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Microchem S.r.l - Products/Services - Contract Manufacturing Suppliers / Companies  Microchem S.r.l - Products/Services - Contract Manufacturing Suppliers / Companies

Pharmaceutical Products & Services Pharmaceutical Products & Services

 

Contract Micronization Services

At MICROCHEM the micronization process is performed in various MC JetmillŪ, Fluid Jet Mill which do not require mechanical machine components.

Fluid Jet Mill use the operating principle of planned acceleration and particle to particle impact. The Fluid Jet Milling process eliminates concerns with heat of friction from mechanical actions and associated mechanical movement concerns.

With Fluid Jet Milling, the particle size reduction of a bulk API or BPC powder is achieved through acceleration of the individual particles using a fluid stream of compressed air or pure nitrogen.

With this method, we create a controlled environment for the particle size reduction. The fluid gases are filtered before use and after exiting the Fluid Jet Mill.

The Fluid Jet Milling performed by MICROCHEM is particularly recommended for materials which need particle sizes below than 100 microns and where particular particle size distributions are required.


Notable Features and Service Capabilities

Demonstrated compliance with current Good Manufacturing Practices (cGMP). Demonstrated compliance with current Good Manufacturing Practices (cGMP).
Proven expertise in process development for Fluid Jet Mill particle reduction. Proven expertise in process development for Fluid Jet Mill particle reduction.
Facility and equipment design to prevent cross-contamination; Facility and equipment design to prevent cross-contamination;
Independent working cabins [processing suites] for controlled environments; Independent working cabins [processing suites] for controlled environments;
Completely independent air-handling systems with dedicated HEPA air-filtration for each cabin; Completely independent air-handling systems with dedicated HEPA air-filtration for each cabin;
Cabins and equipment engineered for complete cleaning, rapid assembly and increased productivity. Cabins and equipment engineered for complete cleaning, rapid assembly and increased productivity.
Equipment designed to conserve product and give high yields (low process loss). Equipment designed to conserve product and give high yields (low process loss).
Milling equipment and contract service available from R&D or laboratory scale up to large volume commercial production. Milling equipment and contract service available from R&D or laboratory scale up to large volume commercial production.
Our equipment, MC Jetmill®, used exclusively. Our equipment, MC JetmillŪ, used exclusively.
All compressed process fluids are filtered and monitored. All compressed process fluids are filtered and monitored.
Specialty micronization capabilities available: Specialty micronization capabilities available:

Steroidal compounds handled in dedicated process cabin and equipment;

Inert gas [Nitrogen] micronization for Explosive or Oxygen sensitive compounds;
Full Quality Assurance and Control; Full Quality Assurance and Control;

Rigorous particle size measurement and/or distribution analysis using Laser Analyzers;

Complete traceability of all materials.
Qualified technicians and highly trained personnel perform process operations and provide technical support. Qualified technicians and highly trained personnel perform process operations and provide technical support.

MICROCHEM is ISO certified for Quality [ISO 9001:2000] and Environment [ISO 14001:1996] for Integrated Management System, and FDA accepted.

Microchem Labs
Microchem Labs

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Address

Microchem S.r.l Microchem S.r.l
  Via Turati, 2 - 29017
  Fiorenzuola d'Arda (PC)
  Italy
Tel. +39-0523.981.130
Fax +39-0523.942.935

Microchem Cabins
Microchem Cabins

  
 
 
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