PROTOCOL 17-0033 - feellife.com file2.7 piper medical sop-e-128 – microbalance operation 2.8 piper...

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


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




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.




Figure 1 showing the test set up for sampling aerosol from the Air Force




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


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



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.


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








Cutoff dia.

μ(μg/mL) Pg)

MMAD: 2.8 um

GSD: 2.9





(%) (%)

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%


CI Sampled Mass %

ml/min








Cutoff dia.

μ(μg/mL) Pg)

MMAD: 2.9 um

GSD: 2.6





(%) (%)

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%


CI Sampled Mass %

ml/min

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