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Form-Fill-Seal/Filling & ClosingPharma/Medical PackagingBlister Packaging

Pharmaceutical packaging case study

A totally protected environment

pharmaceutical packaging
June 30, 2016

submitted by Datalogic

The Datalogic safety photoelectric barriers SG4-H, with their innovative stainless steel body and glass window, are the only ones that provide maximum mechanical protection for pharmaceutical processing and packaging machinery where daily washing and sterilizing is essential to prevent bacterial contamination. This is why the German company Bausch + Ströbel has chosen Datalogic, gaining a significant technological edge.

One of the most important applications in the pharmaceutical industry is the filling and sealing of bottles, vials or syringes in a totally protected environment, where the most stringent standards in terms of health, safety and quality are mandatory. The German company Bausch + Ströbel Maschinenfabrik Ilshofen GmbH + Co. KG, a worldwide leader in machinery for pharmaceutical packaging, has gained a marked technological edge through its collaboration with Datalogic.

“Right after my first visit to Bausch + Ströbel I realized that they would not be interested in products similar to those already offered by competitors,” says Daniele Lippi, packaging industry manager at Datalogic. “Looking at their machinery, I noticed stainless steel and ‘hygienic design’ lines, with the exception of a few yellow barriers protected by bulky transparent pipes; I then realized where we needed to work. We started developing the world’s first safety barriers made of stainless steel with IP69K protection, which we have patented!”

Preventing contamination

The pharmaceutical packaging process in a sterile environment requires several operations: sterilizing, filling, sealing, and the final packaging. In all phases it is absolutely vital to prevent any risk of contamination, of which the environment and operators are the main carriers.

For this reason, the Bausch + Ströbel packaging and filling machines are made completely airtight, by means of RABS (Restricted-Access Barrier Systems) and “Glove Box” systems. Access by the operator is possible only with gloves on the walls of the machine and where visibility is guaranteed by transparent glass or plastic materials.

Accident prevention safety barriers

The SG4-H accident prevention safety barriers are installed inside the machinery, on the side of the access holes for handling gloves, in order to act promptly and stop mechanical handling every time the worker puts a hand inside it. Bausch + Ströbel machines are characterized by high process speeds; they are able to fill up to 24,000 vials per hour and it has to be possible to inspect them, from any point where an accident might occur. “Our basic tenet is that the machine should be designed in order to be viewable and accessible at every potentially critical point, from the beginning to the end of the process,” explains Jürgen Poisel, an engineer at the production headquarters in Ilshofen.

Maximum protection requirements

Considering the assembling requirements inside the machine, and in the sterile filling department, the safety barriers need to comply with maximum protection requirements, IP69K and “hygienic design”. The design criteria call for an outside case made of stainless steel AISI 316L with roughness lower than 0.8 μm, rounded surfaces without gaps or sharp edges, glass windows, and no label. Therefore all information is laser marked. The Datalogic SG4-H barriers have other important features, such as three protection levels (150, 300 and 450mm), a compact profile of just 50 x 30 mm, four LEDs and a 7-segment display for diagnostics and alignment, and standard M12 connectors with 5 poles.

“For several years we have been looking for stainless steel safety barriers,” says Mr Poisel. “Our suppliers could not provide a suitable solution, which meant that we had to install the barriers inside transparent sealed pipes to guarantee protection from bacterial contamination and resistance to cleaning with aggressive detergent such as hydrogen peroxide. Finally, Datalogic developed the new SG4-H barriers which for us has meant a substantial saving in terms of time and installation costs, as well as a marked aesthetic and technological improvement of our machinery.”

Datalogic (datalogic.com) , an automatic data acquisition and industrial automation leader worldwide, is one of the main manufacturers of bar code readers, mobile computers, sensors, vision and laser marking systems.

KEYWORDS: filling filling and closing pharmaceutical technologies sterilizing

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