Facilities
Manufacturing Facility
The new ORION manufacturing plant is based at Balcatta, Western Australia.
Our new, custom-built expanded facility, in Balcatta, has been completed. Equipped with modern and comprehensive manufacturing equipment and utilities , the facility was TGA approved in January 2004 and fully commissioned in August 2004.
Operating to the strictest international codes of Good Manufacturing Practice and with expanded capacity, products can be manufactured, packaged and supplied in a variety of forms and pack sizes, or supplied in bulk packs as required.
The Company's specialised equipment, expertise and experience are available to clients seeking the manufacture and packaging of therapeutic goods, veterinary products and cosmetic preparations.
Our facilities include:
- Segregation of operations by means of separate mixing and filling rooms;
- Controlled air flow management systems;
- Dedicated production zones for different products;
- Raw Material dispensary;
- Purified Water system;
- Quality control processes and testing facilities;
- Class C clean room for filling terminally sterilized products.
Compounding
The Compounding facilities complies strictly with the Therapeutic Goods Administration regulations within the Code of Good Manufacturing Practice.
Conditioned air for general areas of the manufacturing facility is provided by way of pre-filters followed by terminal filters of 95% efficiency. Return air from defined areas within the facility is used to make up the air supply after filtration.
Exhaust filter in the dispensary and other specialised manufacturing areas are via HEPA filters. The controlled airflow management system protects the integrity of the product in the manufacturing process. The walls, floor and ceiling are of a smooth impervious easily cleanable surface. The construction of the sandwich panel provides an improved level of fire resistance. Recessed light fittings are of clean room construction.
Filling and Packing Operations
All packaging operations are conducted within a clean working environment. Filtered, conditioned air supply to the packing area is monitored to ensure contamination is minimised. Conditioned air for the class C cleanroom is supplied via terminally mounted HEPA filters. Point of use exhaust filters and medical air supplies are in place.
The facilities have been constructed to comply with Therapeutic Goods Administration Regulations.
The liquid filling lines incorporate automatic or semi-automatic fillers, cappers and self-adhesive labelling machines. The tube filling lines are equipped with either an ultrasonic or a heat sealing head dependent on the tube material. The finished pack can be cartoned and shrink-wrapped. All packaging operations comply with the Code of Good Manufacturing Practice.
Quality Assurance Testing
The Quality Assurance laboratory is equipped with precise analytical equipment such as HPLC (High performance liquid chromatography), GC (Gas Chromatography) and many others for the testing of raw materials and finished products. A team of chemists perform quantitative and qualitative analysis in accordance with good laboratory practice under the code of GMP.
Quarantine Area
All incoming goods including raw materials and packaging are placed in Quarantine awaiting sampling for quality control testing. Sampling of materials is carried out in air-conditioned sampling rooms and forwarded onto QA for checking, testing and release for use. The quarantine area forms part of the warehouse facility.
Warehouse and Distribution Facilities
The warehouse is licensed to store quarantine and approved materials for production use and finished products for distribution. It is equipped with air-conditioning to maintain a controlled temperature environment. The entire area is designed for optimum insulation and dust protection. Material flow, through an airlock system is designed to minimize contamination.
