W. C. Heraeus GmbH, Germany
Heraeus - a product/project-related co-operation partner for Active Pharmaceutical Ingredients
The Company:
Heraeus, the precious metals and technology group headquartered in Hanau, Germany is a global private company in the business segments of precious metals, dental health, sensors, quartz glass and specialty light sources. With revenues of Euro 8,3 billion and over 9.800 employees in over 100 subsidiaries and associated companies, Heraeus has stood out for more than 150 years as one of the leading companies involved in precious metals and materials technology.
With the Heraeus group, W. C. Heraeus GmbH has extensive experience in the synthesis of highly potent Active Pharmaceutical Ingredients (APIs). Beside its traditional focus on generics the Business Unit Pharma seeks and maintains exclusive collaborations for the development and commercial production of New Chemical Entities.
Specific Strengths:
Manufacture according to cGMP guidelines, compliance with regulatory requirements and suitable documentation are matter of course. Our Business Unit is certified according to DIN EN ISO 9001 and approved by the FDA and German Health Authorities.
The existing production capabilities offered by Heraeus reflect the requirements for handling highly toxic compounds:
- Dedicated and multi-purpose equipment.
- Reaction volumes up to 630 l - completely housed for multi step synthesis.
- Gloveboxed equipment for handling of highly active cytotoxics.
- Completely gloveboxed reactor trains (up to 50 l) inclusive distillation and filtration units.
- Explosion-proof equipment.
- Temperature range for reactors from -25° to +140°C.
- Condensers from -25° to +60°C.
- Strict control of environment, equipment and staff to meet lowest OELs and to avoid cross contamination.
- Airlock systems to avoid pollution and cross contamination for all production units.
- Production possible in class 100.000 rooms.
- Treatment of highly toxic process gases, toxic liquid and solid waste.
- Standard OELs of 50 ng/m³ and below.
- Usage of sterile, pyrogen-free highly-purified water (according to EP) throughout all production steps.
- Electronic data recording throughout chemical development and routine production.
Further Valuable Information:
All business activities are based on a simple philosophy. Heraeus is a:
- reliable and international,
- fair and flexible,
- competitive, excellent and customer orientated
partner providing products and services of finest quality.
This philosophy serves as a framework for a long term cooperation with our partners.
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