Decisive Cleanroom Competence

Fully electric machines guarantee best-of-class precision and efficiency

When it relocated to larger premises with a new cleanroom for injection moulding operations, V.A.R.I. - Lindal Group decided to switch to fully electric presses. These machines have allowed the Italian manufacturer of valves for pharmaceutical applications to comply with the increasingly stringent requirements of its customers while ensuring maximum precision and efficiency.

V.A.R.I., a company of the Lindal Group, is a leading manufacturer of valves and actuators for pharmaceutical aerosol products. For 25 years, it has produced 20-mm valves for CFC and HFA propellants that have been employed all over the world in a vast range of pharmaceutical applications. The company has an established presence in Europe, as well as in Russia, Asia, South America and Africa, with a market share of over 90% in some of these regions.

V.A.R.I. is located in Oggiono (near Lecco) in a modern site covering 60,000 sq.m including 1,500 sq.m devoted to cleanrooms, a laboratory of 300 sq.m, and 900 sq.m of office space. The new factory was built in 2009 from scratch and is equipped with ultramodern positive-pressure cleanrooms featuring HEPA filters for injection moulding processes in a strictly controlled environment. The new cleanroom includes fully electric injection moulding machines with a clamping force of 100 tonnes delivered by ENGEL, each with a HEPA laminar flow box above the clamping unit. All servoelectric drives are fanless and totally encapsulated, as is the injection unit. The completeness, size, functionality and dosing capacity of all the valves produced can be checked directly on the assembly lines. All the valves are laser-coded for total traceability. "We are the only manufacturer of these parts within the Lindal Group," remarks Giovanni Corti, plant manager at the Oggiono factory. "We are the aerosol competence centre for the international pharmaceuticals market." The Lindal Group, whose head offices are situated in Bad Oldesloe near Hamburg, Germany, has developed, produced and sold valves, spray heads and caps for all kinds of aerosol products in the cosmetics, household, technology, food and pharmaceutical industries since 1959. Lindal delivers more than 2 billion valves each year, and is thus one of the market leaders in this field. The Group boasts a global presence, with numerous subsidiaries and licensed dealers in more than 15 countries.

From the initial idea through to series production

Every year the new factory in Oggiono produces several million valves with a diameter of 20 mm. To adapt the single components the valves undergo a customisation step, because each change of recipe requires appropriate materials and structures. V.A.R.I. has its own laboratory and engineering departments to cope with these requirements. "We offer our customers a full service, from product tests to design and concept, through to series production," says Corti.

The cleanroom for injection moulding production is the heart of the new pharmaceutical division. Five ENGEL e-motion fully electric injection moulding machines were commissioned here in late 2010. V.A.R.I.’s move to the new facilities also meant that the company switched to fully electric machines. "Our customers have increasingly strict requisites, and this is reflected in our product portfolio. To be able to go on meeting these requisites in the future, we decided to invest in new injection moulding technology," Corti explains: "Fully electric machines ensure extremely clean operation and at the same time a high level of precision, and we need this for automated assembly downstream."

The fully electric drive system, the position measurements with absolute encoders and high precision linear guide rails provide for accurate movements. In combination with the autoprotect software, this provides extremely sensitive mould protection.

In the ENGEL e-motion series all machine movements are controlled by servoelectric drives, from injection and metering through to the mould and the ejector. This ensures a

high degree of efficiency, with virtually no energy consumption while the machine is idle. The servodrives have a central energy supply where the braking energy is recovered as electric energy and fed directly back into the power grid. Parallel motion of all drives reduces the dry cycle and cycle times, thus additionally improving efficiency.

Although Giovanni Corti had already used ENGEL machines at the former site, it was not merely a matter of course to continue working with ENGEL after the expansion and modernisation programme. Quotations from several machine manufacturers were examined and talks were held, with Corti paying attention to one thing in particular: the manufacturer's cleanroom competence. "As plastics processors we ourselves have only limited experience in the pharmaceutical field," Corti points out, "in other words we have to trust, absolutely, in the machine manufacturer's experience and know-how." And this was the point at which Corti quickly discovered major differences between the various bidders. Finally, ENGEL came in with an offer that proved convincing in all respects. The dependability and competence demonstrated by the Medical Business Unit were decisive for the purchase. But Corti also appreciates the proximity of ENGEL's Italian subsidiary in Vimercate, just half an hour’s drive from Oggiono. The staff of ENGEL Italia were just as familiar with the details of the project as Christoph Lhota, head of the ENGEL Medical Business Unit in Schwertberg, Austria. "Whenever I called with changes in the planning phase, everybody immediately knew what I was talking about," says Corti.

