeter of glove ports, sleeves and gloves
• 1-inch (51mm) from internal interchange door perimeter seal
Note: If during the scanning process, the 1-minute interval ends,
restart the 1-minute interval and record both values as
necessary.
2.08 AIRFLOW SMOKE PATTERNS
CAG-002
A. Instrument: Smoke Source
B. Procedure:
1. A smoke source shall be passed from one end of the cabinet to the
other, along the centerline of the work surface, at a height of 4 in.
(102mm) above the top of the glove ports.
2. Pass the smoke along the work area beginning 1 in. (2.5cm) from all
main chamber walls and view screens at a height of 4 in. (102mm)
above the top of the glove ports.
3. Pass smoke over gloves, gauntlets, IV bars, interior lights, or other
extruding features that may be installed within the main chamber.
2.08 AIRFLOW SMOKE PATTERNS
CAG-002
C. Acceptance Criteria:
1. The smoke inside the cabinet shall show smooth downward flow
with no dead spots or reflux.
D. Meets Acceptance Criteria: Yes
No
2.09 PRODUCT
INGRESS & EGRESS TEST
Purpose: This test is performed to assure the Isolator workzone
can maintain and ISO 14644-1 Class 5 at 0.5 micron
environment during material transfers with not wait or
purge time during the transfer process when used outside
an ISO Class 7 clean room as mentioned in the USP 797
requirements.
Instrument:
 Met On Laser Particle Counter Model A2408
 Aerosol generator or smoke tubes
 Transfer tray or other compounding materials
2.09 PRODUCT
INGRESS & EGRESS TEST
Procedure:
1. Verify the background count in the testing room is at least
100,000 ppcf (ppcf) (3,532,000 particles per cubic meter (ppcm)).
2. If the count is too low, elevate the background
3. Place the particle counter isokinetic probe in the Compounding
Isolator workzone 8 inches above the worksurface, and 2 inches
outside the normally used path. Probe placement should be so
that the operator’s arms will not pass directly over the probe
when removing material from the pass-through.
4. Verify the particle counts meet ISO Class 5 levels before
beginning the test cycle.
5. Set the particle counter for a 1-minute count with no more than a
one second hold time.
6. Open the outside pass-through door.
2.09 PRODUCT
INGRESS & EGRESS TEST
Procedure:
7. Place a transfer tray into the pass-through and close the outer
door (no wait or purge time required).
8. Open the interior pass-through door and move the transfer tray
from the pass-through to the work area.
9. Close the inside pass-through door.
10. Document the particle counts during the transfer process and for
a period of 1-minute after the transfer.
Acceptance Criteria:
No particle count reading during the 1-minute interval should
exceed 100 ppcf.
2.09 PRODUCT
INGRESS & EGRESS TEST
2.10 CLEANLINESS
CLASSIFICATION TEST - WORKZONE
A. Instrument: Met One Laser Particle Counter
B. Procedure:
1. The Isolator cleanliness classification test is performed using a
particle counter to measure particle counts within the Isolator
workzone. The particle count process would be to connect the input
tubing to the test port provided on the Isolator both inside with
several feet of tubing / sampling cone and outside. Turn on Isolator
and let warm up for several minutes. Turn on particle counter and
flush out sample tubing line to remove latent particles. Set the
particle counter to measure 0.5 micron or larger at 1 CFM
sampling rate.
Take 5 test points in 1-minute intervals on a grid; in a horizontal
plane as measured by the centerpoint of the glove ports. The grid
location is designated as the workzone centerpoint and each corner
measured 6-inches (152mm) from the inside perimeter.
2.10 CLEANLINESS
CLASSIFICATION TEST - WORKZONE
B. Procedure Continued:
2. Position particle counter in the center of the worktray.
Manipulate gloves around the particle counter as to disturb
the air for 60 seconds while the particle counter is reading.
C. Test Data:
1. Particle counts for each test point.
Left Rear
Left Front
2. Center
Center
Right Rear
Right Front
D. Acceptance Criteria:
No particle count during the 1-minute interval should exceed
100 parts per cubic foot.
