Flexibility in bulk-solids handling is an important trend in pharmaceutical manufacturing of active pharmaceutical ingredients and dosage forms, an issue addressed by Richard Denk, director of the pharmaceutical department for Hecht Anlagenbau (Pfaffenhofen/Ilm, Germany) at the conference session, “Disposable Containment Technologies for Bulk Solids,” at Interphex.
Flexible disposable technologies, such as flexible intermediate bulk containers (FIBCs), are becoming more common for handling products because of benefits in costs as well as providing an effective strategy for limiting operator exposure and product contamination, noted Denk. FIBCs can be filled and discharged with containment levels that previously could only be attained with the use of isolators. Another advantage of FIBCs is they do not have to be cleaned after use. Cleaning requirements are becoming more and more important, especially in multipurpose applications. For certain materials, such as steroids, hormones, cytotoxic, and teratogenic products, there is no cross-contamination or cross-mixing allowed. The cleaning validation of the packaging material for these types of bulk solids is very difficult. Flexible disposable technologies offer a cost-effective solution to address the problems, explained Denk.
What has been your company’s experience in using FIBCs in API or dosage-form manufacturing? Leave a comment below.