Eyeballing Quality Control in Pharmaceutical Manufacturing

Elsewhere in manufacturing, quality control consists of tasting, sampling, trying, and testing the products coming off the assembly line. In pharmaceuticals manufacturing, quality control is a bit more intricate. Prescription drugs consist of precise chemical compounds formulated to perform a certain task within the body. Quality control thus consists of testing not only the formula, but also ensuring that foreign materials don’t threaten the integrity of the medication. The product testing is performed by research and development. However, the product inspection for foreign materials is left to the quality control department.

Particle Infiltration

Foreign materials come from various sources to exist within the drug compounds. They are introduced in any part of the process, from production to packaging. Objects such as metal shavings and other items from the machinery (bearings, fibers, chips, dust, etc.) and well as additional ingredients can infiltrate. The compound is filtered as a part of the production and packaging process. The filter isn’t discarded. It is taken to the lab where the simple piece of material is turned into the key component of the quality control process.

Eyeing the Quality

The filter goes under a microscope, where it is analyzed for foreign materials. The particles are counted, each one identified and categorized. The oldest method is the manual counting method. The inspector actually eyeballs the particles to count and categorize them. This method is being left behind for semi automated and automated processes that are much faster, less prone to error and less expensive in the long run. However, companies turn to the human eye for counts on new products, new processes, or even new recounts after errors are found.

Other Concerns

Quality concerns in pharmaceuticals manufacturing also include calibration of the dispensing equipment. The equipment tends to lose its preciseness over time and must be recalibrated regularly. Sustaining things like temperature, oxygen levels, and overall drug stability throughout the production, packaging, and distribution processes is another concern. The compounds deteriorate over time. Drug companies must compensate for the deterioration that occurs before the patient takes it. This is both a research and development and a quality control concern.

Quality control is one of the most important parts of the pharmaceuticals manufacturing process. Like any other manufacturing plant, the proper preventive maintenance to the machinery can assist the quality control department in keeping the medications safe. Dispenser calibrations performed regularly are a part of that preventive maintenance as is upkeep of the automated and semi automated counters, microscopes, and other equipment in and around the plant.  At Eagle Technologies, quality control is of the utmost importance.

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