MUnit, JETPHARMA, Microchem Micronisation of APIs, Excipients, Steroids, Cytotoxics, Cytostatics, HPAIs, and Antibiotics
JETPHARMA (JP) and MICROCHEM (MCH) provide contract micronisation services to the pharmaceutical industry.
Founded in the 1960s by Alberto Martinoli, the companies have built a loyal and frequent customer base in the industry, developing their expertise with active pharmaceutical ingredients (API), inert substances, highly potent active ingredients (HPAI), cytotoxic and cytostatic drugs, steroids, and psychotropic substances.
They have achieved ever-increasing micronisation yields and ever-decreasing particle sizes, down to fractions of a micron.
In 2016, JP and MCH’s commercial and technical expertise were concentrated into new consultancy company MUnit. The group has developed a reputation for outstanding micronisation competence and excellent service levels.
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.
Make an enquiry
MUnit, JETPHARMA, Microchem Images
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JETPHARMA
White Papers
Micronisation and Milling Services
In response to increased demand for new high profile services from the global market, JETPHARMA addressed to customers like a close partner, as if it were a spin-off of the client company.
State of Art in Micronisation
The real added value when managing the micronisation process of an API is the experience acquired in the field.
Related Projects
Press Release
MUnit has announced it will be showcasing its products at the Respiratory Drug Delivery (RDD) Conference at the JW Marriott in Tuscan, Arizona.
Read moreCPhI Japan is primarily a platform to establish new business relationships between European and Asian global pharmaceutical companies.
Read moreMunit has announced it will be participating as an exhibitor at the 4th Annual Formulation & Drug Delivery Congress in London, UK.
Read moreJP and MCH have announced they will be showcasing products at the 11th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology in Granada, Spain.
Read moreMUnit has announced it will be attending the 9th Global Drug Delivery & Formulation Summit in Berlin, Germany.
Read moreMUnit is glad to announce its participation in the forthcoming DCAT. The exhibition will take place in New York from 19 to 22 March 2018.
Read moreMUNIT has announced its commercial director Mr Schiavazzi will be attending PharmaChemOutsourcing at Long Branch, New Jersey.
Read moreJetpharma will be attending the 2nd Annual Formulation & Drug Delivery Congress in London, UK.
Read moreJetpharma will be attending the 10th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology from 4-7 April in Glasgow.
Read moreJetpharma's services continue to grow and the company is proud to announce a new range of services through the installation of Sympatec Helos BR.
Read moreJetpharma will attend CPhI Japan at the Big Sight Exhibition Center in Tokyo, Japan.
Read moreJetpharma has successfully installed a new pin mill within the Cytotoxic compounds facility.
Read moreRegional Offices
Via Sottobisio 42a/c
P.O. Box 234
CH-6828 Balerna
Switzerland
Via Turati 2
I-29017 Fiorenzuola d'Arda (PC)
Italy
