Saccharomyces cerevisiae, lysate

Particle size distribution (Granulometry)

Link to relevant study record(s)

Reference

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 05/02/2018 to 06/03/2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

ISO 13320 (Particle size analysis - Laser diffraction methods)

Version / remarks:

Version 2009

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: CIPAC MT 187 “Particle Size Analysis by Laser Diffraction”, Handbook K, 2007.

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

Laser scattering/diffraction

Type of particle tested:

other: dry powder module

Type of distribution:

volumetric distribution

Mass median aerodynamic diameter:

185.075 µm

Geometric standard deviation:

0.738

Remarks on result:

other: % STDVP = percentage standard deviation of the population = 0.4%

Key result

Percentile:

D10

Mean:

43.232 µm

St. dev.:

0.219

Remarks on result:

other: % STDVP = percentage standard deviation of the population=0.5%

Key result

Percentile:

D90

Mean:

400.038 µm

St. dev.:

7.283

No.:

#1

Size:

6 µm

Distribution:

0.07 %

Remarks on result:

other: Average on 5 runs

No.:

#2

Size:

10 µm

Distribution:

0.59 %

Remarks on result:

other: Average on 5 runs

No.:

#3

Size:

17.825 µm

Distribution:

2.2 %

Remarks on result:

other: Average on 5 runs

No.:

#4

Size:

31.698 µm

Distribution:

6.25 %

Remarks on result:

other: Average on 5 runs

No.:

#5

Size:

53 µm

Distribution:

13.23 %

Remarks on result:

other: Average on 5 runs

No.:

#6

Size:

90 µm

Distribution:

25.83 %

Remarks on result:

other: Average on 5 runs

No.:

#7

Size:

158.866 µm

Distribution:

48.84 %

Remarks on result:

other: Average on 5 runs

No.:

#8

Size:

282.508 µm

Distribution:

77.02 %

Remarks on result:

other: Average on 5 runs

No.:

#9

Size:

500 µm

Distribution:

95.44 %

Remarks on result:

other: Average on 5 runs

No.:

#10

Size:

893.367 µm

Distribution:

100 %

Remarks on result:

other: Average on 5 runs

Full Test Results

	RUN 1	RUN 2	RUN 3	RUN 4	RUN 5	Average**
Volumeweightedmean	185.619	193.000	200.503	197.886	196.872	196.622
Median	163.176	161.796	163.651	162.554	162.333	162.697
Mode	201.283	198.069	194.220	194.756	194.085	196.440
MMAD*	185.619	184.050	186.160	184.912	184.661	185.075
d10 - 10 % ofmaterialis<	42.936	43.133	43.515	43.120	43.455	43.232
d50 - 50 % ofmaterialis<	163.176	161.796	163.651	162.554	162.333	162.697
d90 - 90 % ofmaterialis<	394.547	391.169	411.997	403.736	399.980	400.038

All results are in μm

* Mass median aerodynamic diameter

** Average result is calculated from the entirety of data captured in each run and is not a simple arithmetic mean.

0.59 % by volume of sample was seen to be < 10.00μm

Standard Deviation result

	STDVP	% STDVP
d10 - 10 % of material is <	0.219	0.5
d50 - 50 % of material is <	0.649	0.4
d90 - 90 % of material is <	7.283	1.8
GSD	0.015	0.5
MMAD	0.738	0.4

GSD = Geometric standard deviation of the lognormal particle size distribution (calculated from d50/d15.78)

STDVP = standard deviation of the population

% STDVP = percentage standard deviation of the population

Conclusions:

The mass median aerodynamic diameter is 185.075 µm and the D50 is 162.697 ± 0.649 µm .

Executive summary:

The particle size distribution of Saccharomyces Cerevisiae, Lysate was determined accoding to ISO 13320:2009 “Particle Size Analysis – Laser Diffraction Methods”, and compliant with GLP.

The test was performed on the sample as received using the Laser Diffraction Particle Size Analyser. The particle size was analysed over the range 0.02 μm to 2000 μm and 5 runs were conducted.

The mass median aerodynamic diameter is 185.075 µm. The D10 is 43.232 ± 0.219 µm , the D50 is 162.697 ± 0.649 µm and the D90 is 400.038 ± 7.283 µm. The coefficients of variation show a good repeatability with 0.5%, 0.4% and 1.8% respectively, within the acceptable limits of the ISO method.

The particle size distibution study is classified as acceptable, and satisfies the guideline requirements of the ISO 13320:2009.

Description of key information

The mass median aerodynamic diameter is 185.075 µm and the D50 is 162.697 ±  0.649 µm .

Additional information

The particle size distribution of Saccharomyces Cerevisiae, Lysate was determined accoding to ISO 13320:2009 “Particle Size Analysis – Laser Diffraction Methods”, and compliant with GLP.

The test was performed on the sample as received using the Laser Diffraction Particle Size Analyser. The particle size was analysed over the range 0.02 μm to 2000 μm and 5 runs were conducted.

The mass median aerodynamic diameter is 185.075 µm. The D10 is 43.232 ± 0.219 µm , the D50 is 162.697 ± 0.649 µm and the D90 is 400.038 ± 7.283 µm. The coefficients of variation show a good repeatability with 0.5%, 0.4% and 1.8% respectively, within the acceptable limits of the ISO method.