Tradichem creates the first in the world GMP sites for API compaction and granulation with the cutting edge Hipering technology

Tradichem SL creates the first in the world GMP sites for API compaction and granulation with the cutting edge Hipering technology

The GMP site , also know as TIS, is running since November 2017. TIS has been GMP recertified in 2020. The assembly, design and performance of the Clean rooms at Arganda del Rey facilities has been carried out by MONTAJES DELSAZ.

APIs physical processing is a regular activity in the pharmaceutical industry. After synthesis or fermentation processes for obtaining APIs, most of these APIs requires compaction and granulation stages to be adapted to every final dosage form (FDF) and equipments

Many more of the APIs need to be pre-compacted at FDFs manufacturing sites with nonspecific equipments. This missuse is translated into the increase of material costs, higher dedication of employees, decrease of yields, longer manufacturing time and further related costs due to this API pre-processing.

Because of this technological challenge, Tradichem has created the most cost effective technology, (Hipering) for diminishing the bath to batch API variability, of the customers, and achieving the physical standardization of pharmaceutical actives that eliminate the costly and inefficient stages of APIs pre-compaction.

Hipering technology is a continuous dry process with lack of excipients, where the API is physically modified to improve critical parameters in the manufacture of FDFs such as fluidity, bulk density, particle size, homogeneity, volatility and hygroscopicity. The AEMPS certified GMP site is located at Arganda del Rey, Madrid.

MONTAJES DELSAZ performed the design and construction of the Clean rooms and QUALIPHARMA carry out the continuous equipment/processes qualification.

The double facility for the processing of API and nutraceutical ingredients is owned by Tradichem Industrial Services. TIS is a fully dedicated site with experienced technicians and fully dedicated equipments to the raw materials physical processing of third parties.

Hipering technology used is the most cost/efficient existing technology in the pharmaceutical industry and the results obtained are far from similar existing processes.

Hipering technology is the result of the Tradichem Industrial Services know how. The technology has been granted with 3 patents and offers to the suppliers of pharmaceutical nutraceutical ingredients the possibility of supplying batches with minimum variability, uniform PSD, custom made bulk density and an optimum industrial behavior as never ever before.

Hipering patented technology offers to the FDF manufacturers APISn extremely efficient specifically adapted to their equipment train and industrial processes. This high efficient APIs removes manufacturing stops, decrease production timings and a overall 60/70% of reduction in the industrial costs.

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