JETPHARMA

Micronisation of APIs, Excipients, Steroids, Cytotoxics and Cytostatics, HPAIs, and Antibiotics

Contract micronisation services

JETPHARMA is a supplier of contract micronisation services to the pharmaceutical industry.

Founded in the early 1960s by Alberto Martinoli, the company has developed a reputation for outstanding micronisation competence and excellent service levels.

Over the decades, the company has built up the following qualities:

  • A loyal and frequent customer base
  • The development of expertise in research and development (R&D) tests and in the manufacture of industrial quantities of various products: active pharmaceutical ingredients (API), inert substances, highly potent active ingredients (HPAI), cytotoxic and cytostatic drugs, steroids, and psychotropic substances
  • Ever-increasing micronization yields
  • Ever-decreasing particle sizes, down to fractions of a micron

JETPHARMA is able to offer excellent scalability, with the ability to maintain the same granulometric curve at ever-increasing production capacities.

Using a series of modular machines, the company can manufacture single gram quantities up to hundreds of kilograms, whilst retaining the same granulometry and performance.

Fully contained micronisation services

JETPHARMA provides a range of services for micronisation that needs to be contained:

  • Complete avoidance of cross-contamination and mix-ups
  • No release of hazardous substances into the environment
  • Full respect for the active ingredient, operators and the surrounding area

In addition to the GloveBox isolator, JETPHARA's Half-Suite box isolator enables the company to offer:

  • High containment below 50ng/m³ - third-party verified
  • Wide handling operations, packaging up to 120l
  • Quick lead times and fast operations
  • Different types and sizes of mill, enabling milling flexibility
  • Different activities with total containment: jet milling, sieving, pin milling, power spectral density (PSD) analyses
  • Cleanroom: class 100,000
  • Half-Suite box isolator: class 10,000

Quality micronisation services

JETPHARMA's quality is demonstrated through the loyalty of its customers, many of who have continued to use the company's services for decades. This loyalty enables long-term partnerships and has allowed the company to offer Swiss quality at European prices.

Strong regulatory success

JETPHARMA has built an excellent reputation with regulatory authorities, and has a highly successful inspection history, including:

  • Regularly inspected by Swissmedic
  • US Food and Drug Administration (FDA) inspected pre-approval and good manufacturing practices (GMP)
  • Inspected by Korea Food and Drug Administration (KFDA)

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

JETPHARMA's service range includes the following:

  • Micronisation of APIs, steroids, cytotoxics and cytostatics, HPAIs, antibiotics (not B-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 point with 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 also available for highly sensitive products, as it avoids polymorphic changes and an increase in amorphous particles, enabling the micronisation of polymers

Laboratory activities for quality control

JETPHARMA also offers a range of laboratory services for quality control purposes. These include:

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

Laboratory instruments for quality control

To ensure exceptional levels of quality control, JETPHARMA has an extensive range of advanced laboratory instruments and equipment. These include:

  • Malvern Mastersizer microplus (wet dispersion only)
  • Malvern Mastersizer 3000 (wet and dry dispersion)
  • Fourier transform infrared (FT-IR)
  • Melting point analyser
  • Ultra Vioet (UV) visual spectrophotometer
  • Air sampler for microbiological analysis
  • Air sampler for environment hygiene control
  • Optical microscope with image analysis

Validation services for regulatory compliance

To ensure complete regulatory compliance, JETPHARMA undertakes a range of validation activities. These include:

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

To find out more about JETPHARMA's range of services, or to make an enquiry, please contact us using the details below.

Contact Details

JETPHARMA SA 

Via Sottobisio 42a/c
P.O. Box 234
CH-6828 Balerna 

Switzerland
+41 91 696 10 10 

+41 91 696 10 30
contact@jetpharma.com
sales@jetpharma.com
total.containment@jetpharma.com
www.jetpharma.com
www.micronization.com

Available White Papers

Download

State of Art in Micronisation 17 March 2016 The real added value when managing the micronisation process of an API is the experience acquired in the field.

Download

Micronisation and Milling Services 15 March 2016 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.

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