Successful biocontainment strategies are holistic, with a focus on defining boundaries, training, careful logistics and consistent implementation.
Manufacturers can benefit from this alternative transfer technology that has now been adapted to solve issues in aseptic handling.
Most chamber mapping projects that fail do so because of inadequate preparation. Poor or inadequate preparation for the mapping study can lead to a failed mapping study, which can lead to unnecessary costs in valuable biopharmaceutical production time or regulatory and product quality issues.
Instead of comparing barrier systems solely in terms of investment costs, energy consumption offers another insightful approach – especially as it is in line with the recent trend towards green pharmaceutical manufacturing. Depending on ambient conditions, regulatory- and production-related parameters and the respective air supply systems, the energy consumption of Restricted Access Barrier Systems (RABS) and isolators varies significantly. For instance, isolator systems can save up to 65 percent of energy compared with RABS, while active RABS are up to 30 percent more energy-efficient than passive RABS.
This article discusses how to apply current isolation technologies with robotic systems to reduce the risk of microbial contamination in aseptic processes caused by human intervention.
An estimated 25 percent of globally manufactured drugs contain highly potent active pharmaceutical ingredients (HPAPIs). HPAPI drugs, which include small-molecule and biologic compounds as well as antibodydrug conjugates (ADCs), are often used in the treatment of cancer. The fastest growing segment of the HPAPI market are ADCs, a new class of therapeutic agents that deliver cytotoxic drugs selectively to antigen-expressing tumor cells. Non-oncology HPAPI compounds include hormones, narcotics, and retinoids.
At ILC Dover, we are always "creating what’s next" by listening carefully to our customers. In response to customer input and emerging regulations, we've developed a robust new film to support our DoverPac® Containment Solutions line. This revolutionary product, ArmorFlex® 110, delivers permanent static dissipative properties while meeting FDA and 2002/72/EC requirements for food contact.
The Drum Transfer System (DTS) described in this article has been validated in a variety of processes requiring the contained transfer of drummed materials in pharmaceutical applications. Processing operations described here include milling, subdividing, charging, and repackaging. Submitted by ILC Dover
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