A clean thing

At Pöppelmann FAMAC, the injection molding machines operate from outside into the cleanroom; they can be disconnected if needed and used in other areas.

After demolding, the injection-molded parts fall onto a fully enclosed, cleanroom-compatible conveyor belt and are then transported to the cleanroom for further assembly, packaging, and finishing.

In the cleanroom of Pöppelmann FAMAC, the flawless process of production must be ensured. This also includes the inspection and visual examination of the produced parts.

The assembly also takes place at Pöppelmann FAMAC in a cleanroom, where it is guaranteed that there are fewer than 350,000 particles per cubic centimeter (< 0.6 µm) in the air.

To keep the amount of particles and germs in the air as low as possible, the employees wear special protective clothing and are trained on how to behave in the cleanroom.

For the medical technology and pharmaceutical industries, Pöppelmann FAMAC develops and manufactures plastic parts with the highest standards of cleanliness and durability.

To produce hygienic functional parts and packaging for the medical technology and pharmaceutical industry, Pöppelmann FAMAC has two cleanroom productions. The manufacturing of high-quality plastic injection-molded parts takes place here under the highest standards. Assembly, commissioning, and packaging of the products must also meet special cleanliness requirements.

When manufacturing plastic products for medical or pharmaceutical sectors, cleanliness and the dimensional stability of the products play an important role. This applies, for example, to reaction vessels or filter pallets – used as disposables in molecular diagnostics – but also to medical components, cartridges, or inhalation masks for children. For such applications, the particle and germ content of the plastic articles must be within certain limits upon delivery to the customer. Therefore, the production, assembly, commissioning, and packaging at Pöppelmann FAMAC are carried out in cleanroom conditions.

Production under cleanroom conditions

“Last year, we expanded our existing cleanroom in the FAMAC production with an additional cleanroom for commissioning and assembly work, covering an area of 400 square meters,” explains Engelbert Rechtien, Sales Manager at Pöppelmann FAMAC. Since 2004, the company has been manufacturing high-quality injection-molded products and assemblies, including packaging, for the medical technology and pharmaceutical industry under cleanroom conditions. The first cleanroom at the company’s Plant 1 was ISO Class 7, 60 square meters in size, and could accommodate eight machines. In 2011, a new cleanroom was put into operation at Plant 3, with 400 square meters and the capacity to connect 25 machines. This new cleanroom was deliberately installed in a different hall to provide the customer with maximum security regarding contingency. Last year, due to increasing order volumes, an additional cleanroom of the same size was added. “The fact that FAMAC customers value the high quality at Pöppelmann FAMAC is reflected in the expansion of cleanroom capacity to a total of 800 square meters,” says Rechtien.

Clean production in the cleanroom

At Pöppelmann FAMAC, the cleanroom production is qualified according to DIN EN ISO 14644 Class 7 and Class C of the EU GMP guideline. Additionally, a quality management system according to DIN EN ISO 13485:2010 oversees the manufacturing process. To maintain this high standard, regular measurements are taken to ensure particle count, temperature, and air exchange stay within defined limits. Based on a risk analysis, the cleanroom in Hall 32 was designed with a double air conditioning and filtration system. The consistent implementation of contingency measures ensures that production can continue even if one system fails. The constantly maintained overpressure ensures a continuous airflow out of the cleanroom. Regular checks ensure that fewer than 352,000 particles per cubic meter are present in the air, down to a size of ≤ 0.5 micrometers, and fewer than 100 colony-forming units per cubic meter. The room temperature is constantly maintained at 21 degrees Celsius.

Well-trained personnel for the cleanroom

To keep the amount of particles and germs in the air as low as possible, employees wear special cleanroom clothing and are regularly trained.

Joseph Willenbring is one of those who qualified through internal training for work in this specialized area. He has a personalized chip card for access and passes through three airlocks before reaching his workstation. His responsibilities include flawless production processes, meaning he is responsible for inspection and visual checks of the produced parts. Twice per shift, samples of the products are taken in a zip bag and transported via a conveyor belt to quality assurance. Willenbring and his colleagues work around the clock in a three-shift operation, with external contact only via telephone.

Safety is highly valued at Pöppelmann. Therefore, blood samples are regularly taken from cleanroom employees. A health certificate and a medical certificate also attest to their suitability for this special work environment. “One advantage for me is that I haven't had the flu since I started working at Pöppelmann FAMAC,” laughs Willenbring. “Maybe it’s also because of the clean workplace.”

The production takes place outdoors

In addition to cleanliness, economic efficiency is also a focus of the company. “Our injection molding machines produce from outside directly into the cleanroom,” explains Engelbert Rechtien. “But they can also be decoupled and used in other areas if needed.” The flexible use of the injection molding machines saves resources and makes the cleanroom production at Pöppelmann FAMAC particularly efficient.

There is also sufficient space outside the cleanroom for tool changes, maintenance, or retrofit work, and the machines are accessible from the outside. This allows for flexible responses to customer requirements without disrupting the cleanroom processes. An additional advantage of outsourcing the injection molding machines is that the cleanroom is not contaminated in case of a malfunction.

Control cabinets and all additional equipment are also located outside the cleanroom production. This reduces heat load, relieves air conditioning, and helps keep operating costs as low as possible.

Cleanroom transport system

But how do the injection-molded parts enter and exit the cleanroom cleanly? “The tool area is supplied with laminar flow with clean air, equipped with H14 HEPA filters,” explains Rechtien. After demolding, the good parts fall onto a fully enclosed, cleanroom-compatible conveyor belt. Complex or sensitive parts can alternatively be removed with a handling robot and placed on the belt. The injection-molded parts are then transported fully automatically into the cleanroom for further assembly, finishing, and packaging. All assembly and packaging equipment located in the cleanroom was designed according to GMP standards. During qualification, care was taken to ensure that the equipment is easy to clean and maintain during operation. They have no open screws, hidden corners, or surfaces where dust could accumulate.

After assembly and commissioning, the products are packed in a double foil bag and pass through a lock. They are then packed into cartons and stored. They arrive at the customer just as clean as when they left the cleanroom. “The requirements of our clients in medical technology and the pharmaceutical industry are very high when it comes to hygiene standards,” says Willenbring. “You can absolutely rely on Pöppelmann FAMAC.”