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scaling up:
from concept to commission

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by Clarence Totleben
Plant Manager
APCO Packaging

A great idea is only as good as the final result. Getting there takes several steps.

The scale-up process in contract manufacturing begins with the client’s idea for a product (typically a powder or liquid formulation). It may be a new product, or an improvement on an existing one. But either way, it can usually be distilled down into a 4-step process to take it from concept to final commissioning.

Laboratory bench-top stage: ‘Eureka! (But will it work?)’
When a client comes to us with a new idea it may be in the conceptual stage, or as a formulation. It may never have been laboratory tested. Our project team produces a small (typically 1-kilogram) sample in the lab. The sample is tested and analyzed to see if it meets the client’s specifications, or it is used to help establish specifications. The goal is to get an effective formulation that is manufacturable.

Typical key elements to address when developing a successful formulation include the following:

  • Efficacy of the formulation
  • Chemical compatibility
  • Raw material and processing costs
  • Physical characteristics
  • Product stability
  • Optimize processing equipment efficiencies
  • If expectations are not met, then the refinement process continues.

Pilot stage: ‘Get ready…’
Once past the laboratory bench-top stage, we need to determine if the product can move through our equipment properly. We scale up from the lab sample to a larger (typically 20-kilogram) batch. Using equipment similar to the larger machinery used for a full batch, we run the sample, closely monitoring all the manufacturing parameters to determine if it is ready to scale up to a full-sized run.

Scale-up test batch: ‘Get Set…’
APCO prepares a production plan based on customer demand and sales forecasts. Processing equipment is selected which will meet these expectations. The actual production equipment and processes selected are validated to demonstrate their ability to achieve the planned results.

If necessary, we modify our equipment to ensure that it functions properly with the actual product formulation. We run a test on the complete process of blending, filling, sealing and packing the boxes for shipment.

Commissioning: ‘Go!’
If issues arose during any of the previous steps, by this time they would have been addressed, and any adjustments would have been made. All lab testing, QA inspection and manufacturing procedures will have been finalized. And all processing equipment will have been validated as appropriate to use. We’re ready to go!

Our first production run is closely monitored with the customer present. Significant observations, specified data, and QA/lab test results are collected and processed. All operational inputs and outputs are reviewed and approved by responsible personnel.

From that point on, we are confident in the repeatability of our manufacturing process; which equates to a product of consistent quality.

The entire process, from laboratory testing to the first commissioned run, can take anywhere from one to six months, depending on the complexity of the project. Once completed, the scale-up process guarantees that nothing has been left to guesswork, and the client, their customers and the consumer can count on quality products made efficiently and economically.

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