High Containment Processes in the Solid Drugs Production

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DÜPERTHAL Sicherheitstechnik GmbH & Co. KG

The Production Environment

Any containment is incomplete where the protective effects end at the supply limit of the process equipment. That is why a system solution also focusses on the design of the production environment. When processing highly active solid materials, material/personnel logistics, conditioning of operating media and room ventilation are relevant, for example.

Material and personnel routs are designed so that regulatory requirements for solid drugs on the protection against contamination and confusion are met. By a vertical product flow, it is possible to transfer solid drugs in an enclosed manner.

There are 5-chamber air-locks with separate entries and exits upstream of the production rooms. Container sizes and measures for surface decontamination determine the air-lock size.

The dimensions of the production rooms depend on the capacity of the production facility and the space required for the protective equipment. When using two-disk containment valves, sufficient space is required on the charging or discharge port for centring and docking movements of the valve halves.

Areas for the preparation of operating media depend on the consumption rates and required quality parameters. A sufficient supply of water is required for process equipment cleaning to prevent the capacity of cleaning equipment from being restricted. Total loss cleaning is used when processing highly active solid drugs. Lower limits for cleaning residues must be met compared to standard products.

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