Performance Verification of AEC
Downflow Booth
via
Surrogate Air Monitoring with
Lactose Monohydrate
Presented by:
John Kremer of AEC
Hari Floura of Floura LLC
ISPE NJ Chapter Day 2009
Introduction
• AEC has established performance verification testing program for
selected containment systems in their portfolio. improvement.
• AEC has conducted testing to access the airborne particulate
containment performance the AEC Downflow Booth.
• The purpose of the testing was to record the containment
performance of the Downflow Booth when the recommended
operator work practices are followed, and to access the
improvements gained through the use of supplemental engineered
controls.
Third Party Contributors
AEC retained an independent 3rd party expert (SafeBridge Consultants Inc)
to conduct the performance verification testing to ensure the samples and
results were valid.
Floura LLC provided consultation to ensure that the testing was carried out
in accordance with industry standards and the ISPE Good Practice Guide:
Assessing the Particulate Containment Performance of Pharmaceutical
Equipment (President Hari Floura – contributed to the guides development)
Floura LLC is a multi-disciplined consulting company providing services to
the pharmaceutical industry with a core specialty in potent material
handling/containment technology and capabilities for front end facility
design studies and project management. Through their network of
consulting associates, Floura LLC is also able to provide a broad range of
pharmaceutical expertise in areas such as, architectural, process,
commissioning, qualification, validation and rationalization.
Testing Protocol
• Performance verification testing the Downflow Booth was conducted by
surrogate air monitoring with lactose as suggested in the ISPE Good
Practice Guide.
• The testing simulated bulk material transfer through the manual transfer
of 25 kg of lactose from a bulk product drum to a receiving drum.
• One trained operator carried out all the powder handling tasks. The
operators PPE consisted of a Tyvek® disposable suit and several pairs of
nitrile gloves.
Testing Protocol
• The testing was conducted under three operating conditions:
• Downflow Booth alone
• Downflow Booth with drum handler and a ventilated charging collar.
• Downflow Booth with ventilation off
• A total of three process iterations per test condition were conducted. The
duration of each iteration was 20 minutes, with a 15 minute extension to
ensure a sample representative of all dust emitted was collected. The
operator remained in the Downflow Booth during the extension period.
• Only one iteration was conducted with the Downflow Booth off, followed
by a shortened extension period (5 minutes). This was done to limit cross
contamination into the test area.
Testing Protocol
•Air sampling pumps were stopped and the filter cassettes removed
changed at the end of each iteration
Test Equipment
SKC Air Monitoring Pumps Model
224-PCXR4, were operated at a
flow rate of approximately 2.0
liters per minute. These pumps
were calibrated before and after
sampling by an airflow meter,
Mini-Buck Calibrator Model M-5,
calibrated to the National Bureau
of Standards (NBS).
Sample collection device (25 mm, 1.0 µm PTFE
filter in 2-piece blank, conductive cassette)
8”
8”
Air Sampling Locations
Downflow Booth
5’
=
=
8”
8”
8”
Safe Work Zone Limit
=
=
(Plan View)
= Sampling Locations (Consistent with the recommendations of
the ISPE guideline for assessing particulate containment
performance)
Laboratory Analysis
• All air samples were submitted to ESA Laboratories, Inc. (ESA), for
sample analysis for lactose.
• Each sample was number and stored to minimize potential for
degradation
• Field blanks included for every ten air samples collected to assess
potential contamination during sampling, shipping, storage and/or
analysis.
• Blanks handled in the same manner as the other air samples, except that
no air was drawn through the filter cassettes.
• The analytical method for lactose at ESA utilizes High Performance
Liquid Chromatography (HPLC) with Pulsed Amperometric Detection
(PAD).
• The sample was extracted from each PTFE filter utilizing in situ
methodology with a suitable solvent.
• The analytical detection limit reported for lactose was 2 nanograms.
Background Area Air Samples
Testing was conducted over two consecutive days. Two background area
air samples were performed prior to operations each day. Samples
collected both inside and outside the Downflow Booth, at locations used
during the operational testing. One field blank generated for every ten air
samples collected.
Background ranged from <0.01 µg/m3 to <0.05 µg/m3 over the two days.
