Rethinking API Manufacturing: Reducing Interfaces Through Integrated Processing

Sometimes improving a pharmaceutical manufacturing process is not about making an individual machine faster or more efficient.

It is about asking a different question: Does that machine need to remain a separate operation at all?

Looking Beyond Individual Unit Operations

API manufacturing traditionally consists of a series of separate unit operations, which can include:

• Reaction
• Filtration
• Washing
• Drying
• Milling
• Sieving
• Blending
• Product transfer

Each individual operation may be highly engineered and optimised for its specific purpose. However, every time a product moves from one piece of equipment to another, another interface is introduced into the process.

That transfer can bring additional handling requirements, cleaning considerations, operator involvement and potential containment challenges.

This raises an important engineering question:

Should we continue focusing solely on optimising individual machines, or should we also look at reducing the number of interfaces between them?

Moving Towards More Integrated API Processing

For conventional API manufacturing, reducing unnecessary transfers and interfaces can help create a more streamlined and efficient process.

For highly potent active pharmaceutical ingredients (HPAPIs), the advantages can become even more significant.

When processing potent or hazardous materials, every transfer and open operation needs to be carefully considered. Reducing the number of points at which operators, equipment and the product interact can support a more contained and controlled manufacturing environment.

Future API equipment development should therefore increasingly focus on:

• Fewer product transfers
• Fewer open operations
• Fewer product-contact interfaces
• Reduced operator intervention
• Improved containment
• More effective cleaning
• Greater integration between process stages

Rather than treating filtration, drying, milling, sieving and transfer as entirely independent stages, there is an opportunity to consider how equipment and containment systems can work together as part of a more integrated process.

Engineering the Process, Not Just the Machine

The objective is not simply to combine equipment for the sake of integration.

Every pharmaceutical process has different requirements, and factors including product characteristics, containment levels, cleaning requirements, production volumes and regulatory considerations must all inform the final equipment design.

The opportunity is to look at the complete manufacturing process and identify where unnecessary interfaces can be removed or better controlled.

At Schematic Engineering Industries, we design and manufacture equipment and containment solutions for API and bulk drug processing, supporting applications including sampling, dispensing, reactor charging, filtration, drying, milling, micronising, sieving, transfer and pack-off.

Explore our API Isolators and API processing solutions to discover equipment designed for different stages of API and bulk drug manufacturing.

You can also view our complete product range to explore Schematic's wider containment, process equipment and material handling solutions.

Discuss Your API Processing Requirements

Sometimes the next improvement in a pharmaceutical process is not a faster individual machine. It is a better-connected process with fewer unnecessary interfaces.

If you are reviewing an existing API manufacturing process or developing a new containment or processing solution, get in touch with the Schematic Engineering Industries team to discuss your requirements.