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Services

Micronisation
Micronisation is a proven technology of reducing the particle size of active pharmaceutical ingredients (API) for increasing the bioavailability of the products. The particle size reduction is accomplished through collission of the different particles in air or nitrogen stream. Lager particles are retained in the mill by centrifugal forces while smaller particles are carried out of the mill and are collected in an explosive-resistant collector system. In our facility we are equipped with state-of-the-art jet mills, so we are able to provide highest quality micronisation to the pharmaceutical industry. Micronisation is performed under cGMP conditions.

Technical Expertise
Our team includes management by professionals with long year experience in the pharmaceutical and API industry as well as experienced and trained employees.

Quality System Compliance
Our Quality Management System is fundamental to the business and ensures the provision of highest quality in production and services. We at Pharmycron Service GmbH are committed to meet and by far exceed our customers requirements through a well documented Quality Management Systems The company is operation according to cGMP and is in the process of certification according to ISO 9001:2000. We assure quality of our products by regularly inspecting the facilities, systems and procedures to meet the current GMP norms. The employees are trained periodically on GMP requirements. Our customers are invited to perform regulatory audits on procedures and processes.

QC and Laboratory Services
We provide complete product characterization and in-process QC using modern instrumentation. QC laboratories are fully equipped containing state-of-the-art equipment.
Through our network partners

we are able to offer the full package of analytical services for R&D oriented companies. These services include full analytical support, formulation support, preclinical testing as well as Regulatory Affairs and Quality Assurance Services.

Regulatory Support
We are able to provide assistance to our customers in the phase of preparing regulatory documentation for European and international submissions.

 

 
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