All About Pilot Plant Scale-up Techniques

Pilot plant scale-up is a branch of the pharma companies in which a lab-scale formula is converted into a commercially viable product by creating a reliable manufacturing technique. The same techniques employed in dosage form Research and Development are adapted to multiple output volumes, frequently larger than those obtained during Research and Development. There is always a requirement for an intermediate batch scale describing techniques and imitating those in commercial manufacturing in any new or established pharmaceutical sector. This is accomplished by testing the formula’s ability to survive batch-scale and process changes.

Objectives of Pilot Plant Scale-Up Techniques:

• A plant is a location where the 5 M’s (money, material, man, method, and machine) are joined together for product manufacturing.
• A pilot plant is a facility in the pharmaceutical business that converts a lab-scale formula into a commercial product by developing a reliable and practical manufacturing technique.
• Scale-up is the process of creating a prototype utilising data gathered from a pilot plant model. R&D Production Pilot Plant is a term used to describe a research and development facility.

Formulation scientists and production managers would be interested in pilot plant scale-up from the beginning of a development project. Even after producing an excellent product in the laboratory and, therefore, the pilot plant, a well-defined procedure may fail quality assurance tests at a full manufacturing scale. For a pilot plant scale-up to be successful, a product must be able to be processed on a large scale, frequently with equipment that merely matches those used in the development laboratory.

The Importance of pilot plant scale-up

• Formulae are examined.
• Examining a variety of related processing equipment.
• Adjusting the production rate. A physical space concept is necessary.
• Appropriate records and reports are required to support GMP.
• Essential features must be identified to ensure quality.

Steps in Pilot plant scale-up techniques:

Laboratory batch

• Choosing an appropriate preliminary formula.
• The task is carried out in the development lab.

• Batch (1X).
  • 3 to 5 kg of solid or semisolid matter
  • liquids ranging from 3 to 5 litres
  • 3000 to 5000 tablet/capsule units

Laboratory pilot batch

• Batch (10X).
  • 30 to 50 kg of solid or semisolid matter
  • liquids ranging from 30 to 50 litres
  • 30,000 to 50,000 tablet/capsule units
•  Depending on size may vary.
•  Availability of equipment.
•  Availability of active drug substances.
• Raw material costs.
• Inventory needs for clinical and non-clinical research

Pilot production

• Work is done by combining the development laboratory and the manufacturing unit.
• In standard production equipment, this represents a whole production batch.
• Batch (100x)
  • 300 to 500 kg of solid or semisolid matter
  • liquids ranging from 300 to 500 litres
  • 300,000 to 500,000 tablet/capsule units

Pilot plant scale-up considerations for solids:

Pharmaceutical medicine preparations in the shape of tablets, capsules, powders, granules, lozenges, and suppositories are classified as solid dosage forms. Understanding the Pilot plant scale-up techniques used in pharmaceutical manufacturing would help with Pilot plant scale-up considerations for solids.

• Material handling system: Material management is critical in large-scale manufacturing. Vacuum loading systems, devices to raise and tilt drums, metering pumps, and screw feed systems are examples of different material handling systems. The properties of the materials determine the sort of system chosen.
• Dry blending: Granulated powders must be well mixed to ensure appropriate medication distribution. An unequal percentage of the batch could arise from insufficient powder blending. Before mixing, take the necessary procedures to guarantee that all components are rid of lumps and agglomerates.
• Granulometry: The procedure entails converting tiny powders into free-flowing powders that are extremely easy to compress.
• Binders are used to make powders more compressible and resistant to breaking during handling in tablet formulations.
• The drying process: Granulation is dried in a circulating hot air oven heated either by steam or electricity. Drying times at specific temperatures and airflow rates must be considered for each product.
• Slugging (Dry granulation): The slugging forces, the diameter of the punches, and the size and screening operations should all be considered. Particle size and distribution are affected by optimising these factors.
• Compression: The method compresses granulation on a high-speed tablet press to form tablets.
• Coating for Tablets: The granulation of a tablet formulation can be tested using a high-speed tablet press to see if it can be compressed.
• Stability and quality control: There are additional spaces for performing the following tasks. Research on stability.Stability studies at a faster pace. Studies on accelerated light stability. Investigations of forced deterioration in compliance with ICH recommendations.

Conclusion:

Scale-up runs are easily visible to personnel of the production and quality control divisions. After being cleared by the quality control division, excipients and medications can be obtained from the production division’s more expansive locations. Engineering department specialists are available for equipment installation, maintenance, and repair. The frequency of direct interaction between the formulator and the production people in the manufacturing area will be minimised. Any manufacturing issues will be directed to the people at the pilot plant.