Machine acceptance tests and initial sample inspections in the cleanroom

MULTIVAC Cleanroom

Cleanroom

In the cleanroom of MULTIVAC, customers can carry out machine approvals (so-called Factory Acceptance Tests, FATs) and initial sampling or test and optimize new packaging solutions. This offer is of great interest to manufacturers and packers of sterile medical devices, which are typically packaged in cleanrooms of class 7 or higher.

The highest standards are required for the purity of medical sterile goods – for example, implants or surgical sets. Therefore, these must also be packaged under cleanroom conditions to guarantee the purity of the products throughout the entire supply chain. MULTIVAC has been offering packaging machines for many years that enable safe packaging of sterile and medical devices in cleanrooms.

“We can draw on many years of experience gained in our in-house cleanroom and continuously expand it,” reports Heinz Wegmann, project manager and specialist for cleanroom applications in the MCP (Medical, Cosmetics, Pharmaceuticals) business area at MULTIVAC. “Therefore, customers at the Wolfertschwenden site can carry out initial sampling, certified tests, and FATs, i.e., machine approvals, under original production conditions in the cleanroom. Additionally, they have the opportunity to have supplementary systems and components of their packaging solutions, such as printers, tested for their cleanroom suitability. Experienced specialists perform detailed measurements, based on which the solutions are evaluated and, if necessary, optimized.”

The cleanroom in Wolfertschwenden meets the requirements of ISO class 5. “Cleanroom class 5 means that one cubic meter of air contains a maximum of 832 particles with a size of one micrometer,” explains Heinz Wegmann. For packaging medical technology products, cleanroom classes 7 or 8 are usually sufficient, where a 100- or 1000-fold higher number of particles per cubic meter of air is permitted.

Initial sampling and FATs in the cleanroom

For conducting the tests, MULTIVAC brings the respective machine into the cleanroom and measures emissions during the packaging process. The measurements are carried out under production conditions, meaning the same materials and tools used later in the production environment are employed. “The assessment of cleanroom suitability relates not only to the machine but also to the packaging process. It is important that emissions during packaging remain low,” justifies Heinz Wegmann. As soon as products, packaging materials, and machine parts move, friction forces occur, inevitably releasing particles.

During the tests, MULTIVAC examines numerous parameters together with the customer under various operating conditions of the machines, so that the influence of packaging materials and different process steps can be described more precisely. Based on these results, the packaging solution can be optimized if necessary.

Cleanroom-compatible packaging machines

MULTIVAC itself uses the cleanroom to investigate particle formation and particle emission in newly developed machines and lines. The packaging specialist’s portfolio includes several cleanroom-compatible models, in which the results of cleanroom measurements have been incorporated into their development: various thermoforming machines can be designed for cleanroom conditions, including the Traysealer T 260 and chamber machines with permanently heated sealing bars (TC series), which are suitable for use in cleanroom environments. The results of these tests not only serve to further develop and optimize packaging solutions but also contribute to configuring customized packaging solutions.

To reliably and efficiently meet the individual requirements of customers, the expert team also offers a wide range of supporting services. This includes a qualification and validation package that complies with GMP, GAMP5, and ISO guidelines. Upon request, MULTIVAC also supports qualification and validation processes on-site or assists in creating special validations and retrospective validations of already installed packaging solutions. The service offerings include not only cleanroom testing but also comprehensive project management, worldwide customer service, and training courses at the Training & Innovation Center in Wolfertschwenden or on-site at the customer’s location.