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WATER TREATMENT PLANT Date:
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Document No.:
DESIGN QUALIFICATION
REPORT
ON
WATER TREATMENT
PLANT
FOR
Document No.:
BY
D/Q
This document is prepared by the Documentation team of Hyaline Aqua Solutions Pvt. Ltd
the treatment of water for M/s. PEGASUS FARMACO INDIA PVT. LTD. Hence, this
document before being effective shall be approved by Pegasus Farmaco Pvt. Ltd
Document Prepared: M/s. Hyaline Aqua Solutions Pvt. Ltd.
Document No.:
Checked By
Reviewed By
Approved By
TABLE OF CONTENTS
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12 DOCUMENTATION 34
13 ABBREAVIATIONS 34
14 ANNEXURES 35
15 REFERENCE DRAWINGS 35
INTRODUCTION:
This document written by Hyaline Aqua Solutions defines the complete design of the
water treatment system requested by Pegasus Farmaco India Pvt. Ltd as out lined in
Pegasus Farmaco Purchase Order No. :
The design qualification also acts as a reference for the programming & subsequent
testing of the system as well as basic document for the validation activity.
OVER VIEW
General Guidelines
Objective
To design the system in conjunction with the design data in order to provide
basis for the vendor and the supplier to design and fabricate the system
(Equipment and Components) to meet design intend to ensure that user
requirement specifications are achieved.
References
This project shell be executed in accordance with the guidelines laid down in
cGMP.
Purpose
To design the Water Treatment system considering that it should treat the Bore
well water with a TDS of not more than 1500 ppm..
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The Water treatment system shall be designed and constructed to meet all
requirements of current GOOD Manufacturing Practices (cGMP’s)
Acceptance Criteria
The out put water from Demineralizing Treatment design shell confirm to
ordered specification.
All the parameters must be proved & sustained by documents or conformed
by appropriate tests.
All the documents supplied by Hyaline Aqua Solutions.
Safety
Upon loss of electrical power, all the components fall into “SAFE” position.
Upon restoration of electrical power, Ambient Air Supply & Distribution and
Exhaust shall not start automatically. An input from the operator shell be
required to restart the system. No additional action shell be required for full
recovery after an electrical failure.
cGMP Compliance
Following basic features should be incorporated in the system design to make it
cGMP complaint.
1. Primary Treatment:
1. Microbial should be < 100 cfu/ml.
2. Residual chlorine content – Nil
3. Turbidity <2NTU
4. Water PH in between 5 – 7.
2. DM Water Treatment:
1. Microbial should be : NMT 100 cfu/ml.
2. Residual chlorine content – Nil
3. Turbidity – Nil
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M/s. Pegasus Farmaco India Pvt. Ltd is responsible for the following:
To check and verify all the documents submitted as per above are in line with agreed
specifications, scope, and shell approve all the documents to signify that the vendor
has complied with his commitment.
To provide the necessary site clearance and complete the site activities covered in
M/s. Hyaline Aqua Solutions Pvt. Ltd.
Ensure that all the utilities and material required for the commissioning of system as specified
by Hyaline Aqua Solutions Pvt. Ltd in design qualification and other documents are made
available.
Carry out validation activities after the plant is certified for intended operations.
M/s. Pegasus Farmaco India Pvt. Ltd
On behalf of M/s. Pegasus Farmaco India Pvt. Ltd, following team is authorized to
approve all the qualification protocols. Such approval of qualification documents shall be
deemed acceptable by M/s. Hyaline Aqua Solutions Pvt. Ltd and shall be considered as
suppliers complying with his commitment of contract obligations.
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Checked By
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Water as it occurs in nature “pure” and whatever be the source, always contains
impurities either in solution or in suspension. The determination of these impurities
makes analysis of water necessary and removal and control of these impurities
make water treatment essential.