E. Meets Acceptance Criteria: Yes
No
2.10 CLEANLINESS
CLASSIFICATION TEST –
INTERCHANGE CHAMBER
A. Instrument: Met One Laser Particle Counter
B. Procedure:
1. The Isolator cleanliness classification test is performed using a
particle counter to measure particle counts within the Isolator
interchange. The particle count process would be to connect the
input tubing to the test port provided on the Isolator both inside
with several feet of tubing / sampling cone and outside. Turn on
Isolator and let warm up for several minutes. Turn on particle
counter and flush out sample tubing line to remove latent particles.
Set the particle counter to measure 0.5 micron or larger at 1 CFM
sampling rate.
Take 1 test point for 1-minute on a grid in a horizontal plane as
measured by the centerpoint of the glove ports. The grid location is
designated as the workzone centerpoint.
2.10 CLEANLINESS
CLASSIFICATION TEST –
INTERCHANGE CHAMBER
C. Test Data:
1. Particle counts for:
Center
D. Acceptance Criteria:
No particle count during the 1-minute interval should exceed
100 parts per cubic foot.
E. Meets Acceptance Criteria: Yes
No
NU-NTE797
 HEPA filtered vertical unidirectional laminar
airflow over both main and transfer chambers
 100% exhaust
 Main chamber is maintained under
less negative pressure relative to
transfer chamber
PHARMAGARD “NU-NTE”
AIRFLOW
PHARMAGARD “NTE797”
EXHAUST PACKAGE
 NU-NTE797 Isolator with motorized caster base and
waste disposal 89.5 – 99.5 (glove ports 43”– 53”)
 Exhaust Air Flow Alarm is standard
 Negative Pressure monitor is standard
 Optional Manual Gas-Tight Damper: NU-940-010
 10” Diameter Flex Duct to fit 10” diameter collar on
the isolator: NU-940-004
 Exhaust Requirements:
 4’ NTE 425 CFM @ 2.0” w.g. static
 6’ NTE 550 CFM @ 2.0” w.g. static
PHARMAGARD “NU-NTE”
CONTROL BOX
2.01 DOWNFLOW VELOCITY PROFILE
(APPLICABLE ON ALL UNITS)
A. Recommended Instruments: TSI 8355 Thermoanemometer
B. Procedure: Supply filter efflux is measured on a grid, in a
horizontal plane 6 inches (152mm) below the supply filter
diffuser. No reading should be taken closer than 6 inches
(152mm) from the inside perimeter. Downflow velocities are
taken with the hinged window closed.
C. Test Data – Inches (mm)
400
6
(152)
11.81
(300)
17.62
(448)
23.43
(595)
29.25
(743)
600
6
(152)
11.91
(303)
17.82
(453)
23.73
(663)
29.64
(753)
6
(152)
10
(254)
14
(356)
35.55
(903)
41.46
(1053)
47.37
(1203)
53.25
(1353)
2.01 DOWNFLOW VELOCITY PROFILE
(APPLICABLE ON ALL UNITS)
Number of Readings
Average Velocity
ft/min. (m/s)
D. Acceptance Criteria:
1. Average downflow velocity 35 to 45 fpm (.18 to .23 m/s)
2. Individual readings must be within +20 percent or +16 fpm of the
average downflow velocity, whichever is greater
to
fpm ( to m/s).
E. Meets Acceptance Criteria: Yes
No
2.02 ISOLATOR PRESSURE
(APPLICABLE ON ALL UNITS)
A. Instrument: Minihelic gauges on isolator
B. Procedure: Adjust main chamber pressure
• Start the exhaust system
• Start the blower
• Adjust exhaust system so main chamber pressure is -.25” w.g.
The pressure in the interchange chamber should be maintained at
.05”w.g. lower than the pressure in the main workzone chamber.
