farmacie-leky

COMPAS automation solutions meet the demands of the regulated pharmaceutical and cosmetic industries. We support batch production (recipe and batch systems), special design for clean rooms, design for environments with the risk of explosion, good engineering practices including preparation of documentation according to GMP and GAMP.

The delivered control systems support the requirements of operation for process control, change logs (e.g. operator’s interventions during production), production quality control and electronic records on production (EBR, operating sheet, batch run) and batch documentation.

 

We have experience in automation of production equipment for solid pharmaceuticals, in the process of storage, weighing, homogenization, fluid drying, tablet pressing, tablet coating and adjusting, liquid pharmaceuticals; with the process of weighing, formulating, filling, sterilizing, lyophilisation as well as semi-solid pharmaceutical ointments and suppositories, including the process of labelling and packaging. The processes also include cleaning and sterilization systems CIP / SIP.

We implement projects in compliance with the principles of GMP. If client is interested, we also provide validation activities and documentation, usually in the scope of IQ, OQ qualification.

COMPAS automatizace supports both printed or hybrid form of the production documentation as well as fully electronic production documentation in compliance with the requirements for protection of records and electronic signatures according to FDA and 21CFR Part 11.

COMPAS solution provides communication or integration with production IT systems, such as MES, WMS, LIMS and ERP.

Long-term support and service are provided according to the Client’s requirements; we can also offer engineering for change procedures related to, for example, introduction of new products and preparation of related documents.

Some of the projects we have implemented are: automation of the weighing room, process technologies, tablet press, homogenization machine, fluid dryer, tablet coating machine, adjusting line, formulation boilers, injection fillers, lyophilisation machine, labelling machine and packing lines. Many projects have been implemented for control over purified water production (PW, WFI, and so on) and related stocking, distribution and dispensing.

The automation of pharmaceutical plants also includes measuring and regulation systems for auxiliary operations, such as boilers, cooling equipment, HVAC control, media production and distribution etc.

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