FROM R&D TO PRODUCTION

Pharmaceutical Scale-Up Solutions

Scale your pharmaceutical production with confidence.

Moving from formulation development to larger-scale manufacturing requires more than increasing batch size.

Equipment capabilities, process behavior, material handling, and production controls must be considered together to support a repeatable manufacturing process.

Operator in cleanroom suit at a pilot rotary tablet press

Three Stages of Scale-Up

Unit ranges are illustrative, carried over from typical project discussions. They are not universal equipment limits; actual capacity depends on the formulation, equipment and process.

  1. 01 ILLUSTRATIVE · 10–1,000 UNITS
    Compact benchtop tablet press on a lab bench with powder and pressed tablets

    R&D Scale

    Develop and evaluate formulations using compact equipment designed for flexibility and small-batch experimentation.

    • Formulation screening and small trial batches
    • Material characterisation before process design
    • Benchtop equipment with fast changeover
  2. 02 ILLUSTRATIVE · 500–25,000 UNITS
    Operator at the touchscreen of a pilot pharmaceutical processing line

    Pilot Scale

    Translate laboratory processes into repeatable pilot operations while evaluating equipment performance and process requirements.

    • Repeatability and process-parameter studies
    • Equipment performance under realistic loads
    • Groundwork for larger-scale equipment selection
  3. 03 HIGHER THROUGHPUT
    Large cleanroom production floor with workstations and gowned operators

    Production Scale

    Plan for higher-throughput manufacturing with equipment and workflows suited to operational capacity and production goals.

    • Integrated lines and material flow
    • Capacity planning against production goals
    • Cleaning, changeover and operator workflow
THE PATH

From Formulation to Production

Scale-up is a sequence of decisions. Each stage informs the equipment and process choices of the next.

  1. 01

    Formulation and process evaluation

    Review the formulation, its material properties and the processing route it implies before committing to equipment.

  2. 02

    Equipment selection

    Identify equipment types and configurations that suit the dosage form, batch size and development stage.

  3. 03

    Pilot-scale development

    Run the process at an intermediate scale to observe how materials and equipment behave beyond the bench.

  4. 04

    Process optimization

    Adjust parameters and equipment settings to improve consistency and repeatability.

  5. 05

    Facility and workflow considerations

    Consider footprint, material and personnel movement, cleaning access and utilities alongside the equipment.

  6. 06

    Preparation for higher-throughput production

    Plan the transition to larger equipment and integrated workflows based on what pilot work has shown.

Equipment Selection Considerations

Dosage form

Tablets, capsules, semisolids and liquids follow different process routes and need different equipment families.

Batch size

Current and projected batch sizes determine equipment capacity and whether a scale step is needed.

Material properties

Flow, compressibility, particle size, viscosity and moisture sensitivity shape processing choices.

Process requirements

Mixing intensity, temperature control, containment and dosing accuracy narrow the suitable options.

Facility constraints

Available space, utilities, room classification and access for cleaning limit what can be installed.

Quality requirements

In-process testing, documentation and applicable regulatory expectations influence equipment configuration.

SCALE-UP PLANNING

Discuss Your Scale-Up Project

Tell us where your formulation is today and where production needs to go. We can help evaluate the equipment and process questions in between.