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Projects in the GMP-Regulated Environment

Tehranil Pharmaceutical Co., Tehran - Iran

Design Review - Tehranil Pharmaceutical Factory

PROCESS.ING LifeSciences GmbH as external consultants is authorized to verify GMP conformity of the Design, which was prepared by Tehranil Pharmaceutical Co. Under consideration of specific requirements for the production of solid antibiotics a Design Review was executed. The preliminary result was the performance of a Design Review Report providing recommendations for measures to be introduced. A final Review shall establish documented evidence that GMP conformity was achieved within the Design for Tehranil Pharmaceutical Factory.

Loxxess Pharma GmbH, Regensburg

Cold Storage 2.0° C - 8.0° C

Loxxess Pharma GmbH builds a cold storage for the GMP compliant storage of pharmaceuticals, bulks and active pharmaceutical ingredients and excipients in their distribution centre at the Regensburg location.

PROCESS.ING LifeSciences as the general contractor is charged with the design, realization and commissioning through to qualification and validation of the cold storage.

Darou Pakhsh Pharmaceutical Mfg. Co., Tehran - Iran

Small Volume Parenterals in Vials

Darou Pakhsh Pharmaceutical Mfg. Co. is Iran's leading manufacturer, distributor, importer and exporter of medical and pharmaceutical base stocks, operating the largest R&D centre in Iran. Darou Pakhsh is planning the realization and validation of a drug manufacturing facility for the production of sterile pharmaceuticals in Tehran, Iran.

Darou Pakhsh realizes the manufacturing facility as a multi purpose plant for the production of Small Volume Parenterals which includes 5 production modules:

As a general contractor, PROCESS.ING LifeSciences Group is assigned with the Design, Build and Validation as well the management of the interfaces and coordination.

Loxxess Pharma GmbH, Regensburg/Wolfratshausen

"Excellent cooperation and coordination in conjunction with the high quality of implementation have led us to a new GMP standard."

Warehouse management system

Room monitoring system

Vetter Pharma Fertigung GmbH & Co. KG, Ravensburg

"Excellent coordination and subcontractor selection have helped us recover major schedule slippage and meet the project milestones and final completion date. Excellent technical and methodology competence which is rare to find on the market."

Reference data sheet: "Construction, Commissioning, Qualification and Validation of Building Services Systems RVS AS1" (PDF).

Award: Vetter wins Facility of the Year Award in the category "Process Innovation" - a huge success for the customer PROCESS.ING LifeSciences Group (formerly AXI-TECH Gmbh).

Darou Pakhsh Pharmaceutical Mfg. Co., Tehran - Iran

Large Biopharmaceutical Project

Darou Pakhsh is planning a manufacturing facility for the production of biopharmaceuticals as well as the production of solutions suitable for injection. The project scope includes fermentation, down-stream processing, compounding as well as fill and finish of dosage forms. As a general contractor, PROCESS.ING LifeSciences Group is assigned with the GMP coordination.

The realization of the project will make a major contribution towards expanding the capacity and boosting the quality standard of drug production in Iran based on international health sector guidelines, standards and methods, GMP standards and FDA regulations.

Medium-sized German pharmaceuticals manufacturer, Germany

Reference data sheet: "Design of a Fed-Batch Fermentation Plant complete with Downstream Processing Facilities for the Commercial-Scale Synthesis of Peptide Antibiotics" (PDF).

Lonza Group, Switzerland

Reference data sheet: "Design and Construction of a Multi-Purpose Biotech Facility for API Production in a cGMP Environment". (PDF).

Intervet International GmbH, Munich

"Thanks to the optimum plant design, we have been able to significantly increase our yield per campaign which, at 11,000 injectors per hour, is well above our most ambitious expectations."

Reference data sheet: "Race for cpk 1,33 - Process Development and Optimization of an Aseptic Preparation and Filling Facility for Single-Use Injection Preparations" (PDF).

sanofi aventis Deutschland GmbH, Frankfurt am Main

"Excellent cooperation even in difficult project phases."

Reference data sheet: "Construction of a Pharmaceutical Facility for the Production of Sterile Liquids." (PDF).

Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach/Riss

"It has been worthwhile for Boehringer to select the industry's top performer for the project."

Reference data sheet: "Qualification and Validation of the Process Plants at the New Production Plant H122 Biberach a. d. Riss location" (PDF).

Reference data sheet: "Qualification and Validation of Technical Building Services at the New Production Plant H122 at Biberach a. d. Riss location" (PDF).

Roche, Grenzach

Further Projects

Download: Projects (PDF)

PROCESS.ING Life Sciences GmbH

Hanauer Landstraße 328-330
D-60314 Frankfurt am Main
Fon: +49 (0) 69 - 710 448 7 - 0
Fax: +49 (0) 69 - 710 448 7 - 19
Email: helen.kuehn@processing-lifesciences.de