PROTOCOL 17-0033
Aerosol Performance the Feellife
April 17, 2017 Dave Piper, PE Piper Medical Products 1053 Village Ln Chico, CA 95926 Tel 530-588-6119 [email protected] www.PiperMedical.com
PIPER MEDICAL Protocol 17-0033
PROTOCOL: Aerosol Performance the Feellife Air Force Portable Mesh Nebulizer
Prepared By: S. David Piper, PE Date: 03/28/2017
Approved By: S. David Piper, PE Date: 03/28/2017
Tested By: Rocky Jewell,
Cora Piper
Date: 03/29/2017-04/14/2017
Reported By: S. David Piper, PE Date: 04/17/2017
Approved By: S. David Piper, PE Date: 04/17/2017
1.0 Objective
1.1 To measure the aerosol performance of the Feellife Air Force Port able Mesh Nebulizer while aerosolizing albuterol sulfate (2.5 mg/3 ml).
2.0 Reference
2.1 DRAFT VERSION “REVIEWER GUIDANCE FOR NEBULIZER, METERED DOSE INHALERS, SPACERS AND ACTUATORS” October 1993.
2.2 DRAFT VERSION “REVIEWER GUIDANCE FOR PREMARKET NOTIFICATION SUBMISSIONS” November 1993.
2.3 GOOD LABORATORY PRACTICE REGULATIONS, USFDA (21 CFR PART 58)
2.4 PIPER MEDICAL SOP-E-126 – SPECTOPHOTOMETER OPERATION
2.5 PIPER MEDICAL SOP-E-129 – CASCADE IMPACTOR OPERATION
2.6 PIPER MEDICAL SOP-E-125 – NEBULIZER TEST METHODS
2.7 PIPER MEDICAL SOP-E-128 – MICROBALANCE OPERATION
2.8 PIPER MEDICAL SOP-E-130 – AEROSOL AND AIRBORNE PARTICULATE FILTER TESTING AND OPERATION
April 17, 2017 Piper Medical Protocol 17-0033 Page 1 of 9
PIPER MEDICAL Protocol 17-0033
PROTOCOL: Aerosol Performance the FeeLlife Air Force Portable Mesh Nebulizer
3.0 Acceptance Criteria
3.1 All equipment and laboratory processes used and specified will meet their pre-determined operation and calibration requirements before and after testing. All testing shall be performed per GLP.
3.2 The mass of medication accounted for at the end and beginning of each test shall be the same within 15%.
4.0 Equipment List
4.1 Feellife Air Force Portable Mesh Nebulizer, three samples - Piper sample ID 170323-4, 170323-5, and 170323-6.
4.2 0-60 psig Pressure Gauge (E-019)
4.3 Gilmont glass float type Rotameter (E-015)
4.4 Gilmont glass float type Rotameter (E-003)
4.5 7-stage Cascade Impactor, w/ membrane filter for 8th stage (E-032)
4.6 Spectrophotometer (E-113)
4.7 Vacuum pump (in-house)
4.8 Compressed gas source (in-house)
4.9 Denver Instruments Electronic Balance XP-300 (E-116)
4.10 Mettler Microbalance AE200 (E-067)
4.11 Cahn Microbalance C-31 (E-031)
4.12 Extech Humidity Temperature Meter (E-100)
4.13 Membrane filters – Cellulose Ester, 47 mm diameter
4.14 Large Reservoir Pipette (E-033)
4.15 Membrane filters – Cellulose Ester, 47 mm diameter
4.16 Medication – albuterol sulfate (2.5 mg/3 ml)
4.17 Data Acquisition System
April 17, 2017 Piper Medical Protocol 17-0033 Page 2 of 9
PIPER MEDICAL Protocol 17-0033
PROTOCOL: Aerosol Performance the FeeLlife Air Force Portable Mesh Nebulizer
Testing Procedure
5.1 Sample Preparation 5.1.1 Three samples of the Feellife Air Force Portable Mesh Nebulizer have
been provided for testing. Each sample device will be tested once with albuterol sulfate. The Feellife Air Force will be tested after being charged for 24 hours.
5.2 Aerosol Testing. 5.2.1 The samples shall be tested with albuterol sulfate (2.5 mg/3 ml). There
shall be one aerosol test for each sample, for a total of three aerosol tests.
5.2.2 The nebulizer shall be operated as described in product insert. 5.2.3 Sampling with the cascade impactor shall begin immediately prior to
turning on nebulizer. The cascade impactor shall be equipped with a USP throat and run at a continuous flow of 28 l/min. Sampling with the cascade impactor shall continue for the entire treatment. Treatment time will be measured and treatment will be determined to have ceased when visual indication of aerosol production has ceased for a period of at least 1 second.
5.2.4 Upon completion of simulated nebulizer treatment, turn off nebulizer. Disassemble cascade impactor and place specimen plates and membrane filter for each stage of the cascade impactor into different specimen containers.
5.2.5 Place 10 mL of distilled water into each specimen container. Obtain concentration readings using spectrophotometer for each cascade impactor stage. Calculate the mass of drug deposited on each cascade impactor stage.
5.2.6 Enter cascade impactor data into cascade impactor spread sheet, plot accumulated mass percents on log-log paper. Determine expulsion, MMAD, GSD, respirable dose (0.5 to 5 microns) using standard cascade impactor data analysis techniques (SOP-e-129).
