Mylan Sterile Fill Finish Facility

Services

Mylan

RPS has been engaged with Mylan Inc. in a number of programmes to upgrade the Bioniche Pharma facility in Co. Galway and has recently committed to another large-scale venture in Co. Dublin.

Bioniche Pharma is a global manufacturer of injectable pharmaceutical products serving a variety of niche markets, with expertise in aseptic fill finish processing.

Bioniche Pharma was acquired in September 2010 by Mylan Inc, a Fortune 500 company that ranks as one of the world's leading generic and specialty pharmaceuticals companies, providing products to customers in more than 150 countries and territories. The upgrade works at Bioniche Pharma in Inverin required pharmaceutical manufacture and vial and syringe packaging lines.RPS has been engaged in a number of programmes of capital expenditure over a number of years to develop the facility.

RPS responsibilities included:

Site Masterplanning

Project Management

Mechanical, Electrical and Process Design

Civil, Structural & Architectural

Environmental & Wastewater Treatment

Validation

 

Detailed design included:

Grade A, B,C and D cleanroom design

Mechanical and Electrical design for GMP areas

HVAC design for GMP areas

Purified Water pre-treatment and purification installation

WFI and Pure Steam system installation

Equipment specifications for all process equipment including vial washer, dehydrogenation tunnel, vial filler, syringe filler, autoclaves, compounding vessels etc.

Equipment specification and design of a CIP/SIP system for compounding vessels and transfer lines

Ongoing design review and Fat attendance for all process equipment

Generation and assistance in execution of validation protocols for mechanical, electrical and process utilities

 

To date, RPS has completed a full upgrade of a manufacturing area in Bioniche Pharma and a substantial manufacturing expansion plan and full design to construct a new Vial and Syringe Fill Finish Facility.