Increased requirements for the processing of human medicinal products

SMB_Group_Filling_Station-Cleanroom

The requirements for filling systems are constantly increasing. For example, when planning a facility for the production of human pharmaceuticals, special requirements and - depending on the product - legal regulations according to GMP must be considered. (Good Manufacturing Practice). Here, guidelines for quality assurance of production processes and environment are of utmost importance. The production of pharmaceuticals and active ingredients, but also cosmetics, feed, and food products, requires very high quality assurance, as deviations can have direct impacts on consumer health. The GMP-compliant quality management system of SMB International GmbH guarantees product quality and compliance with the mandatory requirements of health authorities for marketing.

For a customer in Hamburg, a semi-automatic filling system was implemented in a cleanroom. The cleanroom was planned and set up by the customer. SMB received specifications for the system configuration, such as the type of sealing material for components in contact with the product with FDA certification, stainless steel piping with a smooth surface, hoses with liners and corresponding FDA approval, connection fittings with dead-space-free transitions such as aseptic flanges and Triclamp.

To approve the system, it was necessary for the system parts to be qualified and validated. This task was carried out by the operator themselves, with SMB providing the documentation. Only in exceptional cases does the company also perform qualification and validation, then with partner companies that specialize in this. "No matter how different the customers' requirements may be, the complete system for each application can be assembled from the variety of coordinated system modules according to customer wishes," adds Andreas Heckel, Managing Director of SMB Group.

As one of the leading companies in the field of filling systems, Koordinatenfüllsysteme produces coordinate filling systems, drum filling systems, canister filling systems, and drum filling lines. Through flexibility in design and close collaboration with individual customers, the company is able to develop and manufacture different solutions according to requirements. "Standard, semi-automatic, and fully automatic filling machines are distinguished," explains Dipl. Ing. Jens Hachmann, Technical Director of SMB Group. "With the latter, an employee only needs to select the stored product data set on the control panel and monitor the machine; everything else runs automatically."