This pressure differential can be adjusted by changing the position
of the slide baffle beneath the interchange worktray. If a greater
differential pressure is needed, then loosen the fasteners and slide
the baffle beneath the worktray. If a smaller differential pressure is
needed then slide the baffle out from the worktray. Be sure to tighten
the fasteners before returning to operation of the unit.
2.02 ISOLATOR PRESSURE
(APPLICABLE ON ALL UNITS)
B. Procedure: Continued
B 1:
 Fully open outer pass-through door - Document any change to pressure.
 Confirm that the pressure does not change from positive to negative or
from negative to positive.
 Close outer pass-through door - Document any change to the pressure.
B 2:
 Using Compounding Isolator glove fully open inner door - Document any
change to the pressure.
 Confirm that the main chamber pressure does not change from positive to
negative or from negative to positive.
 Close inner door - Determine if pressure level returns to original levels.
2.02 ISOLATOR PRESSURE
(APPLICABLE ON ALL UNITS)
B. Procedure: Continued
B 3a:
 Record pressure level of Compounding Aseptic Isolator main chamber
with outer & inner pass-through doors closed & Isolator gloves /
gaunlets extended into Isolator.
 Insert hands into gloves and pull back from Isolator to simulate
operator hand removal. An example of a reasonable pull back time
is no greater than 3 seconds from fully extended to fully extracted
(gloves at a point even with the view panel).
 Determine the change in pressure and verify that the pressure does not
change from positive to negative.
2.02 ISOLATOR PRESSURE
(APPLICABLE ON ALL UNITS)
B. Procedure: Continued
B 3b:
 Record pressure level of Compounding Aseptic Containment Isolator
main chamber with outer and inner pass-through doors closed and
Isolator gloves / gauntlets extended outside the Isolator.
 Insert hands into gloves and push into main chamber to simulate
operator hand insertion.
 Determine the change in pressure and verify that the pressure does not
change from negative to positive.
2.02 ISOLATOR PRESSURE
(APPLICABLE ON ALL UNITS)
C. Acceptance Criteria:
Isolator Pressure Requirements
Actual
Workzone
-.25” w.g. +0.05 w.g.______
Interchange at Least -.05 w.g. lower than workzone pressure______
Difference between
>0.05” w.g.______
Workzone and Interchange
The pressure shall not change from positive to negative during any
manipulations.
D. Meets Acceptance Criteria: Yes___ No___
2.03 FIELD TEST METHOD
 Site Installation Assessment
 Placement and general conditions or interfaces to
building systems
 Review that remote exhaust airflow or pressure alarm
set-points are working
 Review the transfer door interlock systems for function
(if installed)
 Review the exhaust canopy or hard connection
performance and use
2.05 HEPA FILTER, HOUSING AND
FRAME LEAK TEST
A. Instruments:
 Aerosol Photometer ATI 2H or equivalent
 PAO Aerosol Generator ATI TDA – 4B or equivalent
B. Procedure:
1. Open front hinged window exposing workzone interior. Remove
supply HEPA diffusers. PAO aerosol is introduced upstream of
the supply HEPA filter by placing supply tube through the
prefilter area. The supply HEPA filter and periphery is scanned
by passing the photometer probe across the filter, using slightly
overlapping strokes. Scanning shall be done at the traverse rate
of not more than 2 in./sec. (51 mm/sec). The exhaust HEPA filter
is checked using the gross leak method. PAO aerosol is
introduced in the rear center of the workzone over the grill.
2.05 HEPA FILTER, HOUSING AND
FRAME LEAK TEST
B. Procedure Continued:
1. The upstream challenge port is located on the left side of the
exhaust filter housing. Sample downstream at a location that will
produce a well mixed aerosol and insert the photometer sampling
probe with rigid extension tubing through hole in exhaust duct.
C. Acceptance Criteria:
1. When scanning, a leakage from any point shall not exceed 0.01%
of the upstream concentration.
2. When gross leak, sustained aerosol penetration shall not exceed
0.005% of the upstream concentration.
