Containment All Along the Line - The path to efficient operator protection in pharmaceutical drug manufacturing
From hormone treatments to cancer therapies, more and more often medicines contain high potency active pharmaceutical ingredients. During their processing, drug manufacturers are obliged to provide full protection for operators, products and the environment. At the same time, they have to maintain a high level of efficiency to defend their position against their global competitors. Excellence United offers the appropriate strategy for achieving this: process-integrated containment.
The handling of potent substances is becoming an increasingly important topic for pharma manufacturers. There has especially been an increase in the share of high potency active pharmaceutical ingredients (HPAPIs). One quarter of the active ingredients – in production and development – today are already classed as highly potent. Until 2021 the market for HPAPIs is expected to experience above-average growth of roughly 8.5%, compared to around 6% for the pharma market as a whole. This trend is also having an impact on the pharmaceutical production process. Manufacturers have to comply with specific limits laid down, among others, by the Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). “The demands made on production machinery are increasing, especially with regard to sealing and cleaning processes,” explains Jörg Gierds, the product manager for containment at Fette Compacting. “At the same time, manufacturers are looking for contamination protection that enables them to maintain their existing high level of production efficiency. The decisive factor in achieving this is that containment solutions are integrated into the entire process and are not concentrated on individual machines.”
In order to achieve these high levels of operator safety and efficiency you have to be able to realize a containment strategy for the complete production line, including coordinated sub-processes and interfaces. The Excellence United partners have been established pioneers in the market for integrated containment solutions since the mid-1990s. The alliance enables the partners to pool their individual expertise and experience in containment. This pooled competence offers drug manufacturers access to efficient continuous and batch processes. All the production steps are performed in compliance with GMP guidelines and satisfy toxicological limits. This is how Excellence United creates the basis for seamless contamination-free production. The alliance covers the entire manufacturing process including packaging.
“In sessions sometimes lasting several days and ranging from setup to troubleshooting to cleaning, we go through every conceivable process step with our customers,” Bernhard Brugger, asepsis and containment expert at Harro Höfliger, explains the procedure for a joint containment project.
Containment equipment versus protective overalls
The specific containment requirements can already be analyzed accurately before selecting equipment. This includes a risk evaluation and an analysis of the relevant production parameters: above all, toxicological values, frequency of production cycles and the determined level of operator protection. “The results of these analyses can vary very considerably,” reports Michael Maintok, containment expert at Glatt. “At first glance, for example, personal protective gear often seems the most favorable option. Under certain circumstances, however, a high-containment machine can be the more economical solution.” The relevant analysis result ensures reproducibility, and validated processes rule out operator error to the greatest possible extent. According to GMP guidelines, among other things, this prevents cross-contamination to protect the product. In any event, an individual containment solution demands a high level of consulting know-how, underscored by a large number of completed projects. And this is precisely what the pooled competence of Excellence United offers.