Yes, our components are manufactured under controlled conditions and offer consistent quality. We provide all necessary documentation, such as 2.1 factory certificates, material certificates, and technical data sheets, to support your qualification processes.
GMP-compliant ventilation systems for pharmaceutical manufacturing
Validatable, low-contamination exhaust air technology for the highest quality standards
The pharmaceutical industry demands uncompromising purity, complete documentation, and validatable processes. Beck components meet these requirements through reproducible molded part quality, low-contamination surfaces, and comprehensive GMP-compliant documentation. From active ingredient production to cleanrooms and OEB zones for highly potent APIs: Our systems provide you with the safety, purity, and traceability that pharmaceutical processes demand.
Contact usGMP Compliance and Cleanroom Suitability
GMP-compliant, reproducible molded part quality
Pharmaceutical plants require a high degree of uniformity and documentable component quality; Beck’s thermoformed, seamless molded parts deliver consistent geometry, which is not strictly required in traditional chemical plants. Every component is manufactured under controlled conditions and is fully traceable.
Low-contamination, easily disinfectable surfaces
Unlike in laboratory construction, microbiological control is a top priority in the pharmaceutical industry—the smooth surfaces can be cleaned and disinfected in a validated manner without material degradation. This ensures reproducible cleaning results and prevents cross-contamination.
Low particle and emission levels for cleanroom classes up to ISO 5
Pharmaceutical production areas require particularly low particle emission; Beck’s seamless construction eliminates dead spaces, seams, and abrasive inner edges, making it clearly superior to metal or segmented solutions. Minimal turbulence further reduces particle resuspension.
Durability and safety in demanding environments
High resistance to pharmaceutical-specific cleaning and disinfecting agents
While the biotech industry tends to use milder CIP media, the pharmaceutical industry frequently employs a broader spectrum of ethanol, peroxides, and disinfectant solutions—Beck plastics remain stable over the long term. Even aggressive cleaning cycles do not compromise the material’s integrity.
Use in toxic or highly potent active ingredient areas (OEB zones)
For highly potent APIs (HPAPIs), an absolutely leak-tight, corrosion-free exhaust air ducting system is crucial; Beck systems maintain their material integrity even with aggressive, toxin-containing exhaust air, whereas metal pipe systems can corrode or outgas when exposed to condensing substances. This protects both personnel and product quality.
More information on Beck molded parts in the pharmaceutical industry
What documentation will I receive for validation purposes?
You will receive complete material certificates, factory certificates in accordance with DIN EN 10204, declarations of conformity, and technical documentation covering all relevant parameters for IQ/OQ/PQ processes.
Are Beck systems suitable for highly potent active pharmaceutical ingredients (HPAPI)?
Yes, especially in OEB (Occupational Exposure Banding) zones for highly potent APIs, our completely leak-proof, corrosion-resistant components offer maximum safety. The material remains stable over the long term even when exposed to toxic exhaust air and does not release any substances.
How can dead zones and hard-to-clean areas be avoided?
Our flow-optimized, seamless design minimizes dead spaces and seams. The smooth transitions allow for validated cleaning processes without leaving residues in hard-to-reach areas.
Which disinfectants can be used?
Beck plastics are resistant to a wide range of pharmaceutical-grade disinfectants, including ethanol, isopropanol, hydrogen peroxide, and peracetic acid. For specific requirements, we would be happy to advise you on the best material selection.
How is leak tightness ensured for cleanroom pressure cascades?
Our low-leakage components and precise connection systems ensure reliable pressure cascading between different cleanroom classes. Tight-sealing butterfly valves and precise flow controllers maintain the set pressures with high accuracy.
Can Beck components be integrated into existing pharmaceutical facilities?
Yes, thanks to the wide variety of molded parts and the modular system solution, Beck components can be easily integrated into existing systems or used to replace corroded metal sections.
Do you need GMP-compliant exhaust air systems for pharmaceutical processes?
Our team of experts will assist you in designing validatable solutions with complete documentation for your qualification processes.
Phone: +49-(0)69-380353-0
Fax: +49-(0)69-3808243
Email: info@beckplastic.com