Cleanroom

cGMP clinical manufacturing and training: Fast track your R&D

TRI provides the infrastructure and regulatory compliance necessary for small-scale manufacture of medicines for human use. Our cGMP cleanroom facility is ideal for producing clean to sterile medical devices, biotechnology, pharmaceutical and cell-based products for Phase I clinical trials.

Key Facts:

The only facility of its kind in Australia servicing the medtech and pharmaceutical sectors.
Onshore accelerated translation of new medicines and devices for early-stage clinical trials.
Open to TRI and non-TRI researchers and organisations.
Good Manufacturing Practice (cGMP) compliance and training
Operates as a BYO facility – infrastructure managed by experienced cGMP staff

Cleanroom Services Manager

Arman Ergenekon

cleanroom@tri.edu.au

cGMP clinical manufacturing and training: Fast track your R&D

TRI provides the infrastructure and regulatory compliance necessary for small-scale manufacture of medicines for human use. Our cGMP cleanroom facility is ideal for producing clean to sterile medical devices, biotechnology, pharmaceutical and cell-based products for Phase I clinical trials.

Key Facts:

The only facility of its kind in Australia servicing the medtech and pharmaceutical sectors.
Onshore accelerated translation of new medicines and devices for early-stage clinical trials.
Open to TRI and non-TRI researchers and organisations.
Good Manufacturing Practice (cGMP) compliance and training
Operates as a BYO facility – infrastructure managed by experienced cGMP staff

Cleanroom Services Manager

Arman Ergenekon

cleanroom@tri.edu.au

Capabilities

5 segregated cleanrooms (ISO14644-1/AS 1807.6/GMP compliant Class 5-7/Grade B/C) capable of servicing the manufacture of low bio-burden to sterile products.

AP-IS 2 Pharmaceutical Isolator – Sterile processing with vapourised hydrogen peroxide decontamination, continuous particle monitoring and active air sampling
Environmental Monitoring System (EMS) – Monitored, secured, and alarmed
GMP Autoclave – Steam sterilisation of compatible materials, utensils, and equipment
Pharmaceutical Quality System (PQS) – Externally audited, continuously improved, and TGA compliant
Secure storage and monitoring – 24/7 critical systems monitoring (BMS), on-site security as well as swipe card restricted access to all rooms

Manufacturing

TRI’s cleanroom provides state-of the art facilities suitable for Phase I clinical trials and small-scale batch manufacture.

Services We Offer

Secure access, unidirectional flow paths
Manufacturing suites with dedicated HVAC that meet Grade B classification
Environmental Monitoring System (EMS) and portable EM equipment
Aseptic Processing Isolator System
GMP training
General maintenance and customer support

Services Not Available

Stock management / procurement
Cleaning services of the classified areas
Environmental monitoring services (beyond the equipment provision)
Validation services (beyond initial qualification of TRI owned equipment)
Staff and fee for service
Manufacturing / process-specific equipment

Training

All mandatory TRI building inductions are required before access may be granted to the TRI premises. Additional training including induction and gowning training is required to access to controlled GMP spaces and cleanrooms.

Need more help?

For more information on custom requirements, pricing, services and facility capacity contact the Cleanroom Services Manager.