MUnit, JETPHARMA, Microchem

Fully contained micronisation services

JP and MCH provide a range of services for micronisation under containment to avoid cross-contamination and mix-ups, prevent the release of hazardous substances into the environment, and protect the active ingredients and operators.

JP’s Glove box and Half-Suite box isolators allow high-containment performance below 25ng/m³ (third party verified). Its flexible and dependable operations mean up to 120l of product can be handled and packaged quickly and efficiently.

The isolator can be used with different types and sizes of mill, handling a variety of activities including jet milling, sieving, pin milling, and particle size distribution (PSD) analysis.

High-performance, scalable micronisation solutions

JP and MCH offer excellent scalability, with the ability to maintain the same granulometric curve at ever-increasing production capacities.

Using a series of modular machines, the companies can micronize single gram quantities up to hundreds of kilograms, while retaining the same granulometry and performance.

Strong regulatory success

JP and MCH have built an excellent reputation with regulatory authorities, including:

• Swissmedic and European Medicines Authority (EMa), regularly inspected
• US Food and Drug Administration (FDA) inspected pre-approval and good manufacturing practices (GMP)
• Ministry of Health, Labor, and Welfare Japan (MHLW)

Mechanical milling services, de-lumping, API, excipient blending, and cryogenic micronisation

JP and MCH’s service range includes:

• Micronisation of APIs, steroids, cytotoxics and cytostatics, HPAIs, antibiotics (not Beta-lactams) with its spiral jet mills (MC JETMILL)
• Reduced product build-up and yields of more than 99% for the industrial process in quantities from 1kg upwards
• Very fine and precise particle size distribution with just a single micronisation passage for almost all pharmaceutical ingredients
• Micronisation of any pharmaceutical ingredients with no heat generation, even for those with a low (30°C – 40°C) melting poin, using isothermal jet mills
• Mechanical milling services with a hammer mill and micronisation with jet mills
• De-lumping, including the removal of agglomerates, can be achieved using spiral jet mills and a hammer mill
• Dispensing and re-packing of bulk APIs into any sized container in our cleanrooms and / or isolators
• Packaging under an inert atmosphere (nitrogen or argon) ensures API integrity through the preservation of powder
• Blending of excipients and APIs is available as a standalone process or as part of a wider micronisation process
• Sieving can also be provided as a standalone or combined process to achieve a specific particle size profile
• Co-micronisation, which combines blending and particle size reduction of an API and / or excipient, is also available as a single process
• Cryogenic micronisation is available for highly sensitive products, as it avoids polymorphic changes and an increase in amorphous particles; it is also enabling the micronisation of polymers

Laboratory activities and instruments for quality control

JP and MCH also offer a range of laboratory services for quality control purposes. These include:

• Identification analysis
• Cleaning validation studies
• Particle size distribution analysis
• Environment, water, and equipment surface microbiological monitoring
• Analytical method transfer
• Analytical method comparison study
• Contract laboratory for PSD analysis

To ensure exceptional levels of quality control, the companies also have an extensive range of advanced laboratory instruments and equipment. These include:

• Malvern Mastersizer Microplus (wet dispersion only)
• Malvern Mastersizer 3000 (wet and dry dispersion)
• Sympatec
• Fourier transform infrared (FT-IR)
• Melting point analyser
• Ultraviolet (UV) visual spectrophotometer
• Air sampler for microbiological analysis
• Air sampler for environment hygiene control
• Optical microscope with image analysis
• Validation services for regulatory compliance

In addition, JP and MCH undertake a range of validation activities. These include:

• Process parameter studies to define and support the validation activity
• Process validation
• Analytical method validation
• Analytical method correlation study

To find out more or to make an enquiry, please contact MUnit, which operates as a single access point to all of JP and MCH services.