Project Summary

Synertec was engaged by Aspen Pharma to relocate (interstate), commission and validate (IQ, OQ, Packing Validation) a sterile vial packing line including a Blister Line, Autoclave and Hand Packing line.

The Challenge

Aspen Pharma required a partner with strong mechanical and electrical capability for equipment relocation, combined with the knowledge and experience of the GMP environment and ability to prepare and execute qualification documents covering IQ, OQ and Packing Validation.

Challenges included:

• Removal of large, heavy equipment weighing up to 5T with a length of 7m from first floor of sterile manufacturing facility
• Installation, commissioning and qualification of relocated equipment

Synertec’s Solution

Synertec prepared a multidisciplined team experienced in the requirements of GMP to disassemble and remove all equipment from the facility located in Sydney, followed by transport interstate and installation at Aspen’s pharmaceutical manufacturing facility in Dandenong South.

Synertec managed the process of installation and commissioning of the equipment including trouble shooting operational issues such as damaged tooling, equipment modifications, and control system upgrades. Synertec also wrote and executed Installation and Operational Qualifications of the relocated blister packing lines.