Test Report
Test purposes:
To reduce the particles size of the emulsion to Nanometers range.
Product:
Liposomes emulsion
- Sample A and B (different in concentration) to be micronised
- Samples C and D (different concentration) already micronised with a not better specified high pressure technique
Picture 1- Panda 2K homogeniser (10 l/h @ 1500 bar).
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Test Homogenization conditions:
Trials have been performed in the Niro Soavi laboratory with:
The machine has been equipped and prepared for test as following:
- Low volume feeding hopper for pharma application
- Double homogenization stage
- Homogenizing valve: PS type on the first stage and on the second stage
- A cooler exchanger has been installed on the homogenizer outlet.
Product preparation procedure and Test conditions:
- In order to have sufficient product to be processed sample A and B have been diluted: 50% product +50% water total 132gA; 127g b
- Product inlet temperature 25°C
- Outlet temp. about 25°C
- Homo pressure: 1300 bar first passage (50 bar on the second stage)
- The product has bee recirculated for 10 total passages
Homogenization procedure description:
The samples have been produced in the following way:
- feed the machine with product into the feeding hopper
- start the machine
- adjust the desired pressure on the second and then on the first stage
- wait 15 seconds in order to be sure that the product that comes out is exactly the one at the pressure indicated by the manometer (the product that is coming out from the outlet pipe has to be discharged, it can be collect and processed afterwards)
- Recirculation has been performed by putting a pipe inside the hopper and calcuting time in relation of batch capacity in order to have a theoretic calculated number of total passages
- collect the sample with a clean container
- empty the machine
Analysis Method:
To verify the homogenization efficiency, samples have been analyzed by using:
a. Laser Particle size analyzer type Coulter N5 Sub micron Particle Size Analyzer uses Photon Correlation Spectroscopy (PCS), which determines particle size by measuring the rate of fluctuations in laser light intensity scattered by particles as they diffuse through a fluid. PCS is the only non-destructive method for measuring particle size down to a few nanometers. A customized optical model has been prepared.
Analysis results:
In table 1 tested operative conditions correlated with an average particle size result.
| Product sample |
Process |
Total Pressure (bar) |
N° of passages |
Mean size (NM) |
Standard deviation (NM) |
| A |
|
0 premixed |
0 |
324,2 |
|
| |
Homogenized |
1300/50 |
10 |
74,2 |
34,4 |
| B |
|
0 premixed |
0 |
364,4 |
|
| |
Homogenized |
1300/50 |
10 |
76,1 |
32,2 |
| C |
Micronised |
n.a. |
n.a. |
171,4 |
|
| D |
Micronised |
n.a. |
n.a. |
245,7 |
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Diagram 1
GEA Niro Soavi Homogenizer performances at 1300bar x 10 passes - Sample A and B before and after the homogenization
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High pressure GEA Niro Soavi Homogenization process 1300 bar_ 10 passes
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Diagram 2
Sample A and B homogenized with Niro Soavi technology compared with sample C and D micronised with different technology.
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Average particle size ( NM)
 average particle size
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Tests evaluation and final comments:
By considering tests and analysis performed we can identified the following vital points:
- The homogenizer technology is well performing
- The average of particle size after 10 passages is very satisfactory for both the products tested (see table 1).
- The results obtained with sample A and Sample B are much better when compared with sample C and D (see table 1 and Diagram 2)
- The result obtained (75NM average particle size) can be for sure improved with the following actions:
- by increasing the number of passes trough the homogenizer
- by change the formulation of the product: emulsifier type, quantity, quality
- pre-mix preparation and procedure.
- All the samples will be sent back to the customer attention for his test and analysis.
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