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Pioneering facility for safe production of sterile active pharmaceutical ingredients


To meet new authority requirements, Baxter Oncology GmbH needed to provide safer operating conditions for its high-potent active pharmaceutical ingredients (APIs) production facility.

NNE Pharmaplan was commissioned to design and implement a new facility that would be one of the pioneer projects within the high containment sector.

Instead of using a conventional clean room facility for producing sterile, high-potent products, Baxter Oncology (formerly Asta Medica) had to change to a facility offering optimum protection for both products and employees.

Faced with the decision of upgrading its current facility or building a new one, the company chose NNE Pharmaplan to design and build a new greenfield facility. This would handle the entire process from sterile crystallisation up to the final fill and finish.

Combining employee safety and productivity demands
Making use of closed systems or isolator systems, NNE Pharmaplan’s innovative design provided the necessary level of protection to products and people throughout the production process.

NNE Pharmaplan’s process experts provided specialist support and advanced process know-how in the area of isolator barrier technology. Working together with Baxter Oncology and a third-party supplier, they developed a prototype for a filling machine in isolator technology for powder filling in vials.

 

 

Got questions?

Gerd Gregor
Sales Manager, Germany


Tel+49 6172 8502-100

facts


Client
Baxter Oncology GmbH, Germany (formerly Asta Medica GmbH)
Client's success factors
To get optimum support for handling high-potent APIs and further processing
Project duration
Nov. 1997 – Nov. 2000
Service provided
Conceptual design
Basic design
Detail design
Procurement support
Construction and installation management
Commissioning management
Qualification (Validation Master Plan, DQ)


NNE Pharmaplan 2008
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