To avoid wasting time during the planning and commissioning stages, ENGEL was entrusted – as a turn-key supplier – with the delivery of the e-motion presses, the automation systems, the laminar flow boxes and the mould change system. The turn-key package also included the documentation for the cleanroom equipment (with the EverQ certificates) in line with GMP practices. "Not every machine builder is capable of supplying the required documentation scope," comments Corti, "you really have to take a very close look at the offers at the bidding stage."

A cleanroom in the cleanroom

At the new Oggiono factory the ENGEL e-motion machines are installed in an ISO 8 cleanroom. The clamping units on all of the e-motion presses are encapsulated and equipped with laminar flow boxes incorporating HEPA filters rated to Class ISO 7, just like the adjacent cleanroom where the valves are assembled. "The laminar flow boxes are totally custom built," emphasises Christoph Lhota, "we collaborated with our partner Max Petek Reinraumtechnik to come up with a custom solution here."

The fact that V.A.R.I. opted for the tiebarless variant of the e-motion machines is an advantage. This choice means more space in the mould area, which at the same time facilitates part handling and mould changes. To be able to bring in the moulds from the side without using a hoist, ENGEL integrated a mould change system including rollers and a trolley. Thanks to the trolley, the mould can easily be moved to the maintenance zone.

Each injection moulding machine is equipped with an ENGEL ERC 23 robot which takes care of part removal from the mould. The grippers were designed individually to meet the requirements of valve production, as a standard solution would not have been suitable for handling small parts with diameters of between 2 and 20 mm. After removing the parts, the grippers deposit them on a conveyor belt integrated into an ISO 7 enclosure. The conveyor belt transports the individual components through an air lock into the neighbouring intermediate storage. From this point on, the ISO 7 standards are complied with throughout.

Bound to grow

The intermediate storage fulfils several functions. This is where the quality control areas for the moulded parts are located and the individual components are packed for final transport to the assembly line in a third cleanroom near the other two. The valves are assembled in a fully automated process. The tolerance for the moulded parts is between 0.02 and 0.05 mm, a requirement which the fully electric ENGEL e-motion machines fulfil with ease.

The Chameleon of MDI valves

One size fits all

LINDAL Group provides the technique inside and the design “on top” of over 1.9 billion aerosols per year. Established in 1959 and never ceasing to innovate, LINDAL has become one of the global market leaders in aerosol technology.

VARI, part of the Lindal Group, is one of the world’s leading manufacturers of valves and actuators for pharmaceutical aerosol systems. VARI has manufactured 20mm metering valves for a wide range of pharmaceutical applications for over 25 years, supplying pharmaceutical companies all around the world. Part of the VARI products range is the KHFA valve, a pMDI valve completely manufactured and assembled in a clean-room environment with approaches and procedures consistent with the aims of cGMP.

The KHFA valve is the result of years of development and commercial use, which offers a valve design capable of maintaining its “prime” with SOLUTION formulations, while at the same time allowing “rapid-fill / rapid drain” with SUSPENSION formulations. The careful selection of materials for the valve components offer a valve with LOW level of extractables. Great care has been taken to avoid some of the more reactive species that can leach from some materials, which can adversely impact on the stability of the most sensitive drugs in solution. The outcome is a pMDI valve, a Chameleon, which offers superior performance with both solution and suspension formulations, without the need for design and material changes. 

The key enabling factors of the VARI KHFA valve are:

• Outstanding moisture barrier protection
• Low propellant loss
• Excellent metering consistency
• Rapid fill / rapid drain technology (NO need for priming)
• A design able to deliver small volumes
• Clean extractable profile
• Selection of compatible polymers
• Highly competitive price

For more information please contact:

V.A.R.I. S.P.A.
Sergio Monti
Via al Mognago, nr. 47
23848 OGGIONO (Lecco)

Tel +39 0341 269525
Fax +39 0341 269540



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