Tecnotrend applied vacuum/pressure dosing system without the disk, realizing a series of microdosing machines for injectable powders, purposely designed to work in sterile environments, called microPURA ™ Ultra-Sterile ™
Tecnotrend applied vacuum/pressure dosing system without the disk, realizing a series of microdosing machines for injectable powders, purposely designed to work in sterile environments, called microPURA ™ Ultra-Sterile ™
To correctly evaluate the cleanness of this system, we report here below the results of the contamination test carried out by some of Tecnotrend’s customers.
Product classification
A pharmaceutical product can be classified as pure if, after being dissolved in water, the residual quantity of particles is below the following limits:
· 500 particles of max. dimension 25 micron per product m³
· 5000 particles of max. dimension 10 micron per product m³
Comparison results
• Machine with flexible pipes
previously used (produced by an American factory)
· 25 micron particles: around 500
· 10 micron particles: around 5000
Result: acceptable, at the limit of purity classification
• Machines with traditional disk
proposed by primary companies of the concerned sector (tests made on three different models of dosing machines, two of them made in Italy, one in Germany):
· 25 micron particles: many millions
· 10 micron particles: many millions
Result: too much contamination, non-acceptable machines
• microPURA ™ Ultra-Sterile ™ machine
produced by Tecnotrend:
· 25 micron particles: 43
· 10 micron particles: 470
Result:less than 10% of the limit value, which is 10 times better than the purity classification required.
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