Differences between the Laboratory Pilot and Commercial Scale
There are three different types of scale of operation in pharmaceutical manufacturing. Let us explore the differences between each of these scales. Laboratory scale means production is in small quantities, whereas pilot scale ensures relatively large quantities than laboratory scale, yet relatively small in scale compared to commercial scale.
In Laboratory scale production is small. Pilot Scale relatively large than laboratory scale yet relatively small to commercial scale.
Laboratory Scale:
In the initial stages, a pharmaceutical company’s scientists and researchers develop a new medication, which may include tablet formulations, in the laboratory. These formulations are tested in small quantities to determine their efficacy and safety.
Pilot Scale:
After successful formulation development, the process moves to a pilot-scale production phase. In this stage, the tablet production process is optimized for larger quantities, but it is still relatively small in scale compared to full commercial production. This helps in refining the manufacturing process and addressing any issues that arise during scale-up.
The formulation is tested in larger batches, and adjustments are made to ensure product consistency and quality.
Commercial Scale:
Once the formulation and production process are well-established and optimized at the pilot scale, the pharmaceutical company transitions to full-scale commercial manufacturing.
The tablet manufacturing facility is equipped with larger equipment, capable of producing tablets in much greater quantities.
Quality control measures, such as in-process testing and finished product testing, are carried out to verify that the tablets meet all quality and safety standards.
For example, let’s consider a hypothetical medication called “Amlodipine 5mg Tablet” for hypertension. In the laboratory, researchers may develop a small batch of Amlodipine 5mg Tablets and test them for efficacy and safety. If the results are promising, the formulation moves to the pilot plant, where the manufacturing process is optimized for a larger production batch. The tablets are produced in larger quantities to ensure consistent quality.
Once the tablet manufacturing process is perfected at the pilot scale and meets regulatory requirements, the pharmaceutical company can then move to full-scale commercial production. This might involve producing millions of Amlodipine 5mg Tablets, which are distributed to patients and healthcare providers.
Throughout this scale-up process, the pharmaceutical company must ensure that the tablet’s formulation remains consistent, the production process is robust, and the tablets meet regulatory standards for safety, efficacy, and quality. The manufacturing facility, equipment, and quality control measures are adapted to accommodate the larger-scale production.
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