D. Meets Acceptance Criteria: Yes
No
NU-NTE797
2.06 ENCLOSURE INTEGRITY TEST
A. Instrument: Met One Laser Particle Counter
B. Procedure:
Verify the background count in the testing area is at least 100,00 ppcf.
If the count is too low elevate the background levels using an aerosol
generator. The enclosure integrity test is performed using a particle
counter to measure particle counts within the Isolator workzone and
transfer chamber in specific locations, i.e. window seal, glove port,
sleeves and gloves. The particle count process would be to connect the
input tubing to the test port provided on the Isolator both inside with
several feet of tubing / sampling cone and outside.
2.06 ENCLOSURE INTEGRITY TEST
B. Procedure Continued:
Turn on Isolator and let warm up for several minutes. Turn on particle
counter and flush out sample tubing line to remove latent particles. Set
the particle counter to measure 0.5 micron or larger at 1 CFM
sampling rate. Scan all areas as described below in 1-minute intervals.
• 2-inches from entire perimeter of hinged window gasket area
• 2-inches from perimeter of glove ports, sleeves and gloves
• 2-inches from internal interchange door perimeter seal
Note: If during the scanning process, the 1-minute interval ends,
restart the 1-minute interval and record both values as
necessary.
2.06 ENCLOSURE INTEGRITY TEST
C. Test Data:
Particle counts for each of the areas as noted in Section B.
1.
2.
3.
D. Acceptance Criteria:
No particle count reading during the 1-minute interval should exceed
100 parts per cubic foot.
E. Meets Acceptance Criteria: Yes
No
2.08 AIRFLOW SMOKE PATTERNS
(APPLICABLE: YES
NO
)
A. Instrument: Smoke Source
B. Procedure:
1. A smoke source shall be passed from one end of the cabinet to the
other, along the centerline of the work surface, at a height of 4 in.
(102mm) above the top of the glove ports.
2. Pass the smoke along the work area beginning 1 in. (2.5cm) from all
main chamber walls and view screens at a height of 4 in. (102mm)
above the top of the glove ports.
3. Pass smoke over gloves, gauntlets, IV bars, interior lights, or other
extruding features that may be installed within the main chamber.
4. For Compounding Aseptic Containment Isolators pay particular
attention to all penetrations, pass-through door, trash disposal tubes
and gloves where turbulence may occur or may indicate significant
penetration of the Compounding Isolator.
2.08 AIRFLOW SMOKE PATTERNS
(APPLICABLE: YES
NO
)
C. Acceptance Criteria:
1. The smoke inside the cabinet shall show smooth downward flow
with not dead spots or reflux.
D. Meets Acceptance Criteria: Yes
No
2.09 PRODUCT
INGRESS & EGRESS TEST
Purpose: This test is performed to assure the Isolator workzone
can maintain and ISO 14644-1 Class 5 at 0.5 micron
environment during material transfers with not wait or
purge time during the transfer process when used outside
an ISO Class 7 clean room as mentioned in the USP 797
requirements.
Instrument:
 Met On Laser Particle Counter Model A2408
 Aerosol generator or smoke tubes
 Transfer tray or other compounding materials
2.09 PRODUCT
INGRESS & EGRESS TEST
Procedure:
1. Verify the background count in the testing room is at least
100,000 ppcf (ppcf) (3,532,000 particles per cubic meter (ppcm)).
2. If the count is too low, elevate the background
3. Place the particle counter isokinetic probe in the Compounding
Isolator workzone 8 inches above the worksurface, and 2 inches
outside the normally used path. Probe placement should be so
that the operator’s arms will not pass directly over the probe
when removing material from the pass-through.
4. Verify the particle counts meet ISO Class 5 levels before
beginning the test cycle.
5. Set the particle counter for a 1-minute count with no more than a
one second hold time.
6. Open the outside pass-through door.
2.09 PRODUCT
INGRESS & EGRESS TEST
Procedure:
7. Place a transfer tray into the pass-through and close the outer
door (no wait or purge time required).
