IMA
Aseptic filling is one of the most critical phases of pharmaceutical production processes. In addition to maintain the necessary aseptic conditions, it is essential to ensure extremely precise vial filling in the shortest possible time. In order to meet these requirements, IMA Life has introduced the Xtrema LV (large volume) in-line filling and stoppering machine with the Micro Motion mass flowmeter from Emerson Process Management.
Headquartered in Ozzano dell’Emilia, Bologna, Italy, IMA Group is proud to be at the forefront of the aseptic processing and filling sector and IMA Life, one of its pharmaceutical divisions, boasts 50 technicians and engineers dedicated to development and product innovation, resulting in the realisation of machines such as the Xtrema LV, offering an output of up to 600 PCs per minute for the dosing of liquids in aseptic environments.
The impressive filling range, accuracy and repeatability achieved by the Xtrema LV can be attributed to the Micro Motion mass flowmeter supplied by Emerson Process Management, whose staff has worked with the R&D Department of Company in a development process lasted five years.
Ivan Ragazzini, responsible for hardware and software at IMA Life, said an ergonomic issue led the company to consider using micro motion mass flowmeters over volumetric or peristaltic pumps: "The use of 500 ml or 1 l syringes in a linear machine for an aseptic environment is not recommended since this involves the set up of fractionated dosages, leading to implications in terms of filling accuracy, incorrect filling risks, etc., not to mention the cost impacts and the implementation of further procedures to be applied at every batch change.
"So, 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 of 24 devices, the Xtrema LV employs eight universal measuring instruments that, whatever the liquid to be filled in the range 50–1,000 ml, do not need to be disassembled either at the batch change or in the cleaning and sanitising phases."
"With the mass flowmeter, we were able to get a very good accuracy result — 0.5% in 3-Sigma on a production batch lasting eight hours. As an example, assuming you make a batch of 200 doses per minute for an entire work shift, statistical feedback tells us that on nearly 100,000 products, the nonconformity bottles would be around 10 units."
This high level of accuracy leads to two advantages. First, there is the absolute certainty of dosage, in other words, of the exact quantity of product inside each vial. Second, the customer is confident of having produced the largest number of vials possible within the tolerance range allowed by the regulations.
The Xtrema LV machine is customisable to fulfil customers' specific requirements. Tailorable features can be summed up as follows: wide filling range, from 50 ml up to 1 l (large volume parenterals); high accuracy and repeatability; and flexibility in batch changes and in CIP (clean in place) and SIP operations (sterilise in place). All of these potential customisations are independent of the type of product to be filled in, filing volume requirements, product temperature or density.