The one high background reading found inside booth just after bulk
containers were moved in. Field blanks all reported less than 2ng/filter
Testing – No Additional Controls
AEC Downflow Booth testing with no additional engineering controls utilized
Results – No Additional Controls
Total of 21 air samples collected
• Operator exposure assessed by 3 OBZ
samples, one pre iteration. Sample time ranged
between 37 and 39 minutes to complete
(including the 15 minute extension period)
•
•
Range: 0.64 to 1.54 µg/m3
Mean: 1.01 µg/m3
• 18 area air samples – area air samples were
collected at 3 locations within and 3 locations
outside the booth
•
•
•
•
Inside - Range: <0.02 to 0.06 µg/m3
Inside - Mean: 0.03 µg/m3
Outside - Range: <0.02 to 0.05 µg/m3
Outside - Mean: 0.02 µg/m3
Testing – Additional Controls
AEC Downflow Booth testing with additional engineering controls utilized
Additional Controls
A Ventilation Sleeve Containment System and
Drum Handler as Manufactured by EHS solutions
was utilized as a additional engineering control.
This system has the following features:
• Provides high capture velocity around the
perimeter of the collar.
• Liner or funnel of the discharging drum is
positioned below the slotted exhaust plane
of the collar during the discharging process.
Airborne dust contaminates rising up
through the collar are captured in this
exhaust plane, significantly reducing
airborne particle levels.
• Collar supported by portable HEPA filtered
air handling unit, with approximately 425 cfm
airflow.
Results –Booth With Additional Controls
Total of 21 air samples collected
• OBZ air samples for 3 iterations; each iteration
took between 32 and 35 minutes to complete
(including the 15 minute extension period)•
•
Range: <0.03 to 0.04 µg/m3
Mean: 0.03 µg/m3
• 18 area air samples –
•
•
•
•
Inside - Range: <0.03 to <0.03TR µg/m3
Inside - Mean: 0.03 µg/m3
Outside - Range: <0.02 to 0.05 µg/m3
Outside - Mean: 0.03 µg/m3
TR = trace amount detected on sample, although still below the
analytical detection limit for the air volume collected.
No Controls (Downflow Off)
Repeated manual transfer without additional controls with booth turned off.
The purpose of this test was to determine the protection factor offered by the
Downflow booth. Since there was a concern that lactose dust would
contaminate the surfaces in the booth and the testing area, only one iteration
of this test was performed, followed by a limited, 5 minute, extension period.
Results – No Controls (Downflow Off)
Total of 7 air samples collected
• 1 OBZ air samples was collected, for one
iteration. 24 minute sample to complete
(including a 5 minute extension period)
•
Result: 2,250 µg/m3
• 6 area air samples –
•
•
•
•
Inside - Range: 51.6 to 177.0 µg/m3
Inside - Mean: 123.5 µg/m3
Outside - Range: 10.0 to 32.3 µg/m3
Outside - Mean: 20.0 µg/m3
Results – Summary
Test
Condition
Airborne Dust Concentration (lactose) µg/m3 Mean values Operator Breathing Zone (OBZ)
Iteration 1
Iteration 2
Iteration 3
Inside Booth
Max
Outside
Booth
Max
Booth Alone
1.54
0.64
0.86
0.06
0.05
Additional
Controls
<0.03
<0.03
0.04
<0.03
0.05
Booth off
2250
-
-
117
32.2
Results not time weighted – concentrations reported per task duration
Downflow Booth Protection factor = 2000
Conclusions from Testing Results
• Without the Downflow Booth the test results confirm that the airborne dust
concentrations are substantial.
• Results for the 4 background area air samples collected and the 5 field
blanks submitted for analysis, indicate that the sampling and analytical
results obtained in this study are valid.
• The test results clearly demonstrate the effectiveness of the Downflow
Booth to contain and control high airborne concentrations of contaminant.
• While Downflow Booths are generally considered to control operator
exposures to less than 50 µg/m3 of airborne dust, the results of this study
indicate that even greater control can be achieved through supplemental
controls and good operating technique.
Conclusions from Testing Results
• The Downflow Booth alone demonstrated exposure control at 1 µg/m3
for the period of operation. The static area air samples collected inside
and outside were extremely low, with only two samples producing low
but detectable readings.
• The combination of ventilated collar and AEC Downflow Booth
successfully demonstrated exposure control well below 1 µg/m3 for the
period of operation. There was only two samples above the low range
of detection among all the static area air samples collected (0.05
µg/m3).
Conclusions from Testing Results
Material handling in a Downflow Booth can greatly reduce potential operator
exposure to airborne contaminates.
Good operator technique is necessary to control airborne levels.
The use of supplemental engineered controls further decrease airborne
concentrations.
Effectiveness of any engineered control is dependent upon material
properties (electrostatic, dustiness) and process