PM Group

Janssen, a fully owned subsidiary of Johnson & Johnson, constructed €100m active pharmaceutical ingredients manufacturing facility at its site in Cork, Ireland.

The company focuses on some very specialised products. Many of these products are extremely active so their manufacture must be specially designed due to conflicting requirements of high containment versus high cGMP.  A further challenge in this project was that one of the production suites needed to be able to manufacture aseptically for downstream purification reasons. One of its products would be delivered intravenously for efficacy reasons.

This new 7,500 m² development consisted of three production modules for different categories of products.  Each stand-alone module has dedicated utilities serviced from a Central Utilities Building.  Additionally the sterile suite has clean utilities to support production. An integrated laboratory, office and warehouse block is also present to support the production suites.

Project Features:

• Bulk Sterile API 
• High Containment (pbOEL3b)
• Centrifuge Drying
• Bulk Sterile Pack-off 
• Fully integrated CIP / SIP
• Materials Handling
• Full Clean Room Design
• Class C & D process areas 
• Micro /Sterile Laboratories
• 'Stand alone' processing

PM Responsibilities Include:

• Detailed Design
• Procurement / Expediting
• Construction Support
• Commissioning Support
• C/Q Document Preparation
• FAT Preparation /Execution
• Qualification Execution
• CE Conformity