Designed for expansion

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Dr. Werner Brand and Christian Grüner

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The Life Sciences newcomer Apurano has developed a unique process for manufacturing and filling pharmaceuticals and dietary supplements, aiming to capture a piece of this dynamic market with its innovative health products. The production environment in the company's new building was optimally realized in accordance with a modular cleanroom concept from SPETEC, tailored precisely to the detailed specifications and completed in a short time.

The number of allergy sufferers is continuously increasing, more and more people suffer from autoimmune diseases, with cases of neurodermatitis, asthma, and psoriasis rising, as well as ulcerative colitis or Crohn's disease. On the other hand, in Germany, 13.5 million people take vitamins as dietary supplements daily. Both areas of human health represent enormous markets with huge growth potential. Here, the startup company Apurano Life Sciences GmbH from Upper Bavaria's Warngau wants to make a mark and is optimistic about its chances due to its patented PuranoTec® process. The signs point to growth.

The high-tech phytoceuticals developed and produced by Apurano have the invaluable advantage of converting poorly water-soluble components of medicinal plants or vital mushrooms into a liquid form that is optimally absorbed by the human body, entirely without chemicals or preservatives. The products are sprayed into the inside of the cheeks and under the tongue using an AktivSpray, where all plant or mushroom components are absorbed through the oral mucosa due to their specific surface properties. This partly eliminates the need for metabolism through the liver and also improves the absorption of the natural health products, which in turn increases effectiveness and reduces costs for the user.

Ancient problem solved with high-tech

With the innovative and patented PuranoTec® process, Apurano thus addresses an old problem in natural medicine: many active ingredients of effective medicinal plants are not water-soluble and can therefore only be absorbed to a very limited extent through the small intestine. The size of the particles also plays a crucial role here, as the small intestine acts as a filter and is permeable only to particles smaller than 5 micrometers. Therefore, many of the market-available herbal products in acid-resistant capsules are only minimally effective, as only a maximum of five percent of the water-insoluble or poorly water-soluble components can be absorbed. The special galenic formulation of Apurano products, such as the immunomodulating agent APUXAN®, delivers the active components directly into the organism, supporting an effective training of the
immune system. And all this without a doctor's prescription.

Since Apurano manufactures both dietary supplements and pharmaceuticals according to GMP standards, the young company naturally needed a high-performance cleanroom environment for the demanding processing and filling of medicinal mushrooms and medicinal plants in its brand-new building. Dr. Werner Brand, managing director of Apurano and developer of the patented process, began early to search for a provider that could not only meet his extensive specifications but also flexibly address challenges arising during construction and installation.

Modular cleanroom tailored to specifications

After intensive research and preliminary discussions, Brand found his realization partner with the Erding-based cleanroom specialist SPETEC. The modularity of the cleanroom components offered by SPETEC proved to be a significant advantage over other providers. The proximity and the high flexibility of SPETEC's experts within the ambitious schedule also played a positive role. Only about twelve months passed from the initial contact to commissioning. During this time, the entire company building, including the cleanroom area, was planned and realized in close coordination with the architect and relevant trades such as ventilation and climate technology.

The ultimately installed Laminar Flow Box system at Apurano was realized as a room-in-room solution, with the entire cleanroom area approximately 25 square meters and divided into various zones: starting with the sterilization room (Class D), where raw materials are introduced through an initial airlock from the receiving area to be ground and sterilized using a highly specialized and strictly secret process. Through a second airlock, the processed raw material is then pumped from a tank in the sterilization room via an elaborate hose system into another room (Class B). In this second room, a cleanroom cell of Class A is installed, where the filling system for the finished product is located. Within this Class A environment, the small application bottle with the active solution is filled, and the special spray head is mounted. From this cell, the bottle is then transferred via another airlock to the labeling area. To make this transfer of filled bottles contactless, two counter-rotating turntables were installed at the transfer station, which move the small bottles solely through centrifugal forces from one to the other.

The installed SPETEC® Laminar Flow Module FMS uses a high-performance filter of type H 14 with an efficiency of 99.995 percent, achieving an isolation factor of 10^4. This means that the air quality under the Laminar Flow Module is improved by at least a factor of 10,000 compared to the environment, and the particle concentration within the unit, from about 15 million/m³, is reduced to approximately 1,500 particles. This achieves cleanroom class 5 according to DIN ISO and class 100 according to US Fed. 209E. With this sophisticated room-in-room solution, the cleanroom area within the building shell was further optimized to meet GMP standards, which was a prerequisite for the approval of this modular cleanroom concept by the Bavarian government.

Filling system completely dismantled and reassembled

A particular challenge for Apurano was inserting the originally non-sterile assembled filling system into the sterile environment of the cleanroom. Since this is an essential prerequisite for the PuranoTec® process, all devices now located in the Class B cleanroom were completely disassembled down to the last screw, cleaned under Class D conditions, and carefully transferred into the Class B cleanroom environment through an elaborate procedure. There, the system was reassembled by technicians in cleanroom suits and put into operation. This process took considerable time, required significant effort, and tested everyone's nerves. However, Apurano's high standards for quality and purity are inherent to the company.

There were also many other details demanding special solutions and the attention of planners and technicians, such as the sorting of spray heads and bottles upon delivery or temperature regulation. In the end, everything was resolved optimally — not least, according to Dr. Brand, "through the commitment and enormous flexibility of SPETEC."

Today, all components function reliably and without issues, and the production achieves the planned capacity of 2,400 bottles per hour with a 98 percent availability — essentially uninterrupted — which Dr. Brand of Apurano appreciates just as much as the smooth certification of the cleanroom system by SPETEC.

Overall, Brand looks back with satisfaction on the construction and installation phase and especially on the collaboration with Spetec. Above all, "the fact that the specifications were 100 percent met during the qualification phase" gave him peace of mind at the time. "And since there have been no failures during operation so far, and the specified performance capability is maintained along with all other parameters, we can look confidently into the future," says the Apurano CEO with a smile. Fully aware that a quite exciting and potentially very successful future awaits the young company. After the successful product launch of APUXAN®, a dietary supplement that modulates the immune system, the company has now set its sights on the topic of sprayable vitamins and plans to enter a booming segment within an increasingly tight mass market in early 2018.

With their extremely high absorption ability directly through the oral mucosa, these vitamin products offer consumers a significant advantage, as the large quantities typically offered in other forms are largely not absorbed by the body, must be excreted again, and thus burden the liver. Apurano intends to leverage this application and innovation advantage. "With our vitamins, it’s not about how much is in there, but whether the body can absorb it optimally. And we are clearly ahead in that," explains Dr. Brand. This also applies to the B-vitamins currently in planning, which can also be delivered optimally to the body using the PuranoTec® process.

However, Brand is not worried about the expansion trap and capacity limits being quickly reached due to high market demand. "We can expand very quickly; we already have the land and plans. And the right cleanroom supplier too," says Brand confidently with a smile. SPETEC CEO Christian Grüner also looks forward to further projects, already eager for the next collaboration.