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ION EXCHANGE DEIONIZERS

The production of pharmaceutical grade purified water by ION EXCHANGE resins is a particular process operation requiring construction criteria and plant configurations able to minimise the growth of microrganisms.
CONSTRUCTION CHARACTERISTICS AND PROCESS COMPONENTS

-  The ion exchange columns are manufactured in carbon steel with ebonite convering.

-  The columns are provided with double flanges with distribution plates and strainers to guarantee the complete wettability of the
    resin beds, avoiding dead legs and uncontrolled contamination growth.
-  The process pneumatic valves are membrane type in plastic material.
-  The plant is preassembled on suitable skids for easy reassembling after positioning.
-  The interconnecting and recycling piping between the ion exchange columns is in high resistance food grade PVC.
-  The hydraulic line after the columns is in AISI 316 L stainless steel mirror polished. All welds are by automatic orbital machine
-  Suitable recycling lines are provided to maintain all the plant sections in circulation, during the stand-by phases.
TYPICAL CONFIGURATION OF EXCHANGE DEIONIZERS  

ADVANTAGES

- The STILMAS experience and technology
   applied in the manufacturing of
   deionizers allow the realization of very
   reliable plants where water quality is
   achieved without the use of sterile
   filtration
- Careful material and component
   selection and the exclusive design
   guarantee high performance, low energy
   consumption and minimum need of
   regeneration chemicals
DISEGNO

DOCUMENTATION
The Documentation Package supplied by STILMAS for its Plant is conceived and organized to be in compliance with the following requirements:

- To provide documented evidence of the Project Life-cycle, from the design phase up to the final Site Acceptance Test runs
- To collect all the necessary information as needed to consistently feed and support the Validation Activity and related Support
   Systems (i.e. Design, Installation, Operational & Performance Qualification, Computer System Validation, Instruments
   Calibration,etc.); to provide to the plant user all necessary information as needed to implement a written and consistent set of
   internal documentation such as Operating & Maintenance S:O:P:s. Preventive Maintenace Program, Periodical Instruments
   Calibration Program, etc.
- To provide to the plant user all necessary information to implement a written and consistent set of internal documentation such as
   Operating & Maintenance S.O.P.s. Preventive Maintenance Program, Periodical Instruments Calibration Program, etc.

VALIDATION
With regard to the Validation Activity, STILMAS is able to provide a fully comprehensive Validation Service Package, including Validation Protocol Preparation, Site Tests execution and Validation Reports organization.
The Validation Activity is performed by a dedicated Validation Team, strongly referenced in the Pharmaceutical Validation Area, which operates in strict coordination with the Project Team.