8. Open the interior pass-through door and move the transfer tray
from the pass-through to the work area.
9. Close the inside pass-through door.
10. Document the particle counts during the transfer process and for
a period of 1-minute after the transfer.
Acceptance Criteria:
No particle count reading during the 1-minute interval should
exceed 100 ppcf.
2.09 PRODUCT
INGRESS & EGRESS TEST
Test Data:
Room background count: >100,000 ppcf
Particle Counts (ppcf)
Test 1
Test 2
Test 3
Start
Open/Close Exterior Door
Open Interior Door
Transfer Tray
Close Interior Door
Post Wait Period
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
2.09 PRODUCT
INGRESS & EGRESS TEST
Conclusion:
All 1-minute interval particle counts were well below the 100 ppcf
level meeting and exceeding ISO Class 5 at 0.5 micron. The results
indicate that the Isolator can be used outside an ISO Class 7 clean
room with no wait or purge time required during the material
transfer process.
2.10 CLEANLINESS
CLASSIFICATION TEST - WORKZONE
A. Instrument: Met One Laser Particle Counter
B. Procedure:
1. The Isolator cleanliness classification test is performed using a
particle counter to measure particle counts within the Isolator
workzone. The particle count process would be to connect the input
tubing to the test port provided on the Isolator both inside with
several feet of tubing / sampling cone and outside. Turn on Isolator
and let warm up for several minutes. Turn on particle counter and
flush out sample tubing line to remove latent particles. Set the
particle counter to measure 0.5 micron or larger at 1 CFM
sampling rate.
Take 5 test points in 1-minute intervals on a grid in a horizontal
plane as measured by the centerpoint of the glove ports. The grid
location is designated as the workzone centerpoint and each corner
measured 6-inches (152mm) from the inside perimeter.
2.10 CLEANLINESS
CLASSIFICATION TEST - WORKZONE
B. Procedure Continued:
2. Position particle counter in the center of the worktray.
Manipulate gloves around the particle counter as to disturb
the air for 60 seconds while the particle counter is reading.
C. Test Data:
1. Particle counts for each test point.
Left Rear
Left Front
2. Center
Center
Right Rear
Right Front
D. Acceptance Criteria:
No particle count during the 1-minute interval should exceed
100 parts per cubic foot.
E. Meets Acceptance Criteria: Yes
No
2.10 CLEANLINESS
CLASSIFICATION TEST –
INTERCHANGE CHAMBER
A. Instrument: Met One Laser Particle Counter
B. Procedure:
1. The Isolator cleanliness classification test is performed using a
particle counter to measure particle counts within the Isolator
interchange. The particle count process would be to connect the
input tubing to the test port provided on the Isolator both inside
with several feet of tubing / sampling cone and outside. Turn on
Isolator and let warm up for several minutes. Turn on particle
counter and flush out sample tubing line to remove latent particles.
Set the particle counter to measure 0.5 micron or larger at 1 CFM
sampling rate.
Take 1 test point for 1-minute on a grid in a horizontal plane as
measured by the centerpoint of the glove ports. The grid location is
designated as the workzone centerpoint.
2.10 CLEANLINESS
CLASSIFICATION TEST –
INTERCHANGE CHAMBER
C. Test Data:
1. Particle counts for:
Center
D. Acceptance Criteria:
No particle count during the 1-minute interval should exceed 100 parts
per cubic foot.
