Premises
FGB's Head Office, Warehouse and Manufacturing complex is of a very high standard and is strategically located on a prime site in the heart of the distribution centre of Melbourne, Victoria. FGB harvests and extracts eucalyptus oil from approximately 5,000 hectares of Eucalyptus polybractea, better known as “Blue Mallee”, near Inglewood and Wedderburn in the north central region of country Victoria.
Blending Operations - Flammable Goods
FGB's blending facilities have been designed and constructed to comply with the Therapeutic Goods Administration regulations embodied in the Code of Good Manufacturing Practice and Dangerous Goods Regulations applicable to the manufacture of flammable liquids.
The blending operation meets the exacting standards for therapeutic goods manufacture within a Class 1 Zone 1 flameproof environment.
The walls, floors and ceiling are of an impervious construction. Hepa filtered air is supplied and extracted via flameproof ventilators to both protect the integrity of the product and safeguard against vapour build-up. Recessed light fittings are of explosion proof construction. Pumps, stirrers and other mechanical equipment are either fitted with flame-proof electrics or are pneumatically operated.
Packing Operations - Flammable Goods
FGB's liquid filling and packing facilities have been constructed to comply with both the Therapeutic Goods Administration regulations and Dangerous Goods Storage and Handling regulations.
The packing room is primarily equipped to fill flammable therapeutic liquids into bottles.
The filling lines incorporate a high-speed filler, capper and self-adhesive labeller and have the facility to shrink pack bottles. The packing area is also equipped to assemble therapeutic devices under Good Manufacturing Practice conditions.
Hepa filtered, conditioned air supplied to the packing area is periodically microbiologically monitored to ensure a clean working environment is maintained. An air extraction system incorporated into the walls of the cubicle that surrounds the liquid filling station provides a safe working environment for flammable liquids.
Clean Room (Class D) Mixing and Filling Suite
The premises also houses a new state of the art liquid mixing and filling suite designed for nutritional and OTC pharmaceuticals. The self contained suite is HEPA filtered and easily surpasses Class D requirements.
The suite consists of an air-locked entry area, separate dispensary and mixing and packing rooms. Batch sizes range from 300 litres to 2500 litres. The automated liquid filling and packing line incorporate 4 head piston filler, automatic capper, high speed labeler and shrink tunnel capable of handling a variety of sizes from 25mL to 500mL.
Flammable Goods Storage
FGB has a purpose built flammable goods storage facility built to comply with the Storage of Dangerous Goods Regulations. This high span storage building is appropriately ventilated and is positioned away from other buildings and boundaries. The insulated building provides segregated storage for up to 80 pallet lots of raw materials and finished goods in a secure therapeutic goods environment.
Warehouse and Distribution Facilities
The entire internal warehouse area is finished to a high standard. The floor is covered with polished vinyl tiles.
A suspended ceiling has been fitted throughout the entire area for optimum insulation and dust protection. The warehouse is equipped with reverse cycle air-conditioning for use at times of extreme weather conditions to maintain a controlled temperature environment.
The warehouse is licensed to store and wholesale scheduled pharmaceuticals. Goods dispatched from the warehouse are regularly consigned to pharmaceutical wholesalers Australia wide and to the major supermarket chains. Deliveries are also made to major hospitals and a variety of other businesses throughout Australia and in our export markets.
Regulatory Licences
All therapeutic products, including over the counter (O.T.C.) pharmaceuticals, are manufactured to comply with the Therapeutic Goods Administration regulations. All therapeutic goods marketed by FGB are either registered or listed on the Australian Register of Therapeutic Goods administered by the Therapeutic Goods Administration (FGB License Number 36782). The premises are licensed by the Therapeutic Goods Administration and comply with the Code of Good Manufacturing Practice for Therapeutic Goods.
FGB is registered for the storage and handling of Class 3 flammable liquids as required by the Dangerous Goods Act 1985 and Dangerous Goods (Storage and Handling) Regulations 2000. FGB licensed by the Australian Pesticides and Veterinary Medicines Authority (previously the NRA), License Number 2053.
Laboratory
The premises house a well equipped laboratory containing modern instrumentation. Tests performed can include gas chromatography (GC) and high performance liquid chromatography (HPLC).
Contract Manufacture
FGB's specialised equipment and knowledge are available to clients seeking the manufacture and packaging of flammable liquids, nutritional or OTC pharmaceutical liquid products, or the assembly of Class 1 medical devices in an approved pharmaceutical facility. The Company can also offer a variety of secondary packing services in an approved, GMP controlled premises.
For further information please contact:
Michael McKelvie
Chief Executive Officer
Gregg Allison
Manufacturing Manager
