The Bosch subsidiary Pharmatec GmbH, based in Dresden, Germany, has developed a complete range of fully standardized systems for formula preparation, storage and transfer to filling lines. The range covers the production of different liquid forms: solutions, suspensions and emulsions, with production capacities between 8 and 1,000 liters. It is an ideal solution for small volume parenteral (SVP) manufacturing.
Standardization is a trend in any mature market. It is the answer to the search for greater competitiveness. In pharmaceutical technology, the market has been increasing the level of standardization in high added value equipment for years. Examples of this trend are autoclaves, freeze dryers, filling lines, distillers etc. Even in water generation, which has lots of variations due to the physico-chemical and biological nature of the water sources, suppliers also offer a high degree of standardization in equipment and systems.
Standardization implies adapting the features of the equipment and systems to ensure compliance with norms and guidelines. Pharmaceutical manufacturers have the choice between multiple options for each application or case. And yet, reliability of the equipment is strengthened while costs are reduced and delivery times shortened thanks to the repetition of proven designs.
However, when it comes to process equipment for preparing, storing and transferring liquid pharmaceuticals, no studies of needs and applications exist to date at the level of both engineering and pharmaceutical technology. Hence Bosch’s approach of standardizing these solutions can be seen as a true innovation.
The standard modular systems for manufacturing liquid pharmaceuticals from Bosch have been designed to offer maximum flexibility. There are up to six different layouts (overall dimensions), each one based on a maximum production capacity of 50, 100, 150, 300, 500 and 1,000 liters. Each of these six systems can be offered with two types of reactors: cylindrical (Baseline) or conical (Proline), whereby the conical version has a greater volume range. An important feature of the standard solution is its total modularity. The same design and configuration can be applied to each production capacity. The only thing that changes is the size of the system, which is the case with any other category of equipment as well.
Just like other categories, the SVP systems are designed to be installed between two different areas: the production area with the preparation and storage tanks, components, field sensors and conditioning elements (LAF, isolators etc.), and the technical room, where the necessary services for the process are installed: CIP/SIP, nitrogen, heating or cooling systems etc. All this is pre-installed and connected in a compact way and separated by a cleanroom panel that allows an easy set-up on site and a faster commissioning phase. This makes it possible to perform more comprehensive FAT tests to ensure that the installation delivers the required performance, while decreasing risks or failures.
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With this standardization approach for modular and compact process systems for the preparation of liquid pharmaceuticals, Bosch has added a new equipment category to the pharmaceutical technology market. During project planning, the process systems make it possible to predict the space requirements and their utilities with a very high level of accuracy. They have a wide range of options to adapt to the different liquid pharmaceutical forms and the existing production capabilities. The standardization also facilitates FAT tests, reduces costs and shortens delivery times.