Complete assembly produced in clean room

Im Bempflinger Stammwerk von Maier + Partner erfolgte 2010 der Teilumbau in der Produktion, bei dem ein 480 m² großer Sauberraum entstanden ist. (Foto: Maier + Partner) / In 2010, partial conversion of the Maier + Partner Bempflingen main plant production facility took place, in which a 480 m² clean room was created. (Photo: Maier + Partner)

Die Komponenten der Stuhlentnahmeröhrchen werden auf Allroundern in einem Sauberraum produziert. (Foto: Maier + Partner) / The components of the stool sampling tubes are produced on Allrounders in a SaS2 clean room. (Photo: Maier + Partner)

Die Stuhlprobe mit dem Entnahmeröhrchen nicht nur sauber aufgenommen, sondern auch sicher und ohne Außeneinwirkung verschlossen und zur Analyse in die Labors transportiert werden. (Foto: Arburg) / With the stool sampling tube, the stool sample can not only be cleanly taken, but also safely stored free of external influences and transported to the laboratory for analysis. (Photo: Arburg)

Das Stuhlentnahmeröhrchen – das patentrechtlich geschützt ist – besteht aus einem transparenten Röhrchen, einem Abstreiftrichter, einem Schraubverschluss und einem Dosierstab mit spezieller Dosierspitze. (Foto: Arburg) / The stool sampling tube – which is patent-protected – consists of a transparent tube, a scraper funnel, a screw cap and a sampling stick with special metering tip. (Photo: Arburg)

Erich Maier gründete das Unternehmen 1972 in Bempflingen. (Foto: Arburg) / Erich Maier founded the company in Bempflingen (Germany) in 1972. (Photo: Arburg)

•    Maier + Partner produce components for laboratory diagnostics in high volumes
•    Stool sampling tubes are produced in high volumes in a class 8 clean room
•    Allrounder injection moulding technology also works problem-free in key positions

Most people are unaware of just how widespread the use of sampling tubes is for analysis purposes in the medical sector. This involves vital issues such as the detection of occult blood in the faeces, which may indicate the presence of a bowel tumour. Such tests are also used to determine the presence of bacteria, viruses or parasites, as well as problems with bile flow. It should therefore now be clear to all that the apparatus used for stool sampling is at least as important as the analysis process itself. Because all components that come into contact with the substances to be analysed must be extremely clean and contamination-optimised during high-volume production. At Maier + Partner Kunststofftechnik GmbH this is performed in a clean room on Allrounders from Arburg.

In order to precisely implement this type of production, a differentiation is made between various types of clean rooms and zones. According to the German VDA 19.2 classification, the SaS2 clean room is defined as follows: the clean room must be separated from other plant areas by means of a permanent structural partition and feature cleanliness regulations with regard to material and personnel movements between the room and the adjacent areas. Whereas air conditioning is sufficient for an SaS2 clean room, in the case of an SaS3 clean room, a room-in-room system with airlocks and clean-air equipment is mandatory.

Maier + Partner produces stool sampling tubes in clean room

The item belongs to the gastroenterology product group and consists of four individual components. In addition to the transparent tube for safe storage of the sample, these include a scraper funnel, a screw cap and a sampling stick with a special metering tip. Using this item, the stool sample can not only be cleanly taken, but also safely stored free of external influences and transported to the laboratory for analysis. Managing Director Erich Maier describes the key product information as follows: "Millions of units of this assembly are in use globally for testing purposes. It ensures simple, quick and clean sampling and is much more convenient to handle compared to the previous "envelope" system with multiple samples. The scraper funnel of the tube permits the taking of a precise amount of sample. The sampling system produced by us is the first worldwide that can be transported over long distances, by air for example, even when filled.

Arburg machine technology optimally suited to production of innovative system

In comparison with existing systems, the implementation of new developments necessitated new moulds and complete start-up and running-in of this production process. The innovations include, for example, automatic taking of the optimal sample amount by means of the scraper funnel, absolute air-tightness, also at low pressure in the case of air freight, as well as easy handling of the assembly in the laboratory. According to the specialists from Maier + Partner, the testing phase of the first moulds had already showed that the best results with regard to precision and reproducibility could be achieved on Arburg machines. For this reason, the Allrounders were then also used for high-volume production.

