The Sypharma manufacturing plant is based at Dandenong, Victoria. Equipped with modern and comprehensive manufacturing equipment and utilities, the facility is TGA and APVMA approved Operating to the strictest international codes of Good Manufacturing Practice, 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 consumer items.
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
- Class A & B clean rooms for aseptic filling
- Biopharmaceutical Formulation Suite
- Powder manufacturing and packaging
- Medical Device Manufacture
Our Compounding facilities strictly comply with the Therapeutic Goods Administration (TGA) and Australian Pesticide and Veterinary Medicines Authority (APVMA) 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 specialized 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 explosion proof construction.
Filling and Packing Operations
Our packaging operations are administered within a sterile 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. Class A and B clean rooms are monitored to an even greater extent.
The facilities have been constructed to comply with both Therapeutic Goods Administration Regulations and Dangerous Goods Storage and Handling Regulations.
The liquid filling lines incorporate automatic or semi-automatic fillers, cappers and self-adhesive labelling machines. The finished pack can be cartonised 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 NIR (Near Infra Red), HPLC (High performance liquid chromatography) and other equipment for the testing of raw materials and finished products. A team of several chemists perform quantitative and qualitative analysis in accordance with good laboratory practice under the code of GMP.
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 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 reverse cycle 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.