Baxter BioPharma Solutions is a contract manufacturer of pre-filled syringes, vials and cartridges for the packaging of vaccines and drugs to treat chronic conditions such as rheumatoid arthritis and multiple sclerosis.
The company invested $125m (in stages over seven years from 2003) on an expansion of its manufacturing and packaging facilities located in Bloomington, Indiana, US.
The phase IV 162,000ft² extension was completed in 2006 provided much needed additional capacity for the provision of parenteral contract manufacturing and packaging services to small and medium pharmaceutical and biotech companies. Out of the 162,000ft², the manufacturing area comprised 37,500ft², with the rest alloted to packaging and warehousing.
The expansion increased manufacturing capacity of pre-filled syringes from 100 million to 200 million per year.
The basic design was completed in March 2003 and then in June 2003 Baxter announced plans for the expansion that would result in 700 more new jobs – 400 as a direct result of the expansion and 300 coming from normal business growth – by 2006. By June 2004, one year after the expansion announcement, the company had already added approximately 300 employees to its original workforce of 560.
Performance qualification (PQ) for the extension began in January 2004, and was completed in April 2005. The overall detail design and construction schedule was 17 months. After completion of operational qualification (OQ), performance qualifications and media fills were performed in only 4 months by BPS, resulting in the facility being passed as satisfactory by the FDA in June 2005.
The total project schedule from design to licensing was 22 months. The new capacity was ready for new client product launches in early 2006. The expansion programme required an investment of $116m.
Construction and contractors
The facility was designed by Raymond Professional Group and the general contractor for construction was the Turner Construction Group. Pharmadule of Sweden was responsible for the design and building of the process facility, which was built on a modular basis. Pharmadule fabricated and preassembled the modules at their facility in Sweden before shipping them across to Baxter for final assembly.
A modular approach allowed for the quick installation of the manufacturing unit. The extension required the demolition and clearance of some existing buildings around the site, and then construction of the new buildings of the extension. Baxter broke ground for the new buildings in April 2003 and topping out occurred in April 2004. Modules fabrication began in October 2003 and they arrived on site by August 2004. Their installation was complete by September 2004 and reassembly of the facility was completed by October 2004.
For the packaging facility the developer was the Koll Development Company of Dallas, Texas. The architect was Odle McGuire & Shook of Indianapolis and the construction was carried out by Weddle Bros Construction Company of Bloomington.
The process equipment was provided by the following suppliers: water pre-treatment system provided by US Filter, two clean steam generators were supplied by Kemiterm Getinge. The reverse osmosis (RO) tank was supplied by Zetterström. A still was supplied by Kemiterm Getinge. The water for injection (WFI) loop and systems was supplied and installed by Pharmadule. Process automation was the remit of Pharmadule/Orbitec. A WFI-tank of 25m³ was provided by Zetterström.
A clean steam system was supplied by Pharmadule. Getinge supplied three autoclaves and a terminal steriliser for the facility. Two clean-in-place (CIP) systems were supplied by Pharmadule. Carrier and Holland Heating supplied 13 air handling units (AHUs) for the heating ventilation and air conditioning system (HVAC) system.
Voltec supplied the control system and building management system for the HVAC. Particle monitoring systems were supplied by Climet. Meter Toledo supplied two scales. Pharmadule supplied and installed seven heating cooling skids.
The blister packaging and the new filling lines were supplied and installed by Optima Packaging Group of Germany in conjunction with INOVA.
A machine vision system to track syringe accountability was designed and developed by Frakes Engineering of Indianapolis.
The automated inspection system to detect syringe defects was designed by Eisai Equipment of Hackensack, New Jersey.