Facilities & Operations
FGB Natural Products (FGB) is an independent Australian owned and operated pharmaceutical company specialising in natural products. Manufacturing and marketing a range of over the counter (O.T.C.) pharmaceuticals, nutritional supplements, household products, personal care products and medical devices in pharmacies and supermarkets throughout Australia and in a growing number of export markets. FGB is the largest fully integrated producer and manufacturer of eucalyptus oil and eucalyptus oil based products, being 'first in eucalyptus' since 1852. FGB’s Head Office, Warehouse and Manufacturing complex is strategically located in Oakleigh South on a prime site in the heart of the distribution centre of Melbourne, Victoria. The warehouse is state of the art with the facilities to offer complete business solutions. The warehouse and Dangerous Goods (DG) facilities are Therapeutic Goods Administration (TGA) compliant. From flammable goods storage to warehouse and distribution facilities FGB will be able to work with you to find a complete solution to suit your business.
Distribution & Warehouse FacilitiesThe 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 export markets.
The DG Warehouse has the capacity to hold 976 pallets and the non DG warehouse will hold 1,260 pallets when fully racked. A state of the art Manufacturing Suite is incorporated in the DG building. This suite is fully TGA and DG compliant and houses a 10,000 litre blending vessel. The building is environmentally friendly, making use of natural light and has a 70,000 litre underground tank for harvesting rainwater.
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.
Contract ManufactureFGB’s specialised equipment and knowledge are available to clients seeking the manufacture and packaging of flammable liquids, nutritional or O.T.C pharmaceutical liquid products, or the assembly of Class 1 medical devices in an approved pharmaceutical facility. FGB can also offer a variety of secondary packing services in an approved, Good Manufacturing Practice (GMP) controlled premises.
Why choose FGB:
Blending Operations – Flammable Goods
The blending facilities are designed and constructed to comply with TGA regulations in the GMP code and DG regulations applicable to the manufacture of flammable liquids in a Class 1 Zone One 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 are constructed to comply with both the TGA regulations and DG 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 and particle 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 SuiteThe premises also house a state of the art liquid mixing and filling suite designed for nutritional and OTC pharmaceuticals. The self contained suite is HEPA filtered and complies with 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 labeller and shrink tunnel capable of handling a variety of sizes from 25mL to 500mL.
Laboratory
The premises house a well equipped laboratory containing modern instrumentation. Tests performed include gas chromatography (GC) and high performance liquid chromatography (HPLC). FGB has highly competent technical staff in areas including product development, analytical method development, stability, validation and regulatory affairs.
Regulatory LicencesAll therapeutic products and O.T.C. pharmaceuticals are manufactured to comply with the TGA regulations. All therapeutic goods marketed by FGB are either registered or listed on the Australian Register of Therapeutic Goods administered by the TGA (FGB License Number 36782). The premises are licensed by the TGA and comply with the GMP Code 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.
For further information please contact:Ian Marshall
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