E. Meets Acceptance Criteria: Yes
No
NU-NR797
 HEPA filtered vertical unidirectional laminar
airflow over both main and transfer chambers
 80% re-circulation / 20% exhaust
 Main chamber is maintained under
less negative pressure relative to
transfer chamber
PHARMAGARD “NU-NR”
AIRFLOW
PHARMAGARD “NU-NR”
EXHAUST PACKAGE
 NU-NR797 Isolator with motorized castored base and waste
disposal: Height 86.75 – 96.75” w/ Thimble
 Thimble Exhaust Transition: NU-916-797
 Optional Negative Pressure Monitor: Option – 797E80
 6” Diameter Flex Duct to fit 6” diameter collar on the
transition: NU-940-002
 Exhaust Requirements
 4’ NR : 65 CFM @ 0.1” wg static
 6’ NR : 75 CFM @ 0.1” wg static
PHARMAGARD “NU-NR”
CONTROL BOX
2.01 DOWNFLOW VELOCITY PROFILE
(APPLICABLE ON ALL UNITS)
A. Recommended Instruments: TSI 8355 Thermoanemometer
B. Procedure: Supply filter efflux is measured on a grid, in a
horizontal plane 6 inches (152mm) below the supply filter
diffuser with the hinged window closed. No reading should be
taken closer than 6 inches (152mm) from the inside perimeter.
C. Test Data – Inches (mm)
400
6
(152)
11.81
(300)
17.62
(448)
23.43
(595)
29.25
(743)
600
6
(152)
11.91
(303)
17.82
(453)
23.73
(663)
29.64
(753)
6
(152)
10
(254)
14
(356)
35.55
(903)
41.46
(1053)
47.37
(1203)
53.25
(1353)
2.01 DOWNFLOW VELOCITY PROFILE
(APPLICABLE ON ALL UNITS)
Number of Readings
Average Velocity
ft/min. (m/s)
D. Acceptance Criteria:
1. Average downflow velocity 35 to 45 fpm (.18 to .23 m/s)
2. Individual readings must be within +20 percent or +16 fpm of the
average downflow velocity, whichever is greater
to
fpm ( to m/s).
E. Meets Acceptance Criteria: Yes
No
2.02 ISOLATOR PRESSURE
(APPLICABLE ON ALL UNITS)
A. Instrument: Minihelic gauges on isolator
B. Procedure: Adjust exhaust volume via independent motor speed
regulator to achieve -0.1” w.g. on the workzone
minihelic gauge.
B 1:
• Fully open outer pass-through door. Document any change to the pressure.
• Confirm that the pressure does not change from positive to negative or from
negative to positive.
• Close outer pass-through door. Document any change to the pressure.
B 2:
• Using Compounding Isolator glove full open inner door. Document any
change to the pressure.
• Confirm that the main chamber pressure does not change from postive to
negative or from negative to positive.
• Close inner door. Determine if pressure level returns to original levels.
2.02 ISOLATOR PRESSURE
(APPLICABLE ON ALL UNITS)
B. Procedure: Continued
B 3a:
• Insert hands into gloves and pull back from Isolator to simulate operator
hand removal. An example of a reasonable pull back time is no greater than
3 seconds from fully extended to fully extracted (gloves at a point even with
the view panel)
• Determine the change in pressure and verify that the pressure does not
change from positive to negative.
B 3b:
• Insert hands into gloves and push into main chamber to simulate operator
hand insertion.
• Determine the change in pressure and verify that the pressure does not
change from negative to positive.
2.02 ISOLATOR PRESSURE
(APPLICABLE ON ALL UNITS)
C. Acceptance Criteria:
Isolator Pressure Requirements
Actual
Workzone –0.1” w.g. +/- 0.02” w.g.
_________
Interchange < -0.15” w.g.
_________
Difference between > -0.05” w.g.
_________
Workzone and Interchange
The pressure shall not change from positive to negative during any
manipulations.
D. Meets Acceptance Criteria: Yes_____ No_____
2.03 FIELD TEST METHOD
 Site Installation Assessment
 Placement and general conditions or interfaces to
building systems
 Review that remote exhaust airflow or pressure alarm
set-points are working
 Review the transfer door interlock systems for function
(if installed)
 Review the exhaust canopy or hard connection
performance and use
2.05 HEPA FILTER, HOUSING AND
FRAME LEAK TEST
A. Instruments:
 Aerosol Photometer ATI 2H or equivalent
 PAO Aerosol Generator ATI TDA – 4B or equivalent
B. Procedure:
1. Open front hinged window exposing workzone interior. Remove
supply HEPA diffusers. Exhaust filter is accessed on top of the
Isolator. PAO aerosol is introduced upstream of the HEPA filters
by placing supply tube under worksurface. The HEPA filters and
periphery are scanned by passing the photometer probe across
the filter, using slightly overlapping strokes. Scanning shall be
done at the traverse rate of not more than 2 in./sec. (51 mm/sec).