The production of all parts is performed on two hydraulic Allrounders with core pull control. All of the items are first series produced, then tested and preassembled before delivery to end customer R-Biopharm AG.

Complex mould technology meets the requirements

Use in the medical sector places high demands on mould design. According to Werner Maier, member of the management team together with company founder Erich Maier, "all items have a very low part weight and are produced in multi-cavity moulds." The mould for production of the tubes is equipped with four cavities and, like the funnel mould, is filled via a hot-runner with gate. The machine on which the tubes are produced is, like the Allrounder for the production of the caps, also equipped with core pull control, which is required for unscrewing the internal and external threads. The four-cavity funnel and cap moulds are also equipped with a material-protecting hot-runner system and, in the case of the funnel, with a gate. Finally, the sampling stick is produced in an eight-cavity mould via a hot-runner with gate.

The four components are made from different PPs and a PE, which are all approved for medical applications. When asked for further details, Werner Maier explains: "Due to customer confidentiality, I cannot comment further on this subject. Unfortunately, the precise material types used cannot be named."

Cooperation between Maier + Partner and Arburg has existed for decades

The company, which was founded in 1972 by Erich Maier in Bempflingen (Germany), has had a close business relationship with Arburg from the outset. Originally operating mainly in the fields of packaging, measuring spoons and hygiene items, the business was expanded into the area of clean-room production, which brought about a new customer structure, particularly in the laboratory technology and diagnostics areas.

Allrounder injection moulding machines were already being used before Maier + Partner entered the medical technology sector in 2005. In 2010, the production facility was partially converted, with 480 m² of the main plant in Bempflingen being transformed into a class 8 clean room according to ISO 14644/1.

Especially in the medical technology and laboratory equipment sectors, the two managing directors Erich and Werner Maier have high ambitions. Werner Maier says: "We are currently working on the certification of our production for medical products according to DIN ISO 13485. In this way, we wish to offer our customers in this sector added value in terms of service and support, which extends far beyond injection moulding."

Two production locations in Germany

The plastic items from Maier + Partner are mainly produced in large volumes and exclusively in Germany by a total of 80 employees at the two locations of Bempflingen (Swabia) and Crimmitschau (Saxony). A 2,100 m² production area is available for this purpose at the Swabian location and a further 3,700 m² in Saxony. The products and components are delivered to the food and luxury foodstuffs, medical technology and cosmetics industries, predominantly within Germany and Europe, in accordance with the most stringent deadline and quality requirements. Products include confectionary packaging, deodorant caps, laboratory equipment and measuring spoons, for example. Erich Maier says the following about his company's product range: "We not only work with the conventional machine arrangement and technology, but also with in-mould labelling (IML) and perform surface treatment on many of our components using plasma irradiation, in order to be able to perform downstream operations such as printing in a problem-free manner. We have therefore grown with the requirements of our customers."

Allrounders from Arburg used in key production

The total of twelve Allrounders used by Maier + Partner operate at all important key points in the company, including the clean room. The range of machine sizes covers distances between tie bars from 320 x 320 mm to 820 x 820 mm and clamping forces from 700 to 4,200 kN. Erich Maier looks back on consistently good times with Arburg: "Over the years, our experience with the machines has been really good. They are very reliable and low-maintenance and are characterised by high availability. Furthermore, their user-friendliness is very high thanks to the Selogica control system. These are all reasons for our use of the Allrounders throughout our production, because even in multi-shift operation – we operate in the fully continuous shift system on 340 days per annum – the technology has proved itself time and again."

Here, the Allrounders operate conventionally as stand-alone solutions as well as with robotic systems for frequent product changes or integrated in complete production cells in the case of continuously-produced parts. When asked what he particularly appreciates about Arburg, Erich Maier answered promptly: "The people from Lossburg have always helped us with know-how as well as the right technology and servicing whenever needed. You don't forget that. That's why we feel so well supported by the company up to the present day, because the entire product range has always been very close to our requirements. This also applies to the applications technology consulting and customer service. They are always close at hand when they are needed. Particularly the Arburg Applications Technology has provided us with efficient assistance on several occasions, which makes us optimistic with regard to future cooperation. When planning new capital investments, were therefore able to focus more closely on the topics of automation and complex production cells, especially for the medical technology sector ."