Cleanroom expertise as a foundation for healthy growth

New Hall in Pfreimd_web

Cleanroom Production in Pfreimd_web

Cleanroom Production in Pfreimd 2_web

Drug Delivery Systems such as syringe systems, insulin pens, and inhalers, as well as drug and pregnancy tests, share one common feature: they are all manufactured under appropriate environmental conditions in cleanrooms. A specialist and technology leader in the development and production of these systems and components for the international pharmaceutical and medical technology industry is Gerresheimer Medical Plastic Systems. A business unit of Gerresheimer AG, headquartered in Düsseldorf, with 47 locations in Europe, North and South America, and Asia, a group turnover of over one billion euros, and around 11,000 employees worldwide.

Pfreimd/Germany, Küssnacht/Switzerland, Indaiatuba/Brazil, Peachtree City/USA, Dongguan City/China, and Horšovský Týn/Czech Republic are the production sites of Gerresheimer Medical Plastic Systems, where the company currently has over approximately 18,000 m² of cleanroom space of ISO classes 7 and 8, as well as about 11,000 m² of cleanroom space of ISO class 9, and employs more than 1,800 staff. Over 30 years of experience in cleanroom manufacturing and covering the entire production chain—from injection molding to assembly and testing to packaging in the cleanroom—make the company a specialist in the production of high-quality medical plastic systems. To give an idea of the capacities: Gerresheimer Medical Plastic Systems produces around 100 million inhalers annually, among other products.

“We help people to succeed as a company,” says Manfred Baumann, CTO/COO, regarding the philosophy of Gerresheimer Medical Plastic Systems. The success with annual double-digit growth rates speaks for itself. Accordingly, the company has ambitious plans to expand its global production capacities. From 2012 to 2014, the production area is to be expanded by over 17,000 m², with more than 14,000 m² of that being cleanroom space of classes 7 and 8 according to DIN EN ISO 14644. This corresponds to a 50% increase in cleanrooms of classes 7, 8, and 9, totaling around 45,000 m². With 400 injection molding machines and 120 assembly lines, systems and components of the highest quality are produced on these areas today and in the near future.

Modern Cleanroom Production: Two Locations as Examples

Let’s shift our focus from global activities to two of the company's four European production sites, starting with Horšovský Týn in the Czech Republic, near the German border and about 40 kilometers from Pilsen.

Since 2003, production has been taking place in Horšovský Týn within a cleanroom, including the largest cleanroom of Gerresheimer Medical Plastic Systems. It covers an area of 3,500 m² and complies with ISO class 8. Validation was completed in January 2012. Since close contact with customers and transparency of the new cleanroom are important for the company, glass walls were integrated to provide visitors with an unobstructed view of the production rooms. Both renowned external partners like ONI and internal cleanroom engineers are responsible for planning and implementing temperature, humidity, pre- and fine-filtering, and particle measurement.

The energy efficiency of ventilation systems and cleanroom technology in industrial operations is more important today than ever before. This is due to the steadily rising energy prices, which have become a significant competitive factor in many industries. As a result, more and more companies are adopting proactive energy management. Gerresheimer Medical Plastic Systems is also doing this. This is evident in the new cleanroom, which features a cleanroom plenary with only 20% outside air supply, saving the company a lot of energy and costs through heat recovery.

However, Horšovský Týn is not only investing in cleanroom-compliant production but also in peripheral infrastructure. For example, a fully automated high-bay warehouse in ISO class 8 cleanroom is planned. Here, semi-finished products will be stored in the future, which should not come into contact with the environment before production.

Another highlight is the packaging, assembly, and labeling of rapid tests—for example, for drug testing—in Horšovský Týn. Under specially designed climate, temperature, and humidity conditions, the previously produced plastic housings are populated with test strips supplied by the customer. Logistics, including transportation via climate-controlled vehicles, is tailored to the specific product requirements. Continuous monitoring—including swab samples analyzed by the Medical Laboratory Weiden—ensures consistent quality, especially regarding cleanroom criteria.

However, not all products are manufactured in the cleanroom at Horšovský Týn. In the ISO class 9 cleanroom, the difference is immediately noticeable: here, in addition to people and machines, cartons and pallets are visible—items that have no place in ISO classes 7 and 8 cleanrooms. The cleanroom can be converted to meet class 8 requirements in the shortest possible time: the corresponding airlocks are available; only the air filters need to be replaced.

Location Pfreimd in the Upper Palatinate Forest

Returning to Germany, we take a detour to Pfreimd in the Upper Palatinate Forest. The site has a production area of 12,000 m², including 8,000 m² of cleanroom and 3,000 m² of sterile room. Seven days a week, around the clock, highly automated production of customer-specific plastic systems takes place here using 91 injection molding machines with clamping forces ranging from 15 to 250 tons and 22 fully automated assembly lines—fast, cost-optimized, and with consistently high quality.

The Pfreimd plant, like all Gerresheimer Medical Plastic Systems facilities, is certified according to DIN EN ISO 9001:2008, DIN EN ISO 13485:2003, and DIN EN ISO 14001:2004. Additionally, the site has received the Pharmaceutical Manufacturing License and the HGMP manufacturer’s license EEC. The plant also holds a manufacturer’s license under the Medicines Act and the certification for accreditation as an “Overseas Manufacturer” in Japan.

To meet customer requirements for a complete solution—including injection molding, assembly, packaging, finishing, and pharmaceutical assembly—a pharmaceutical filling and packaging area was established at the Pfreimd site. Important to note: when manufacturing different pharmaceutical products, production areas must be physically separated. Therefore, the area is designed according to a flexible zone concept and includes three classified and validated cleanrooms according to GMP Class D (ISO 8), ranging in size from 70 to 90 m². The modular production cells are separated by pressure cascades, and rooms equipped with assembly, filling, and testing equipment are designed according to the Medicines Act guidelines.

Even in Pfreimd, Gerresheimer Medical Plastic Systems’ expansive strategy can be seen in impressive figures. The capacities will be expanded by 4,500 m² of cleanroom space of classes 7 and 8, as well as 600 m² of high-bay storage with approximately 2,400 pallet positions in ISO class 8 by 2014. With investment costs of around 2,800 to 3,500 euros per square meter, this is one of the largest individual investments in the region.

First-class technologies, convincing innovations, and targeted investments, combined with high industrialization and cleanroom expertise: a foundation on which Gerresheimer Medical Plastic Systems secures sustainable success—and effective help for people around the world.