2.05 HEPA FILTER, HOUSING AND
FRAME LEAK TEST
C. Acceptance Criteria:
1. When scanning, a leakage from any point shall not exceed 0.01%
of the upstream concentration.
D. Meets Acceptance Criteria: Yes
No
NU-NR797
2.06 ENCLOSURE INTEGRITY TEST
A. Instrument: Met One Laser Particle Counter
B. Procedure:
Verify the background count in the testing area is at least 100,00 ppcf.
If the count is too low elevate the background levels using an aerosol
generator. The enclosure integrity test is performed using a particle
counter to measure particle counts within the Isolator workzone and
transfer chamber in specific locations, i.e. window seal, glove port,
sleeves and gloves. The particle count process would be to connect the
input tubing to the test port provided on the Isolator both inside with
several feet of tubing / sampling cone and outside.
2.06 ENCLOSURE INTEGRITY TEST
B. Procedure Continued:
Turn on Isolator and let warm up for several minutes. Turn on particle
counter and flush out sample tubing line to remove latent particles. Set
the particle counter to measure 0.5 micron or larger at 1 CFM
sampling rate. Scan all areas as described below in 1-minute intervals.
• 2-inches from entire perimeter of hinged window gasket area
• 2-inches from perimeter of glove ports, sleeves and gloves
• 2-inches from internal interchange door perimeter seal
Note: If during the scanning process, the 1-minute interval ends,
restart the 1-minute interval and record both values as
necessary.
2.06 ENCLOSURE INTEGRITY TEST
C. Test Data:
Particle counts for each of the areas as noted in Section B.
1.
2.
3.
D. Acceptance Criteria:
No particle count reading during the 1-minute interval should exceed
100 parts per cubic foot.
E. Meets Acceptance Criteria: Yes
No
2.08 AIRFLOW SMOKE PATTERNS
CAG-002
A. Instrument: Smoke Source
B. Procedure:
1. A smoke source shall be passed from one end of the cabinet to the
other, along the centerline of the work surface, at a height of 4 in.
(102mm) above the top of the glove ports.
2. Pass the smoke along the work area beginning 1 in. (2.5cm) from all
main chamber walls and view screens at a height of 4 in. (102mm)
above the top of the glove ports.
3. Pass smoke over gloves, gauntlets, IV bars, interior lights, or other
extruding features that may be installed within the main chamber.
4. For Compounding Aseptic Containment Isolators pay particular
attention to all penetrations, pass-through door, trash disposal tubes
and gloves where turbulence may occur or may indicate significant
penetration of the Compounding Isolator.
2.08 AIRFLOW SMOKE PATTERNS
CAG-002
C. Acceptance Criteria:
1. The smoke inside the cabinet shall show smooth downward flow
with no dead spots or reflux.
D. Meets Acceptance Criteria: Yes
No
2.09 PRODUCT
INGRESS & EGRESS TEST
Purpose: This test is performed to assure the Isolator workzone
can maintain and ISO 14644-1 Class 5 at 0.5 micron
environment during material transfers with not wait or
purge time during the transfer process when used outside
an ISO Class 7 clean room as mentioned in the USP 797
requirements.
Instrument:
 Met On Laser Particle Counter Model A2408
 Aerosol generator or smoke tubes
 Transfer tray or other compounding materials
2.09 PRODUCT
INGRESS & EGRESS TEST
Procedure:
1. Verify the background count in the testing room is at least
100,000 ppcf (ppcf) (3,532,000 particles per cubic meter (ppcm)).
