Several years ago, at its headquarters in Wolfertschwenden, MULTIVAC built a cleanroom in which customers can carry out machine acceptances (so-called Factory Acceptance Tests, FATs) and initial sample productions, and which can also be used for testing and optimising new packaging solutions. This arouses great interest among manufacturers and packers of sterile medical products which are usually packed in cleanrooms that are Class 7 or higher.
“We are able to draw on the years of experience gained and are constantly increasing in our own company’s cleanroom,” says Heinz Wegmann, Project Manager and specialist for cleanroom applications in the MCP business unit at MULTIVAC. “Our customers can carry out initial sample productions, certified tests and FAT machine acceptances in our cleanroom under genuine production conditions. In addition to this, customers are also able to test complementary systems and components of their packaging solutions, such as printing systems, for their cleanroom compatibility.” The experienced MULTIVAC specialists perform detailed measurements and evaluation, from which the solutions can be assessed and optimised, if necessary.
The cleanroom meets the requirements of ISO Class 5. “Cleanroom Class 5 means that one cubic metre of air contains a maximum of 832 particles with a size of one micron,” explains Heinz Wegmann. When packing medical products, cleanroom Class 7 or 8, where a 100 or 1000 times higher particle count per cubic metre of air is permitted, is generally sufficient.
When carrying out the tests, MULTIVAC brings the relevant machine into the cleanroom and measures the emissions during the packaging procedure. The measurements are taken under production conditions, in other words the same materials and dies are used, which are also used later in the production environment. “The assessment of cleanroom compatibility relates not only to the machine but also to the packaging procedure. It is equally important in this regard, that emissions during packing also remain low,” adds Heinz Wegmann, explaining the background to the procedure. As soon as the products, packaging materials and machine parts start to move, friction forces arise that inevitably release particles.
During the tests, MULTIVAC and the customer check a wide range of parameters in different machine operating statuses so that the influence of the packaging materials and various process stages can be described more accurately. Based on these results, the packaging solution can be optimised if required.
MULTIVAC uses the cleanroom for the investigation of particle formation and emissions in machines and lines that have been recently developed. MULTIVAC’s portfolio includes several cleanroom-compliant models where the results of measurements in the cleanroom have flowed into the development of the machines: various thermoforming packaging machines can be designed for cleanroom conditions, and the T 260 traysealer and the TC series of chamber machines with permanently heated sealing bars are suitable for use in cleanroom conditions. The results of these tests not only serve to improve the further development and optimisation of all packaging solutions, but this comprehensive know-how also flows into the configuration of machines specially tailored to customer requirements.
In order to meet the individual requirements of customers efficiently and reliably, our team of experts also offer a wide spectrum of support services and technical assistance. This includes a qualification and validation package, which complies with the GMP, GAMP5 and ISO guidelines. If requested, MULTIVAC can also support qualification and validation procedures on site, or help with the creation of special validation or retrospective validation for packaging solutions, which have already been installed. In addition to cleanroom tests, the range of services also includes comprehensive project management and worldwide customer service, as well as training courses at the Training & Innovation Center in Wolfertschwenden or on site at the customer.