Bacterial Fermentation Facility Capacity Upgrade
The project involved increasing the bacterial fermentation suite production capacity from the current 150 Litre fermentation capacity to 2000 Litres fermentation capacity. The production capacity increase was conducted within a new building extension which interfaces directly with the existing production facility. The expansion required new standalone utilities including chilled water, heating hot water, steam and compressed air. Existing services which required upgrading include distribution to the new areas, modification of the existing Purified Water reticulation service and modification of the existing Clean Steam system. Additional services which will be required to support the new facility include a chemical bund for the chemicals required for CIP system, liquid waste decontamination and trade waste cooling and neutralisation relocation of the existing bulk liquid nitrogen tank to enable the vessel to be safely filled.
MSD Animal Health – February – scheduled completion November, 2019
Purified Water Piping Replacement
This project involved the replacement of the existing piping used for reticulation of USP Purified Water at the MSD production facility with 316L high purity stainless steel piping.
USP Purified Water is reticulated from the 10,000 litre Purified Water storage vessel in the Plant Services Plantroom within the Production building to users within the Production building, Quality Control Laboratory and Pilot Laboratory.
The scope of the project was to remove and replace the existing ABS plastic piping used to reticulate USP Purified Water on site with orbitally welded and fully traceable 316L stainless steel piping installation that complies with the GMP requirements of a USP Purified Water system.
MSD Animal Health – January – April, 2019
Parkville HP Compressed Air Upgrade
This project involved expanding the capacity of the site compressed air system.
Installation of two new compressors, two wet receivers, two new air preparation trains external to the compressor house and refrigerated drier.
This incorporated back end work (in main headers etc) to accommodate the installation, all new pipes being sched 10 6-8”.
Modification to existing receiver’s pipework to maintain original receivers as back up to new system.
Seqirus – January – May, 2019
Building 5 – Segregation
Installation of new WFI loop system, Glycol jacketed Product lines, Pharma Air & Nitrogen into new manufacturing suits. Installation of required heat exchangers, including associated services- chilled water, steam and condensate. Installation of new vial washer and drying tunnel including connection of required services.
Pfizer – July 2018 – January 2019
Building 1 – Liposome
Installation of new WFI loop system, clean Nitrogen, Pharma Air & Process Heating/Cooling lines into new manufacturing suits.
Installation of new waste treatment plant.
Plant room works including installation of heat exchangers and required services – Chilled Water, Steam & Condensate. Installation of new WFI Still. RO water supply to still.
Pfizer – June – December, 2018
FM 3 & 4 Upgrade Phase 2 Project
Offsite manufacture then site installation of 2 new Balloon Air Skids and supporting services for Ventolin production.
Services including Product (Ventolin), Compressed Air and Clean Steam.
GlaxoSmithKline – March – September, 2018
Oral Solution Dosing Facility Upgrade
Installation of all process services within the new Oral Dosing Solution Facility process area of Mayne Pharma.
Process services were installed to Fluid Bed Dryer (GLATT) and Solution Tanks within Spray Coating production area, High Shear Granulator (SMA) within Granulation production area, Sieve within Sieving production area, Tablet Press (SMA) within Tablet Compression production area and Tablet Coater (Sejong) within Tablet Coating production area.
Services included: Installation of new Pure Water storage (10,000L tank) and reticulation system (14 user points throughout the facility), installation of Wash-In-Place skids (GLATT, SMA & Sejong), Ethanol, Clean Steam, Pure Nitrogen (99.999%), Medium Pressure Steam & Condensate, Domestic Hot & Cold Water, Instrument Air and Pharma Air.
Mayne Pharma – August, 2017 – March, 2018
IgLab Module IV – Privigen & Hizentra, 0.2μm Filtration Sterilisation
Installation of all process services in the 0.2μm Filtration & Bulk Storage Vessels production area of the new IgLAB Module IV, located within the Turner Facility at CSL Behring.
Process services were installed for Tank H3 & Tank H4 within the Sterile Filtration production area and technical corridor.
Services included: Product, Clean-In-Place Supply & Return, Filtered Compressed Air, Pure Steam and Water For Injection.
CSL Behring – March – April, 2017
IgLab Module IV – Privigen & Hizentra, Subfractionation
Installation of all process services in the Bulk Subfractionation production area of the new IgLAB Module IV, located within the Turner Facility at CSL Behring.
Services were installed to Tank A2, Filter Press 3, Tank B2 & Ultra Filter 4 within the production area and technical corridor.
Services included: Product, Sodium Acetate, Clean-In-Place Supply & Return, Pure Steam, Water For Injection, Hydrochloric Acid, Filtered Compressed Air and Octanoic Acid.
CSL Behring – February – July, 2017
AlbuRx Special Waters Building – MF Permeate and PWG
Decommission of existing Microfiltration (MF) Permeate Tank (10,000L) and installation of new MF Permeate Tank (30,000L) in the Special Waters Building of CSL Behring.
Installation of new Microfiltration unit.
Installation of new Pure Water generator.
Services included: Mircofiltration, Purified Water, Reverse Osmosis, Compressed Air and Domestic Cold Water.
CSL Behring – December, 2016 – January, 2017