How to Maintain Aseptic Conditions When Filling Vials

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IMA Industria Macchine Automatiche SpA

The fast filling of products in aseptic environment is a very critical operation not only with regards to the accuracy, but also with regards to strict quality parameters that customers require during production. To get an idea of the quality required: during filling even a very slight product splash on vial body is a “non conformity”. This is the reason why valve control is not driven by flowmeter directly, but by a logic developed by Ima.

Flexibility has a Lot to Offer

The motion profiles which drive dispensing valves opening and closing operations have been developed by Ima and are maintained by soft logic PLC. The mass meter system is then used as a pure measuring instrument, whose features in terms of accuracy and frequency allowed the development of specific dosing profiles, able to eliminate the dripping, strokes and, as mentioned above, product splash on vial body. Obviously, all of that at a very high speed.”

In addition to the evident advantages in product, the high mass flow flexibility allowed Ima Life to obtain other benefits, such as for example in cleaning and sanitizing of the circuits. Ensuring the perfect cleanliness from the product tank to the nozzle, i.e. for all the way the product to be filled passes through, is not a technical matter to be taken for granted.

Riboflavin-Test Granted Cleanliness in a High Level

Cleaning in place and Sterilization in place validation processes was one of the most critical aspects of the whole project: actually the cross-contamination risk running from a batch to another must be reduced almost to zero. The conducted tests gave positive results confirming that the mass flow meter is an excellent solution also from this point of view, thanks to the absence of moving of
mechanical parts and stainless steel ducts with very low roughness.

There are international standard procedures on the basis of which it is possible to determine whether washing, prior to sterilization, has been effective. In other words, to verify if the necessary quantity of cleaning solution has reached all internal surfaces to avoid cross-contamination between the batch just ended and the next one.

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