Few industries are as strictly regulated as the pharmaceuticals sector. And those regulations entail adhering to good manufacturing practice (GMP), which encompasses specific quality assurance guidelines for the production process and environment. Commissioning a new plant for manufacturing or packaging medicines without the appropriate qualification in line with health authorities’ requirements? Out of the question! Everything from the materials, through piping and seals, to surface finishes and high-purity media must undergo the same level of precision testing and validation as the cleaning and manufacturing processes or plant control systems. Any changes to the production plant have to be documented and approved. That requires expertise and an exacting approach.
That’s exactly what defines the experts at Bilfinger Peters Engineering, who have been working with chemicals and pharmaceuticals businesses for 25 years. In 2010, the company moved into plant qualification. What started out with just two people has subsequently evolved into a full-fledged team under the leadership of Daniel Effertz, deputy site manager in Ingelheim, who heads up qualification/validation and documentation at Bilfinger Peters Engineering. Most of his colleagues are process technology engineers but they also include pharmaceutical engineers. This pool of expertise makes Bilfinger a reliable partner in plant qualification and validation. “We take on re-qualification needs arising from refurbishment or plant upgrades as well as first-time or prospective qualification, as when customers invest in new plants,” explains Daniel Effertz.
After entering the pharmaceuticals market with Boehringer Ingelheim in 1997, Bilfinger forged a longstanding cooperation that endures to this day. Several Bilfinger staff members are a firm feature at the plant in Ingelheim, ensuring that they are on hand whenever equipment needs to be commissioned or processes altered. For example, when a project called for the installation of three new isolators. These were key to hermetically sealing modules, mixing robots or screening systems, thus preventing the active ingredients to be produced from coming into contact with the environment. Daniel Effertz’s team handled all the steps in the process, from defining product specifications to reviewing and evaluating quotes received, from assessing risks and drafting performance specifications to testing as well as from acceptance to the plant’s eventual qualification, including precise documentation.