High Containment Processes in the Solid Drugs Production

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DÜPERTHAL Sicherheitstechnik GmbH & Co. KG

In the high containment area, CIP-capable granulation systems (SC SuperClean Design) are used. Because of their design, metal filters for internal product retention need more cleaning solution than textile filters. The supplier of the granulation equipment knows the consumption from cleaning trials. Results from such trial runs are used in engineering as design aids. In case of lower containment requirements, combinations from WET and WIP cleaning are possible.

Waste water from the cleaning contains solid matters and needs to be collected and decontaminated afterwards. Waste water runs which are only used occasionally may become emission sources for highly active solid materials if they are not dust-tight.

Exhaust air from process equipment contains highly active product dusts and is conveyed via HEPA filter systems. It must be possible to change contaminated filters via a Safe Change filter system and the filters need to be equipped with connections for wetting and cleaning.

The process dedusting equipment often controls the pressure for the containment of the process equipment. Technical areas have to accommodate continuously operating process dedusters with volume flow control and closed dust discharge. Intake air for process dedusting is drawn from the production room via HEPA filters. The correct adjustment of the room pressure, fresh air proportion and the selection of the filter quality, requires a close coordination with the designer of the ventilation and air conditioning systems.

Integral Solution in the Focus

For a complete containment, process equipment and production environment need to be combined to an integral solution. This requires the consideration of technical and regulatory specifics. Suppliers of process equipment can meet and prove the highest containment requirements. In particular in the high containment area, process competency and project experience are required for an efficient containment solution.

* The author is Project Engineer with Glatt Ingenieurtechnik.

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