How to Maintain Aseptic Conditions When Filling Vials

Related Vendors

Glatt Ingenieurtechnik GmbH

Anton Paar GmbH

ProMinent GmbH

IMA Industria Macchine Automatiche SpA

While counting on check weighing system technology, thus granting a double cross-checking (tare input detection and output gross weight), the machine does not use any conventional pumps, nor time-pressure and not even Peristaltic Pumps, but n. 8 Micro Motion mass flow meters installed upstream the filling nozzles.

From 50 ml to 1 Litre, All with One Tool

One of the reasons for implementing the flow mass measure was the result of an ergonomic problem. The use of 1 liter or 500 ml syringes in a linear machine for aseptic environment is not recommended since this would involve the set up of fractionated dosages, with consequent implications in terms of filling accuracy, risks of incorrect filling, etc. Not to mention the cost impacts and the implementation of further procedures to be applied at every batch change.

The solution? Rather than equipping each of the eight heads of three dosage syringes from 50-150 ml, 150-400 ml and 400-600 ml — which would lead to a total equipment of 24 devices, the new Xtrema LV employs 8 universal measuring instruments that, whatever the liquid to be filled in the range 50-1000 ml, do not need to be disassembled neither at the batch change, nor in cleaning and sanitizing phases.

Achieving Precise Accuracy

By this solution, which is alternative to volumetric or peristaltic pumps, Ima gets a very good accuracy result: 0.5 % in 3-Sigma on production batch lasting 8 hours. As an example, assuming a batch of 200 doses per minute for an entire work shift, statistical feedback tells that on nearly 100,000 products, the nonconformity bottles would be around 10 units.

This high level of accuracy leads to two advantages. First pharmacists have the absolute certainty of the dosage, in other words, of the exact quantity of product filled inside each vial. Ensuring repeatability and accuracy the system provides you with the confidence of having produced the largest number of vials as possible within the tolerance range allowed by the regulations.

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