PharmTech: What are some of the key concerns with handling and packaging pharmaceutical powders?
Mitchell: There are numerous concerns that must be considered when handling pharmaceutical powders. Perhaps chief among these are separation of powder-based APIs and, closely related, protection of APIs from damage or degradation. Proper cleaning methods to protect against dust build-up and cross contamination also is a concern, as are humidity and environmental controls-especially if the particular product has microbial requirements. There are also issues to address regarding the equipment line. A particular product’s unique variables may determine or demand use or adaption of certain blending equipment and transfer systems.
PharmTech: What are some of the challenges that are being addressed as you expand your Union, MO manufacturing facility for ingestible powders?
Mitchell: We have upgraded the building to meet cGMP requirements and completed temperature mapping for the entire building. Construction on the pharmaceutical suite (Class 100,000) construction will start in April. The new filling line equipment is in the final stages of design, and we expect to begin installing these machines in the August/September timeframe. Validation activities will start in October/ November.
Thus far, the challenges have been primarily in the area of converting an existing building to cGMP status, and validating the HVAC systems. Installing a new high speed (100 BPM) line will bring PTI a whole new set of challenges yet to be determined. The desire of having one line, which can run multiple sizes, shapes, and provide quick changeover, makes the design phase the crucial element of this project.
PharmTech: What skills must operators have in handling and packaging pharmaceutical powders?
Mitchell: Operator training and certifications are essential for optimal performance and reliability. Past the stardard training materials, documents and initial training, PTI conducts regular evaluations of all trained staff. Once an employee is trained, a newly trained operator must be able to demonstrate the basic process and understanding of the job such as necessary knowledge, behavior, and skills to progress from trainee to operator. Here, we’re looking for heightened competence in a core set of skills and personality traits. Operators handling and packaging pharmaceutical powders must show a compliant attitude, the ability to follow instructions, and the patience to take the time to confirm that everything is completed correctly. In short, we need operators that focus on quality aspects as well as production.
About the Author
Melanie Sena is the Community Manager for Pharmaceutical Technology.