"Not just clean, but pure." – Why cleanroom production is becoming more and more important.

When speaking of functional parts and packaging for the pharmaceutical industry, this phrase is not a slogan but rather a crucial difference: at Pöppelmann FAMAC®, certain plastic solutions must be manufactured in an environment with extremely clean air. A cleanroom fulfils these conditions.

In ancient times, doctors had already recognised the critical importance of cleanliness when controlling diseases. However, the concept of sterility did not reach a scientific stage before the beginning of the 19th century – in a kitchen. It was in 1803 when the French inventor François Nicolas Appert was officially recognised as being the first person to have ever produced sterile food. The Frenchman had discovered that food can be preserved by boiling. This pioneering discovery and achievement of sterile product filling can be regarded as the origin of cleanroom technology.

When dust and bacteria are excluded.

Our ambient air is full of fine dust, bacteria, viruses and pollen. Such air contamination is negligible under normal production conditions. However, this is not the case when it comes to cleanroom production. Pöppelmann FAMAC®, the plastics expert from Lohne, has been producing product solutions under cleanroom conditions since 2004. Our goal is to protect vulnerable processes from even the slightest contamination, be it organic or inorganic particles. This might seem quite simple at first glance. However, when put into practice, it requires an enormous range of technological and logistic measures because a pure environment can be affected by many sources and influences. Even humans shed an incredible amount of hair, skin particles and water droplets, which can be fatal to certain products, rendering them unusable.

Why purity requires hard work.

The cleanroom technology implemented at Pöppelmann FAMAC® has to deal with extremely complex tasks. These include the control of ventilation, filters, building structure, machinery, materials, surfaces, electrostatics, airlocks and even logistics. Even employees must be trained before being allowed to work in the cleanrooms. The concentration of airborne particles is defined in applicable standards and is regulated via air flow and air pressure. The currently applicable general standard is EN ISO 14644, which specifies the exact requirements of a cleanroom and divides cleanrooms into different classes depending on the permissible concentration of particles. Each of these purity classes stands for a certain concentration limit of particles or colony-forming units (CFU), i.e. germs. In order to meet the specific requirements for the medical and pharmaceutical industries, and biotechnology, the cleanroom production facility in Lohne has been approved to Class 7, GMP Standard – C. This means that the particle and germ concentration never exceeds 350,000 particles/m3 down to a size of 0.5 μm and less than 100 germ formers/m3.

Highest demands on cleanliness – an example from real life.

One of the projects that has been successfully implemented by Pöppelmann FAMAC® under cleanroom conditions is the production of a component for an inhaler – a medical product used to treat chronic or acute respiratory diseases. This seemingly small but highly sensitive component is subject to the most stringent of purity standards. To keep possible contamination by particles or even germs to a minimum, many plastic solutions for the medical and international pharmaceutical industries may only be produced in cleanrooms certified to Class 7 or higher. Requirements are particularly strict for the medical industry and there are numerous guidelines that must be implemented and adhered to, especially when it comes to purity. After all, customers must be able to rely one hundred percent on a product that fully meets the demanded requirements. When Patrick Keim, project coordinator at Pöppelmann FAMAC®, was entrusted with the task of developing and producing the inhaler component, he knew straight away that this project would involve a great deal of responsibility. "The main focus always lies on protecting the patient", says Patrick Keim. "Everything has to fit to a hundredth of a millimetre and comply with purity and hygiene standards. If I were a patient, I would also want everything to work flawlessly." At Pöppelmann FAMAC® everything is inspected to the tiniest detail to guarantee an end-product of the highest quality – not just in the interest of the customer but first and foremost to the benefit of the patient.

Companies that recognise this potential and understand cleanroom technology as a prerequisite for developing and implementing new technological work procedures will sooner or later be able to take a favourable economic position. According to the results of a market research conducted by the Mcilvaine Company, the cleanroom subject will continue expanding in the coming years – especially in the plastics processing industry. Being one of the market leaders in the field of development and production of technical functional parts and packaging for the food, pharmaceutical, cosmetics industries, Pöppelmann FAMAC® looks to future challenges with confidence.

Get to know Patrick Keim in person.
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Pöppelmann FAMAC®
+49 4442 982-3900
famac@poeppelmann.com