DIN EN ISO 14644 Cleanroom qualification

As one of the leading companies in the field of closing and dosing devices, SENSOPLAST focuses on quality, innovation and customer satisfaction.

To ensure the highest product quality, we rely on controlled production and storage areas that are safeguarded by a well thought-out zone concept, clearly regulated personnel and material flows, strict clothing and reprocessing regulations and regular internal and external monitoring intervals.

A test laboratory accredited to DIN EN ISO/IEC 17025:2018 has tested our production and storage areas and confirmed air purity class ISO 8/ISO 9 in accordance with DIN EN ISO 14644. Internal and external microbiological monitoring also confirms GMP grade D for the biocontamination of surfaces in accordance with Annex I of the EU GMP guidelines, which underlines our high standards of cleaning and disinfection.

These test results impressively confirm our commitment to the highest standards of quality, safety and hygiene. They are the result of intensive efforts and investments in state-of-the-art production technologies, first-class processes and highly qualified employees. We are proud of this further step forward.

Our customers benefit from these controlled and tested production areas in several ways:

• Increased safety:

o Our products are tested semi-annually by an independent laboratory for microbiological and particle testing.

o Prevention of cross-contamination: The strict separation of our production areas ensures that no mixing or contamination occurs.

• Regulatory compliance:

o Regulatory conformity: our products fulfill all legal requirements and meet the highest industry standards.

o Traceability: Complete documentation guarantees full transparency and enables comprehensive traceability.

• Highest quality:

o Through our controlled and monitored production conditions, we offer purer and higher quality products.

o Consistent production: Stable production conditions ensure consistently high product quality.

Our primary packaging and medical devices manufactured in controlled production and storage areas with zone concepts offer you the highest level of safety and quality.

They meet the strictest regulatory requirements, minimise the risk of contamination and guarantee seamless traceability.

SENSOPLAST: Safety, reliability and conformity for your products.