The medical device and pharmaceutical industries are particularly strict. Standard operating procedures (SOPs) scrupulously stipulate how products must be manufactured. And national authorities, such as the FDA in the USA and the EMA in Europe, monitor closely to make sure that specifications are met. Even when production takes place in a third country. Their published warning letters are far worse than a complaint.
At the Vileda Professional Division of Freudenberg Home and Cleaning Solutions, a 20-strong team supports cleanroom operators around the globe, helping them pass announced and unannounced regulatory audits with flying colors. “We work in a demanding but relatively small niche market,” says Oliver Bloch, Global Business Development Director Controlled Environment (CE). With “small” he is alluding to the small cleaning footprint of the cleanroom business compared to the rest of the industrial and institutional sector. Cleanroom hygiene is more challenging though. After all, any manufacturing facility that operates in line with ISO or GMP (Good Manufacturing Practice) guidelines must have a certified cleaning system capable of producing consistent results. The team focuses on providing advice to minimize subsequent patient risk as early as the production stage and to prevent cross-contamination. Equally important is the provision of advice on existing guideline compliance.