The project which has spanned several years is not yet complete. But nonetheless, it is clear that new process knowledge has been won which will find use in future projects with Octapharma. Because it is to an extent a “learning” project, Mr. Dominique Sierakowski gives an interim report in an interview, including background information and decision making parameters from his perspective as Head of Pharmaceutical Production.
A European company that exclusively supplies veterinary medicine products operates a line from Optima Pharma equipped with a washer, sterilization tunnel, and filling and closing machine. The challenges of this project involved processing a very large format range all under aseptic conditions. Various system properties ensure cost-effectiveness and the high product quality that is appreciated by veterinarians around the world.
Specific requirements – special solutions. A line for flammable(alcohol based), sterile, liquid and viscose fluids with a broad format range up to 1000 ml is a rarity in pharmaceutical manufacturing. The first of its kind is going into service at Schülke & Mayr GmbH.
The pharmaceutical industry is currently in a state of flux. The introduction of classic blockbusters is diminishing. At the same time, biotechnology is just beginning to discover its potential. Gene therapy and personalized medicines are further forms of therapy which are showing signs of a promising future.
The first processing step in the Biomabs vial line is cleaning. An infeed turntable transfers the vials to the INOVA WMR 1800 washer, which grasps the vials and flips them 180 in groups of four enabling them to be washed both inside from the bottom and outside. As the needles move with the rotary unit, they are inserted into the vials from the bottom at which time they inject recirculated water to remove any particulate matter that may be in the vials. The final steps in the washing process are air rinse, final WFI (Water for Injection) rinse, and blow drying.
To meet the applications profile, the infeed to the KUGLER LINOLINE had to contain both a bottle sorter and an infeed turntable. When plastic bottles are being processed on the line, they are loaded in bulk into a disk sorter. An optical inspection station checks to ensure that the bottles are oriented correctly for transfer to the linear transport system. Pressurized air is used to return bottles that are not in the proper position.
Evidently reasons for innovative pharmaceutical manufacturing system must be most compelling. Otherwise, drug manufacturers would not be prepared to leave the path of proven solutions and to accept the enormous initial certifications, efforts and costs. The SteriCon procedure is a very recent approach, but already much in demand, with first projects taking up operation in 2010.
A wide range of diagnostic tests are manufactured on the system: the eight cavities per multi-cartridge are each dosed with minimal quantities of different types of liquid. These are alcohol-based products (and therefore at risk of explosion), buffer solutions and magnetic beads. The latter contain extremely small metal spheres whose surfaces are coated with antigens. Some of the suspensions are volatile enough to generate explosive environs