5.2.7 Tabulate data.
April 17, 2017 Piper Medical Protocol 17-0033 Page 3 of 9
PIPER MEDICAL Protocol 17-0033
PROTOCOL: Aerosol Performance the FeeLlife Air Force Portable Mesh Nebulizer
Figure 1 showing the test set up for sampling aerosol from the Air Force
April 17, 2017 Piper Medical Protocol 17-0033 Page 4 of 9
PIPER MEDICAL Protocol 17-0033
PROTOCOL: Aerosol Performance the Feellife Air Force Portable Mesh Nebulizer
RESULTS
Aerosol Performance Testing with Albuterol Sulfate
Particle Size (MMAD)
Geometric Standard Deviation
Total Dose
Total Respirable Dose (0.5-5
um)
Coarse Particle
Dose (>4.7 um)
Fine Particle
Dose (<4.7 um)
Ultra-Fine Particle
Dose (<1.0 um)
(µm)
Feellife Air Force
1 2.8
2 2.8
3 2.9
Mean 2.83Std Dev 0.06
Table 1 showing the aerosol performance of the Feellife Air Force Portable Mesh Nebulizer
April 17, 2017 Piper Medical Protocol 17-0033 Page 5 of 9
2.72.9
2.6
19272083
2065
1018
1132
1120
934
916
913
9931167
1152
208
185
173
2.73
0.15
2025
85
1090
63
921
11
1104
96
189
18
PIPER MEDICAL Protocol 17-0033
PROTOCOL: Aerosol Performance the Feellife Air Force Portable Mesh Nebulizer
DISCUSSION
All equipment and laboratory processes met their specifications and requirements before and after testing. The amount of medication mass started at the beginning of each test was exactly accounted for at the end of each test within 15%. All acceptance criteria of the test were met.
April 17, 2017 Piper Medical Protocol 17-0033 Page 6 of 9
Piper Medical Products
Test: 7 Cascade Impactor: E-032
Protocol: 17-0033 Impactor Flow: 28.3 l/min
Nebulizer: Air Force Ambient Temp:oC20.0
Sample ID: 170323-4 Ambient RH%: 50.7 %
Drug: albuterol sulfate Fill Volume: 3.0 ml
Fill Drug Mass: 2,500 ug
Cutoff dia.
μ(μg/mL) Pg)
MMAD: 2.8 um
GSD: 2.7
Resp. Fraction: 57.8% % of C.I. 0.5-5 um USP Throat Mass % 6.7%
Total Dose: 1927 ug delivered Coarse Part. Frac%: 37.4%
Resp. Dose: 1018 ug 0.5-5 um Fine Part. Frac%: 39.7%
Treatment Time: 6.00 minutes Ultra Fine Frac%: 6.9%April 17, 2017 Piper Medical Protocol 17-0033 Page 7 of 9
Concen. Mass (%) (%)
50.22
20.5815.41
46.6317.34
11.749.07
8.37
265.70
195.62364.14
528.28158.75
104.2174.96
68.371760
15.1%
11.1%20.7%
30.0%9.0%
5.9%4.3%
3.9%100.0%
15.1%
26.2%46.9%
76.9%85.9%
91.8%96.1%100.0%
70.4%
Aerosol�output�rate 0.50±0.02
CI Sampled Mass %
ml/min
Piper Medical Products
Test: 8 Cascade Impactor: E-032
Protocol: 17-0033 Impactor Flow: 28.3 l/min
Nebulizer: Air Force Ambient Temp:oC20.5
Sample ID: 170323-5 Ambient RH%: 52.3 %
Drug: albuterol sulfate Fill Volume: 3.0 ml
Fill Drug Mass: 2,500 ug
Cutoff dia.
μ(μg/mL) Pg)
MMAD: 2.8 um
GSD: 2.9
Resp. Fraction: 61.8% % of C.I. 0.5-5 um USP Throat Mass % 10.1%
Total Dose: 2083 ug delivered Coarse Part. Frac%: 36.6%
Resp. Dose: 1132 ug 0.5-5 um Fine Part. Frac%: 47.7%
Treatment Time: 6.20 minutes Ultra Fine Frac%: 8.3%April 17, 2017 Piper Medical Protocol 17-0033 Page 8 of 9
(%) (%)
46.38
16.4214.10
54.7523.98
15.776.10
9.89
243.54
187.20382.65
584.12170.42
110.8967.63
84.291831
13.3%
10.2%20.9%
31.9%9.3%
6.1%3.7%
4.6%100.0%
13.3%
23.5%44.4%
76.3%85.6%
91.7%95.4%100.0%
73%
Aerosol�output�rate 0.48±0.02
CI Sampled Mass %
ml/min
Piper Medical Products
Test: 9 Cascade Impactor: E-032
Protocol: 17-0033 Impactor Flow: 28.3 l/min
Nebulizer: Air Force Ambient Temp:oC20.1
Sample ID: 170323-6 Ambient RH%: 49.2 %
Drug: albuterol sulfate Fill Volume: 3.0 ml
Fill Drug Mass: 2,500 ug
Cutoff dia.
μ(μg/mL) Pg)
MMAD: 2.9 um
GSD: 2.6
Resp. Fraction: 67.1% % of C.I. 0.5-5 um USP Throat Mass % 15.9%
Total Dose: 2065 ug delivered Coarse Part. Frac%: 36.5%
Resp. Dose: 1120 ug 0.5-5 um Fine Part. Frac%: 46.1%
Treatment Time: 6.10 minutes Ultra Fine Frac%: 7.4%April 17, 2017 Piper Medical Protocol 17-0033 Page 9 of 9
(%) (%)
37.72
16.3523.58
56.9212.63
18.903.79
6.12
225.82
181.37361.85
512.40148.13
106.5670.27
61.141668
13.5%
10.9%21.7%
30.7%8.9%
6.4%4.2%
3.7%100.0%
13.5%
24.4%46.1%
76.8%85.7%
92.1%96.3%100.0%
66.7%
Aerosol�output�rate 0.49±0.02
CI Sampled Mass %
ml/min
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