PILOT PLANT SCALE-UP PRODUCTION

Question 1

What is pilot plant scale up?

Answer 1

It is a small-scale test of the methods and procedures to be used on a larger scale.

It is a part of the pharmaceutical industry protocol where the same processes used during Research and Development (R&D) of dosage forms are
applied to different output volumes.

Question 2

Why should PPS be considered from the inception of a formulation development project?

Answer 2

This is because a process using the same type of equipment can perform quite differently when the size of the equipment and the amount of
material involved is significantly increased.

Question 3

What is the goal of PPS?

Answer 3

To assess the feasibility/acceptability of an approach to be used in a larger scale study.

Question 4

What is the rationale for pilot production?

Answer 4

1. It is a cost-effective needful manufacturing strategy for the avoidance
   of commercial and technical pitfalls of scaling the manufacturing process to large scale.
2. It is a bridging process of laboratory experimentation to large scale commercial manufacturing process.
3. It is also needed to safeguard the manufacturer investor from investment/economic risk.

Question 5

What are the uses of pilot scale process/production?

Answer 5

1. Pilot units are used to test the feasibility of manufacturing processes.
2. They help to define key parameters for process scale-up or even for a small production.
3. They are needed for the improvement/ upgrade /optimization of any existing process.

Question 6

What are issues of consideration in pilot scale production?

Answer 6

1. The chemical attributes of the product, its quality and efficacy should be maintained even though the production processes is modified as a result of sample size increase, and equipment changes.
2. A well-defined process may fail quality assurance tests in full manufacturing scale even after generating a perfect product in both the laboratory and the pilot plant.
3. Pilot plant scale-up,
   in itself, does not guarantee a smooth transition to larger scale production.
4. Calibration for adjustments to raw materials and process
   equipment is a necessary step in pilot scale production so that the product is safely and efficiently launched to market.

Question 7

What are the advantages of a pilot plant?

Answer 7

1. Collection of process data helps refine current processes for any future scale ups.
2. Testing of a commercial-grade materials

• Commercial grade equipment behave differently and, in most cases, require different materials of construction that are different from
  laboratory equipment.
• Testing these changes on a pilot scale, will reduce/avoid costly miscalculations on a production scale, while still enjoying a reasonable level of production.

3. Production of a minimum viable product

• A pilot plant can provide adequate quantities of useable product.
• The product from the pilot plant will determine the process viability and ROI for investors.
• Can be used to share samples with consumers to build a customer base, or / serves as a gateway to commence product sale.

4. Pilot plants can also be used to test formula changes on the existing formula or new product lines as the business continues to grow.

Question 8

What is the importance of a pilot scale?

Answer 8

1. It is crucial for making a product that works well and meets regulations.
2. Pilot production helps spot early bottlenecks and problems.
3. Finding issues early lets scientists, production teams, and quality controllers quickly fix them before scaling up.
4. It helps meet legal and compliance standards, so the company knows its future limits.
5. It checks the product’s chemical properties, quality, and effectiveness even when production changes.

Question 9

What are the protocols for consideration in pilot scale production?

Answer 9

1. Ensure raw materials that meet all the specifications are always available.
2. Decide the space and layout needed for both short- and long-term efficiency.
3. Check, confirm, and finalize all production and process controls.
4. Keep proper records and reports that support good manufacturing practices and document the production process.
5. Develop and confirm effective product reprocessing steps.
6. Identify key features of scaling up so each step is monitored and controlled as planned.
7. Set the production rate based on current and future market needs.
8. Understand the similarities between pilot and scale-up processes.
9. Troubleshoot early to fix scale-up issues before making big investments.
10. Test if the formula holds up when production is scaled up or modified.
11. Evaluate and validate equipment to meet the needs of mass production.
12. Make sure the product can be processed on large-scale equipment, even if it differs from lab equipment.