Pharmaceutical Contract Processing

Pharmaceutical contract manufacturing is when a drug manufacturer or formulator partners with a specialist third-party provider to carry out specific processing steps on their behalf, using the provider’s equipment, expertise and compliant facilities.

We offer a range of size reduction and powder characterisation services for the pharmaceutical industry, including milling, micronising, Mechanofusion™, classification and blending. Our team will work with you to identify the most appropriate process for your compound and specification requirements.

Our facilities and processes operate in accordance with Good Manufacturing Practice guidelines, ensuring that all pharmaceutical processing is carried out within a controlled, compliant and fully documented environment.

Responsibility is shared between both parties. Hosokawa Micron is responsible for operating GMP standards and agreed quality specifications, while the client retains responsibility for ensuring the contracted process meets the wider regulatory requirements for their product.

Please contact our team to discuss your specific material requirements. We will assess the suitability of your compound against our facility capabilities and safety protocols before any processing begins.

We operate with defined and validated processing parameters, with full documentation and traceability maintained throughout each production run. This ensures that every batch meets your agreed specifications consistently and reliably.

Yes. We work with pharmaceutical businesses at every stage, from small-scale feasibility trials and formulation development through to full commercial production volumes, providing a flexible service that grows with your requirements.

We follow strict cleaning and changeover procedures between production runs, with documented verification to ensure there is no risk of cross-contamination between materials or batches.

We provide comprehensive batch documentation, processing records and certificates of conformance as standard. Our documentation processes are designed to support your own regulatory submissions and quality management requirements. Our equipment is fully validated for use over the minimum and maximum operating conditions.

We offer a range of secure packaging options, including sacks, drums, hermetically sealed vacuum foil, ensuring your processed materials are packaged safely, compliantly and in line with your specific requirements.

Contact our team with details of your compound, processing requirements and target specifications. We will guide you through the process, including any feasibility assessments or trials required before full production begins.

Our milling and classification technologies are capable of achieving a wide range of particle sizes, from coarse granules through to fine micronised powders. Our team will work with you to establish the target particle size distribution required for your formulation.

Micronisation is a size reduction process that produces very fine particles. It is commonly used in pharmaceutical manufacturing to improve the bioavailability, solubility and absorption of active pharmaceutical ingredients.

Equipment validation is carried out in accordance with GMP requirements, including installation qualification, operational qualification and performance qualification using surrogate materials. Full validation documentation is maintained and available to support your regulatory requirements.

Particle size distribution directly affects the performance of a pharmaceutical product, influencing dissolution rate, bioavailability, content uniformity and processability. Achieving a consistent and controlled particle size distribution is therefore critical to product efficacy and regulatory compliance.

We carry out a range of powder characterisation analyses, including particle size distribution, bulk and tapped density, and flowability. These measurements help establish baseline material properties and verify that processing has achieved the required specifications.

Certain pharmaceutical powders present handling challenges due to static charge or cohesive behaviour. Our team has experience managing these material characteristics and will select the most appropriate processing approach and equipment configuration to ensure reliable and consistent results.

Air classification is used to separate particles by size and density. In pharmaceutical processing, it is particularly useful for achieving tight particle size distributions and removing fines or oversized particles that could affect product performance.