22 Scale-Up Expectations and Value
As you get ready to scale up, it is important to take a moment to discuss why scale-up is an important part of processing.
Objectives of Scale-Up
- Practice detailed planning before scale-up
- Experience with different, sometimes larger, equipment
- Produce samples for Home Use Tests, shelf-life/abuse testing, and final board meeting
Preparation Required
While the actual scale-up will only be one or two lab periods, it will take weeks to plan. A successful Processing section is tied to detailed and thorough planning. Your team must work through equipment selections, preventative controls, and scale-up planning documents including GMPS, SOPs, and a batch sheet. Testing industrial ingredients and new equipment also will need to be done resulting in a final industrial formula with specific processing parameters. It is also important to plan where and how to store your scaled-up product before you start.
One Chance
You are really only going to get one chance to scale up in the course, and you may only get once or twice to be able to scale up in a large processing facility, as well. This is especially the case if you have to stop the line or stop production of a day-to-day product to test run your new product. That time could be very limited so making sure all of the pre-work is done with attention to detail and potential problems or setbacks have been considered are critical to make that scale-up time count.
Product Samples Needed
The amount of product made during scale-up will be the amount needed for the Home Use Test, analytical testing, and shelf-life/product abuse testing. If your product has a 6-week shelf life or greater, more product will be made for the final board meeting and poster presentation. The amount needed for scale-up will vary based on the product but is typically still going to be a lab-scale amount. The goal is to make a bigger batch than what your team has previously made with equipment that has the same or very similar functions as the large-scale plant equipment.
Learning from Experience
Each time you go up in the size of equipment and each time you change the type of equipment and what controls you have over that equipment, your product characteristics have the potential to change. During scale-up it is likely that your team will not have as much processing control as with previous small batches. You will learn how that changes your product (possibly more waste, less uniformity, etc.). Most of the changes are not going to be significant, but some may be and it is important to know and understand these changes. For instance, if the moisture content of a cracker increases from 8% with small-scale processing to 12% with scale-up processing, the texture of the cracker could change significantly. A crisp cracker could become stale and tough with just this small moisture change. The processing parameters would have to be adjusted to produce an acceptable, lower moisture cracker. Knowing what characteristics are critical for your product will allow you to make quick changes while scaling up.
Here is a checklist of items that need to be completed and approved before you will be ready to scale up.
Scale-Up Preparation Checklist
- Large Equipment determined
- Small Equipment chosen (based on large equipment function) and tested
- Updated Flow Diagram approved
- Preventative Controls Hazard Analysis conducted and discussed with faculty
- GMPs approved
- SOPs approved
- Batch Sheet approved
- Industrial ingredients tested, industrial formula finalized
- New equipment tested (can be a small batch)
- Scale-Up Amount determined
- Time and Equipment scheduled
- Ingredients ordered and secured
- Storage of scaled-up product determined
To-Do List After Scale-Up
- Measure scaled-up product attributes to compare to the gold standard and to set final product specifications
- Write Home Use Test, get approval, send product out safely to consumers
- Start shelf-life and/or abuse testing
