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.

P.IVA 01627720483
C.F. 01627720483

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TecnoTrend è un marchio di Comas Srl | FIRENZE FI017-28295 | REA SI-147595 | Capitale Sociale EURO 150.000,00