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ION EXCHANGE DEIONIZERS |
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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. |
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CONSTRUCTION
CHARACTERISTICS AND PROCESS COMPONENTS
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ion exchange columns are manufactured in carbon steel with
ebonite convering. |
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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. |
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The process
pneumatic valves are membrane type in plastic material. |
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The plant is
preassembled on suitable skids for easy reassembling after
positioning. |
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- The
interconnecting and recycling piping between the ion
exchange columns is in high resistance food grade PVC. |
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- The
hydraulic line after the columns is in AISI 316 L stainless
steel mirror polished. All welds are by automatic orbital
machine |
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- Suitable
recycling lines are provided to maintain all the plant
sections in circulation, during the stand-by phases. |
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TYPICAL CONFIGURATION OF EXCHANGE
DEIONIZERS |
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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 |
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DOCUMENTATION
The Documentation
Package supplied by STILMAS for its Plant is conceived and
organized to be in compliance with the following
requirements: |
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To provide documented evidence of the Project Life-cycle,
from the design phase up to the final Site Acceptance Test
runs |
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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. |
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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. |
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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. |
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