CSIRO – National Vaccine and Therapeutics Lab

Client

CSIRO

Location

Melbourne, Australia

Core Capabilities

Project management
Concept design and detailed design
Specialist multidiscipline engineering including process, mechanical, electrical, control, and automation engineering
3D modelling
Commissioning
Good Manufacturing Practice (GMP) validation and compliance services
V-model systems engineering lifecycle analysis
Tender packages and evaluation
Construction phase support

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Project Summary

Synertec was engaged by CSIRO to design, support procurement / construction, commission and qualify a new multiproduct facility to produce a variety of biological therapeutic goods through cell culture, utilising monoclonal antibodies. The facility utilises single use bioreactors, upstream and downstream process equipment primarily from Cytiva. The final facility design included delivery of the following:

Grade B and Grade C cleanrooms with associated
HVAC (heating, ventilation, and air conditioning) systems
Personnel change locks, material storage areas, and material transfer locks with associated pressure cascades to comply with requirements for good manufacturing practice (GMP) sterile medicinal product manufacturing as well as OGTR containment.
Water for injection and pure steam generation and distribution systems
Product contact compressed air and bottled gases supply and reticulation
Clean and waste autoclaves
Liquid waste transfer facility
Sterile filling isolator
Environmental Monitoring System, and
Life Safety System.

The Challenge

CSIRO required a partner with strong expertise in GMP coupled with experience in designing and implementing facility expansions on brownfield sites, without interruption to normal operations.

The project also required engagement with the Therapeutic Goods Administration (TGA) of Australia for in principle approval of this first in Australia facility for single use technology of multi-product biologicals for both active pharmaceutical ingredient and final product manufacture including sterile filling.

Synertec’s team of experienced GMP engineers worked closely with CSIRO to ensure compliance with all relevant regulatory requirements in the design, construction, and qualification phases of the project.

Synertec's Solution

Engaged for project management, design, construction support and to manage all commissioning, validation and compliance requirements for the new facility, Synertec’s accountabilities spanned the entire lifecycle of the project and included providing governance and oversight across the following activities:

Concept design, detailed design and 3D modelling
Requirement specification, work package development, tender evaluation and contractor management
Project schedule development and maintenance
Commissioning, qualification and compliance services
Training, Building User Guides, operation and maintenance manuals and maintenance schedules
Computerised maintenance management system
(CMMS) implementation
Development of standard operating procedures
(SOPs), and
Computerised System Validation (CSV) including specification and protocol development and protocol execution of GMP compliant computer network.