2. If the count is too low, elevate the background
3. Place the particle counter isokinetic probe in the Compounding
Isolator workzone 8 inches above the worksurface, and 2 inches
outside the normally used path. Probe placement should be so
that the operator’s arms will not pass directly over the probe
when removing material from the pass-through.
4. Verify the particle counts meet ISO Class 5 levels before
beginning the test cycle.
5. Set the particle counter for a 1-minute count with no more than a
one second hold time.
6. Open the outside pass-through door.
2.09 PRODUCT
INGRESS & EGRESS TEST
Procedure:
7. Place a transfer tray into the pass-through and close the outer
door (no wait or purge time required).
8. Open the interior pass-through door and move the transfer tray
from the pass-through to the work area.
9. Close the inside pass-through door.
10. Document the particle counts during the transfer process and for
a period of 1-minute after the transfer.
Acceptance Criteria:
No particle count reading during the 1-minute interval should
exceed 100 ppcf.
2.09 PRODUCT
INGRESS & EGRESS TEST
Test Data:
Room background count: >100,000 ppcf
Particle Counts (ppcf)
Test 1
Test 2
Test 3
Start
Open/Close Exterior Door
Open Interior Door
Transfer Tray
Close Interior Door
Post Wait Period
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
2.09 PRODUCT
INGRESS & EGRESS TEST
Conclusion:
All 1-minute interval particle counts were well below the 100 ppcf
level meeting and exceeding ISO Class 5 at 0.5 micron. The results
indicate that the Isolator can be used outside an ISO Class 7 clean
room with no wait or purge time required during the material
transfer process.
2.10 CLEANLINESS
CLASSIFICATION TEST - WORKZONE
A. Instrument: Met One Laser Particle Counter
B. Procedure:
1. The Isolator cleanliness classification test is performed using a
particle counter to measure particle counts within the Isolator
workzone. The particle count process would be to connect the input
tubing to the test port provided on the Isolator both inside with
several feet of tubing / sampling cone and outside. Turn on Isolator
and let warm up for several minutes. Turn on particle counter and
flush out sample tubing line to remove latent particles. Set the
particle counter to measure 0.5 micron or larger at 1 CFM
sampling rate.
Take 5 test points in 1-minute intervals on a grid; in a horizontal
plane as measured by the centerpoint of the glove ports. The grid
location is designated as the workzone centerpoint and each corner
measured 6-inches (152mm) from the inside perimeter.
2.10 CLEANLINESS
CLASSIFICATION TEST - WORKZONE
B. Procedure Continued:
2. Position particle counter in the center of the worktray. Manipulate
gloves around the particle counter as to disturb the air for 60
seconds while the particle counter is reading.
C. Test Data:
1. Particle counts for each test point.
Left Rear
Left Front
2. Center
Center
Right Rear
Right Front
D. Acceptance Criteria:
No particle count during the 1-minute interval should exceed
100 parts per cubic foot.
E. Meets Acceptance Criteria: Yes
No
2.10 CLEANLINESS
CLASSIFICATION TEST –
INTERCHANGE CHAMBER
A. Instrument: Met One Laser Particle Counter
B. Procedure:
1. The Isolator cleanliness classification test is performed using a
particle counter to measure particle counts within the Isolator
interchange. The particle count process would be to connect the
input tubing to the test port provided on the Isolator both inside
with several feet of tubing / sampling cone and outside. Turn on
Isolator and let warm up for several minutes. Turn on particle
counter and flush out sample tubing line to remove latent particles.
Set the particle counter to measure 0.5 micron or larger at 1 CFM
sampling rate.
Take 1 test point for 1-minute on a grid in a horizontal plane as
measured by the centerpoint of the glove ports. The grid location is
designated as the workzone centerpoint.
2.10 CLEANLINESS
CLASSIFICATION TEST –
INTERCHANGE CHAMBER
C. Test Data:
1. Particle counts for:
Center
D. Acceptance Criteria:
No particle count during the 1-minute interval should exceed 100 parts
per cubic foot.
E. Meets Acceptance Criteria: Yes
No