"Not just clean, but pure" – Why cleanroom manufacturing is becoming increasingly important

Inspection down to the smallest detail: Pöppelmann FAMAC® guarantees the highest purity.

When it comes to functional parts and packaging for the pharmaceutical industry, this sentence is not a slogan but a crucial difference: manufacturing certain plastic solutions at Pöppelmann FAMAC® requires an environment where the air is extremely clean. A cleanroom meets these conditions.

Since 2004, Pöppelmann FAMAC® has been producing product solutions under cleanroom conditions – with the goal of protecting sensitive processes from the smallest contaminants, whether organic or inorganic particles. In practice, this requires a comprehensive range of technological and organizational measures, as a pure environment is affected by many sources and influences. Humans also shed incredibly high amounts of hair, skin flakes, and water droplets. These have a fatal impact and make products unusable.

The cleanroom technology at Pöppelmann FAMAC® must solve extremely complex tasks. It involves controlling ventilation, filters, building structure, clothing, machinery, materials, surfaces, electrostatics, airlocks, and logistics. Employees must also be trained beforehand to be allowed to work in cleanrooms. To meet the special requirements of the medical and pharmaceutical industries, as well as biotechnology, the Lohne facility has a Class 7 cleanroom production, GMP standard – C. This means: the particle and germ count is less than 350,000 particles/m³ down to a size of 0.5 μm and fewer than 100 germs/m³.

Pöppelmann FAMAC® well positioned in cleanroom production

An example of a project that Pöppelmann FAMAC® successfully implemented under cleanroom conditions is the production of a component for an inhaler – a medical product used in the treatment of chronic or acute respiratory diseases. This seemingly small but highly sensitive component is subject to extremely high purity standards. Many plastics solutions for medicine or the international pharmaceutical industry may only be produced in cleanrooms of at least Class 7 to keep contamination from particles or germs as low as possible. The medical industry, in particular, has extremely high requirements and numerous guidelines, especially regarding cleanliness conditions, which must be implemented and adhered to. Ultimately, the customer must be able to rely 100% on everything meeting the specified standards. At Pöppelmann FAMAC®, everything is checked down to the smallest detail to ensure the highest quality in the end.

Companies that recognize the potential and understand the mastery of cleanroom technology as a prerequisite for developing and applying new technological processes will, sooner or later, gain a favorable economic position. According to market research results from Mcilvaine Company, the cleanroom area will continue to grow in the coming years – especially in the plastics processing industry. As one of the market leaders in the production of technical functional parts and packaging for the food, pharmaceutical, and cosmetics industries, Pöppelmann FAMAC® looks positively towards the upcoming challenges.