Small batches and large-scale production: Flexible packaging infrastructures for different batch sizes

The requirements for pharmaceutical secondary packaging are based on the applicable European quality and regulatory standards. Differences in labelling, packaging design and other product-specific characteristics arise in particular from the properties of the respective medicinal product and the requirements of the respective destination country.

In addition to established medicinal products produced in high volumes, smaller batches are also processed, for example for clinical trials, specialised therapeutics or products with initially limited market volume. These varying batch sizes require appropriately tailored packaging processes and capacity concepts.

This also means that customer-specific requirements for packaging lines are changing. Whilst large-scale production runs benefit from automated processes and high throughput rates, smaller batch sizes often require a different combination of format flexibility, changeover capability and process control.

A suitable packaging infrastructure should therefore be able to accommodate different batch sizes within defined GxP and quality processes.

Different batch sizes, different requirements

Packaging lines are usually designed for recurring formats and larger production volumes. However, when product configuration, batch size, country-specific regulations or market requirements change, flexible processes become much more important.

For smaller batches, the following factors may be particularly relevant:

• Changeover times: Frequent format changes increase the organisational and technical workload.
• Start-up and material losses: With small batches, rejects and start-up material can account for a larger proportion of the total volume.
• Format diversity: Different primary containers, pack sizes and country-specific requirements call for correspondingly flexible processes.
• Scalability: Processes from clinical or early project phases may develop into larger commercial volumes later in the product life cycle.

The design of a packaging line must therefore not be geared exclusively towards maximum speed in terms of output per unit. Equally important are the ability to change over, reproducible process sequences and the capability to process different product configurations within a standardised environment.

Modular plant technology for varying production volumes

At Complex Pharmaceuticals’ site in Traiskirchen, a modular plant structure is planned which can accommodate different packaging requirements and batch sizes.

Format changes and set-up times

With a wide variety of products and formats, set-up and start-up processes are a key part of production planning. Modular changeover components and standardised process parameters can help to make format changes more structured and reduce the necessary changeover times.

Depending on the packaging configuration, different formats and dosage forms can be accommodated, such as blisters, vials, bottles or more complex kit configurations.

It is not just the technical speed of a format change that is crucial. Equally relevant are the subsequent set-up, process control and documented approval for further production.

From clinical batches to commercial supply

Another aspect of flexible packaging structures lies in the development of a product across various phases. Between clinical development, regulatory approval and commercial market supply, batch sizes, packaging configurations and country-specific requirements may change.

Taking these differences into account at an early stage can support subsequent production planning.

The following points may be particularly relevant in this regard:

1. Smaller batches and trial material: Packaging processes can be tailored to the respective quantities and product specifications.
2. Scaling of production volumes: As demand increases, production and packaging capacities can be adjusted in line with the planned market supply.
3. Country-specific packaging requirements: Language variants, package inserts, labelling and serialisation can be integrated into the respective packaging planning depending on the target market.
4. Continuity of quality processes: Even with varying batch sizes, documented process flows, in-process controls and quality-related requirements always remain central components of the packaging process.

Conclusion

Smaller batches and large-scale commercial production place different demands on secondary packaging. Whilst the level of automation and throughput are more important for larger volumes, flexibility, the ability to change over quickly and coordinated process planning become more significant for smaller batch sizes.

Particularly with smaller batches, the time spent on set-up, format changes and process preparation can account for a larger proportion of the total production time. As these activities are sometimes incurred regardless of the number of units produced, this can affect the cost-effectiveness of small batch sizes. Flexible plant designs and efficiently organised changeover processes can help to better adapt the preparatory effort to different batch sizes.

A packaging infrastructure designed accordingly can thus help to accommodate different product volumes within a GxP-compliant process environment and to plan capacities throughout the product life cycle in line with demand.

For contract manufacturing clients, this provides an additional option to manage packaging processes ranging from smaller project and trial batches right through to commercial production volumes within a coordinated infrastructure.

Are you planning smaller batches, clinical packaging projects or commercial production volumes?

Whether it’s clinical trial supplies or large-scale commercial production for 2027: speak to our team about your specific batch sizes