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Pharmaceutical manufacturing is an industry which is both exceptionally process-driven and heavily regulated. In the best-case scenario, one mistake in manufacturing can be expensive, and in the worst, it can endanger lives, particularly if a product has already reached consumers.
The industry must comply with various guidelines that have been set out by the Food & Drug Administration (FDA), for example, the Current Good Manufacturing Practices (cGMP). Product quality is at the core of cGMP, which ensures the appropriate monitoring, design and management of manufacturing facilities and processes.
In addition to the management systems and processes preferred for maintaining the best laboratory testing procedures, cGMP also gives guidance on how to acquire good-quality raw materials. All of the factors play a key role in the safety and success of pharmaceutical products.
Compliance with cGMP is a necessity for manufacturers, and while safety and quality are huge concerns in the pharmaceutical industry, these guidelines do expand the amount of challenges in the manufacturing process.
Accelerating processes and outputs without compromise
Results can be dramatically affected by even a minimal amount of contaminant, and the wide range of active pharmaceutical ingredients (APIs) employed means that verifying raw materials is a crucial step in the production process.
For the verification of materials, samples are typically sent to labs which are outside of the manufacturing floor to a team of highly trained professionals for analysis. This verification process is liable to bottlenecks and leads to frequent stoppages in production even though it is extremely accurate.
Difficulties occur when regulations demand the sampling of a statistical amount of containers for a delivered material (sqrt n+1), but the industry is moving in the direction of the verification of every single container of a delivered material (100 percent material verification).
Although it is a trusted technique, when utilizing 100 percent material verification to strengthen production safety it is vital to consider the size of delivery; this means that facilities may have to verify one drum or 1,000 drums per day.
The bottleneck issue which will be intensified by the collection of batches to test increasingly becoming time-consuming and labor-intensive which will be another obstacle later on in the production line.
Solvent drying is the partial or total removal of a solvent or solvents from an intermediate or API and it happens in a large range of process vessels, including tray dryers, vacuum dryers, and rotary dryers.
In the past testing the success of solvent drying could only be performed when the process was complete which also required outsourcing the testing of samples to an external or separate lab.
It was necessary for the product to re-enter the drying process if a test failed, which would lead to slow production times and the potentiality of over-drying the solvent, resulting in a lost batch.
It is no longer feasible to assign the testing of raw materials and drying samples to external or separate or laboratories because of the sheer number of test batches. Pharmaceutical manufacturers are looking for new tools which can accelerate the process of verification without compromising the accuracy of results.
Technologies rising to the challenge
Technological progress is currently being made in bringing the accuracy and power of the lab to the manufacturing floor. For instance, new spectroscopy technology is eliminating the requirement for facilitating raw material ID, wet chemistry testing, and other analyses to happen on the warehouse floor instead of a lab.
Those in charge of handling the inventory of raw materials and accepting shipments can test a sample quickly by utilizing a user-friendly, portable device for the verification of materials like ionic salts, including sodium chloride and potassium chloride, which are utilized extensively in buffers, injectables, and biologics.
In addition to accelerating raw material verification, analysis of the material in its original packaging means these tools also decrease the risk of cross-contamination and eliminate the requirement to transport the materials through various locations.
Process mass spectrometers can measure individual solvent concentrations in multiple dryer vents precisely and also monitor the drying process at a seperate location in the production line.
By having an advanced understanding of the emissions from APIs on the drying tray, manufacturers can now make fast alterations to temperature and heating durations.
Process mass spectrometers limit the risk of product loss from over-drying when they are utilized properly, and they can also speed up the production process while decreasing the dependence on time-consuming offline testing like Loss on Drying (LOD).
This online method significantly reduces interruptions to the process, enhances batch-to-batch quality, and shortens drying times.
Accelerating innovation through simplification
As is the case with many other industries, technological progress makes the pharmaceutical industry a more productive and much safer workplace.
Manufacturers are able to improve innovation and speed up production times with uncomplicated testing and analysis by assigning their highly technical staff towards R&D and decreasing the dependency on lab testing. The time of factory floor workers can also be better spent while maintaining compliance with cGMP and other regulations.
Produced from materials originally authored by O. Dean Stuart and Daniel Merriman from Thermo Fisher Scientific.
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