Albiox provides the development and processing of products, such as depyrogenation, packaging and sterilization services such as gamma-, ethylenoxide-, steam sterilizations and process validation to meet the demands of the drug and diagnosis industry.
Sterilization
We offer full product support. Development/Feasibility, engineering, validation and commercial terminal sterilization of liquids in sealed vessels (aseptically filled drug products in vials, IV bags, syringes, blow-fill-seal technologies and others), plastic bottles and tubing, glass vials, stoppers and seals, cell culture bags, manufacturing equipment (scissors, hemostats, forceps, etc.).
Depyrogenation
In pharmaceutical industry it is important to remove bacterial endotoxins from the solution or surface of the instruments used in the manufacturing of medicines. Depyrogenation provides the removal of all gram negative endotoxins from the surfaces at high temperatures.
Albiox provides the most commonly used dry heat depyrogenation. The process of destroying endotoxin through exposure of 250°C.
Water for injection (WFI) rinsing
The European Medicines Agency have provided guidelines on the cleaning water quality for items that come in contact with products for pharmaceutical use. Manufacturer should perform a final rinse of equipment, containers and closures with water that is the same quality of that used in the manufacture of medical product.
WFI quality water is typically generated using a combination of filtration, reverse osmosis, and distillation and is stored prior to use heated at around 70-80ᵒC. The water has a low conductivity, low total organic carbon levels, virtually no viable organism and low endotoxin allowances.