Blendhg to pharmaceutlcal standards: production begins at SternMaid's exemplary new pant.

Maximum product safety, traceability and purity were the required design specifications for SternMaid's new pharmaceutical-type blending plant. The recent commissioning of the plant has enabled the contract-manufacturing firm in Wittenburg, Germany, to extend and optimize its compounding range to include highly sensitive applications such as baby food, food supplements and vitamin mixtures.

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A New Link in the Service Chain

SternMaid is one of Europe's best-known contract manufacturers of foods. food ingredients and food supplements in powder form. Besides its routine blending and filling business, the innovative company offers tailor-made solutions that include the purchase of raw materials, product optimization, quality assurance and documentation, and even the delivery of finished products. The new plant adds a further link to the service chain. "The new project perfectly complements our existing range," says the firm's commercial manager, Mark Riemer. "It raises our production process to the pharmaceutical level so that we can open up additional market segments with a promising future."

One field in which Riemer sees great potential is making up individual base and active substances for medicines that are available without a prescription, so-called OTC products. And baby food, which is subject to very strict hygiene requirements, will soon be owing off the production line in Wittenburg too. Another field envisaged by the Wittenburg plant is the fast-growing market for allergen-free compounds: "Assuming that sufficient care has been taken in the choice of raw materials, production and transport, we can now compound allergen-free products," says Riemer, illustrating the advantages of a plant designed to exclude any risk of contamination. The blending and filling of clear-soluble vitamins--such as those used by the fruit juice industry--is yet another potential application. "Even the smallest trace of a conventional carrier, such as starch, in these additives would make the drink cloudy."

By No Means "Off the Peg"

The new container blending line went into operation at the end of April 2008--after a year of planning, 8 months of construction work and a capital expenditure of four million Euros. The high-tech plant incorporates many different innovations: special prototypes in the fields of control technology and mechanical engineering were developed in co-operation with component suppliers. "In most cases, standard solutions were out of the question," explains Gunter Kock, technical manager, "because we wanted to achieve the greatest possible exibility regarding batch size and product range, as well as maximum product safety."

Compounding without Residues

To ensure optimum hygiene in the new wing of the building, it was decided to physically separate the individual production steps. As a result, there are three different hygiene zones with separate rooms for depalletizing, weighing, feeding, blending, sifting, filling and palletizing. In addition, there are cleaning, changing and recreation rooms, hygiene air locks, a technical control room and a production office.

Optimum Batch Traceability

In the new plant, the entire process can be validated. To meet this requirement, all substances added to the product can be scanned in by means of a customized EDP program during the weighing procedure in the feed room. This makes it possible to trace, at any time, which raw material from which batch is in which blending container. Every mixture constitutes a separate batch, which means that all the batches can be traced precisely.

Bespoke Blending Equipment

The central feature of the new plant is the Bohle Container Mixer for pharmaceutical products, which works on the countercurrent principle. SternMaid deliberately chose a supplier that works chie y for the pharmaceutical industry and therefore has the necessary experience in handling extremely sensitive mixtures. The free-fall system is a particularly gentle method of processing raw materials. The compounds are mixed in a rotating container at a maximum of six revolutions per minute and are therefore exposed to very little mechanical stress. To achieve a perfectly homogeneous blend, despite such gentle processing, and even with difficult mixtures, SternMaid had a special version of the equipment designed: if necessary, a cutter head can be inserted into the lid of the container. The speed of this dissolver can be controlled to suit the product by means of an individually adjustable frequency regulator, so that even particles of extremely different sizes can be mixed with optimum results.

Based on years of experience in handling powders, technical manager, Gunter Kock, made sure yet another option was included when the plant was planned: liquids--such as avourings--can easily be sprayed onto the dry substances, which also permits dedusting or instantizing. "A container blending plant built to pharmaceutical standards, and fitted with special tools and a device for adding liquids. That must surely be unique in the industry," Kock maintains. The gross volume of the Bohle mixer is 2200 L, which allows a volume of 200-1000 kg to be blended. At SternMaid, the average filling is about 800 kg. The large equipment was chosen to minimize the cost of analyses, which have to be performed on each batch when extremely sensitive products are blended. But to serve customers ordering small quantities, an additional pharmaceutical blender with a working capacity of 210 L was installed as part of the orientation towards pharmaceutical quality. "This investment will enable us to fill the gap between 20 and 125 kg too," says Mark Riemer, speaking of the company's newly acquired diversity.

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Airtight Filling

The mixture leaves the blender, via the closed system, through a conical discharge section in such a way that the ambient air does not come into contact with the product. The filling system is fitted with exible PVC hoses instead of rigid pipes and dosing screws. "This solves the problem of dead ends where product residue can accumulate," says Riemer, explaining the advantages of the design. For the filling procedure, too, there is the option of working without any risk of contamination. Besides being discharged via a butter y valve constructed to prevent any subsequent trickling, the product can be filled through continuous hoses and heat-sealed into the packs. The heat-sealing station also offers the possibility of treating sensitive products with protective gas. In the "white" area--the zone with the highest level of hygiene--the conditions are almost akin to those of a hospital operating room. All the equipment and the ceilings, walls and oors can be cleaned quickly and easily. All the supply elements are housed in pharmaceutical hygiene panels; ush-fitting windows prevent dust particles from settling on the frame. Even the oor trucks are models of cleanliness: instead of ordinary fork-lift trucks, only electric lifters and lift-mast carts made of the finest stainless steel are used. And, of course, the ventilation system re ects the sophisticated hygiene requirements too. The quality and conduction of the air can be adjusted to the product's requirements, even up to the standard for clean room Class D.

Increased Capacity

With a planned production volume of 4000 tonnes, the new plant increases SternMaid's total capacity to about 40,000 tonnes/year. New outsourcing customers can audit the plant at any time according to their own rules. General certifications. such as ISO 9001:2000 and IFS, will not be done at SternMaid until next year. But one thing is certain: as it stands today, this exemplary plant will pass such quality inspectors with ying colours.

For more information

Nicole Schulze (Marketing)

SternMaid GmbH & Co. KG

An der Alster 81

D-20099 Hamburg. Germany.

Tel. [phone]

[e-mail]

www.sternmaid.de