How to Scale-Up from Lab to Pilot to Production

 

How to Scale-Up from Lab to Pilot to Production

It is one thing to get a pharmaceutical product to perform well in the lab and another thing to get the same result to scale up flawlessly in the production stage. In addition, factors such as altered material properties and different batch sizes can impact the performance of products.

The pilot scale-up technique is helpful to scientists, as it can help them to understand the ultimate potential of a product. In addition, because it can come in handy to know the pitfalls to avoid, we have provided a pathway to follow during this process. Keep reading to learn more about this.

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Pilot Scale-Up and the Processes Involved

The pilot scale-up process explains the procedures involved when developing products before formulating the first pilot-production batch. Below, we have highlighted the four primary steps to follow.

1. Choosing the formula

The first step in pilot scale-up in a pharmaceutical formulation is to choose an appropriate preliminary formula. This process will be completed in the development laboratory. Your selected formula should be one you intend to test and know more about based on factors such as initial specifications and design requirements. This formula should be referred to as your (1x) laboratory batch.

In many cases, the initial size of the laboratory batch will be:

* 3 to 10 kg of a semisolid/solid

* 3 to 10 liquid liters

* 3,000 to 10,000 capsule or tablet units

Before creating capsule or tablet units, milling must occur. During this process, the material is broken down into more uniform and smaller particles. After that, developers can compress, mix, compress, and coat the particles into the final unit dosage.

2. Creating the laboratory pilot batch of the drug product

The second step is to make a laboratory pilot batch. This batch will be (10x). Because you are multiplying your first batch by 10 to get a larger scale, your pilot laboratory batch will be:

* 30 to 100 kg of a semisolid/solid

* 30 to 100 liquid liters

* 30,000 to 100,000 capsule or tablet units

Bear in mind that these numbers are not a concrete rule but a standard. In addition, a few factors, such as the cost of your raw materials and the availability of your essential equipment, can alter your laboratory pilot batch.

3. Carrying out Stability Testing

Now that you have prepared pilot laboratory batches and instituted the process demonstration, the third step is to test advanced stability.

During this time, your product should be in its approved packaging instead of standard packaging.

4. Ongoing Pilot Production

The last and final stage is the pilot production phase. During this phase, the batch will scale up to 100x. This means that the batch will become:

* 300 to 1,000 kg of a semisolid/solid

* 300 to 1,000 liquid liters

* 300,000 to 1 million capsule or tablet units

At the end of this phase, the product passes through stability testing in approved packaging.

Sovereign Pharmaceuticals is a pharmaceutical company in Texas. We constantly upgrade our facilities and equipment to meet our customers’ demands. We request you to visit our facilities and are open to the opportunity to talk about how we can meet your production and development needs. Contact us today.