For the sterilisation of large-volume parenteral solutions
Telstar has supplied a set of autoclaves for the sterilisation of large-volume parenteral solutions and isotonic liquid products to the Latin American pharmaceutical firm Laboratorios Pisa. The autoclaves have been installed at the Mexican group’s plant in Tlajomulco, Guadalajara, Mexico. This supply contract for multiple pieces of equipment, which was delivered in December 2013, is to be extended by the addition of further autoclaves during 2014.
The super-heated water autoclaves developed by Telstar for Laboratorios Pisa include control systems which can compensate for the pressure differences occurring between the inside of the container and the autoclave chamber during the heating and cooling phases. This ensures that the processes occur at controlled temperature and that the physical integrity of the container is retained at the end of the cycle.
Telstar is also supplying Laboratorios Pisa with several seven-effect water stills, each with a capacity for up to 12,000 litres/hour of distilled water (WFI); some of which are in full operation and a further two now in the process of manufacture. The stills operate without requiring any cooling water. The seven columns provide more enhanced utilisation of the heating energy and as a result in the last condensation phase no cooling water intake is required. According to Telstar, this represents a significant financial saving considering such large production volumes.
The autoclaves and water stills developed for the Guadalajara plant are complemented by steam generators, each with a capacity for 1,000 kg/hour of pure steam.
The supply contract is to be extended by the addition of further autoclaves during 2014
During the course of this year, Telstar will also supply steam sterilisable freeze dryer capacity for the production of injectable products at the plant in Tlajomulco. With a freeze-drying surface area of 19.8m2, each piece of equipment has the capacity to freeze-dry a total of 33,000 vials every 40-hour cycle over 15 cycles a month.
Furthermore, two steam autoclaves for terminal sterilisation of blisters and culture media will be supplied to the plant located in the industrial area of Guadalajara, which Laboratorios Pisa uses for developing process improvements.
Laboratorios Pisa is a leading pharmaceutical and medical devices manufacturer in Latin America. It was founded in 1945, and supplies medicines and medical equipment to the public and private health and hospitals market, particularly solutions-for-injection, formulas for artificial nutrition, oral rehydration, medicines for cancer, anaesthesiology and antibiotics.