Water Sources
a) Rain Water
Of the above, logically, rain water is the purest but even this collects and dissolves
atmospheric gases and impurities in air. Further, once in contact with the earth’s
crust, the rain water will gradually dissolve various materials.
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1) Non-ionic Impurities
These are mainly turbidity, salt, mud, dirt and other suspended matter; micro-
organisms, bacteria and other organic matter, oil and
corrosion products. It goes without saying that drinking water and most
industrial water supplies should be clear and organic - free.
Any salt which dissolves in water disassociates into positively charged ions called
Cations and negatively charged ions called Anions. Since these permit the water to
conduct electricity, these salts are called electrolytes.
Calcium, Magnesium, Sodium and Iron, and rarely Ammonium, Potassium and
Manganese. These Cations are associated with Anions like Bicarbonates,
Carbonates, Hydroxides (the sum of which is termed as Alkalinity), Sulfates and
Chlorides. Presence of Nitrates and Phosphates is normally not very common. In
the water treatment field, the preferred method of expression of these dissolved
impurities is in terms of Equivalent Calcium Carbonate, abbreviated to “as CaCO3”.
This is because Calcium Carbonate is a good common denominator as it has a
molecular weight of 100, which facilitates calculations.
Moreover, in this form of analysis, the sum of Cations or total Cation always equals
the total Anions. Quantitatively, these are expressed in parts per million or
milligrams/litre. One part per million equals one ten thousandth of one percent
(0.0001%).
One part per million means one part in a million parts, for example, one litre in a
million litres of water or one Kg. in a million Kgs. of water.
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3) Gaseous Impurities
Of the atmospheric gases found in naturally occurring waters, only two, Carbon
Dioxide and Oxygen, are the main causes of many corrosion related problems.
The major concern in industrial water treatment, where the water used directly or
indirectly in an industrial process, is to treat the water to be suitable for that particular
application/process. Depending on the process, varying degrees of purity of treated
water are required. For example, a textile processing unit will require soft and clear
water for process use; a chemical plant will require pure water for process not
exceeding 1.0 mg/litre of dissolved impurities or electronic components
manufacturing unit require ultra-pure water containing total dissolved impurities not
exceeding 0.5 mg/litre or less. So depending upon the requirement, various water
treatment processes are adopted to treat the water, to make the water suitable for
that particular application. The details of the processes are as follows:
FILTRATION
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Filter media commonly employed are graded and washed sand of effective size 0.35
mm to 0.50 mm resting on a supporting under bed of crushed gravel and pebbles of
four varying sizes, with the coarsest size at the bottom of the bed. The sand depth
is 500mm and the under bed depth also being 500mm.
The major components of a Pressure Filter are a steel pressure vessel with dished
ends (normally vertical and cylindrical, though for larger flows horizontal and
cylindrical vessels are employed); internals comprising raw water distributor and
filtered water collector-cum-backwash water distributor; external pipe work and
valves; filter media and instruments like pressure gauges, flow indicator etc.,
Backwashing of the filter bed has to be carried out periodically (normally once in 24
hours, more frequently if the pressure drop across the bed exceeds 0.7 Kg/cm and
which indicates accumulation of dirt in the bed) with filtered water at a minimum head
of 10 MWC. For large filtration flow rates air agitation facilities are provided then the
backwash rate can be reduced. The normal backwash time is 5-6 minutes and the
scour time 2-3 minutes.
Normally Filters should not be fed with water carrying suspended matter and
turbidity content of more than 30 to 50 NTU. Above these limits the water should be
settled and clarified before Filtration. Also to increase the efficiency of Filtration and
to ensure that even fine Suspensions are removed, the usual practice is to dose
Coagulant Chemicals like alum, ferrous sulfates or sodium aluminates at the inlet to
the filter by means of a mechanical type doser or a metering pump. in the case of a
hot lime softener plant effluent. Activated Carbon is used as a filtering Medium when
oil/chlorine removal, etc., are required. A layer of processed Manganese Dioxide is
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incorporated in sand Filters for Iron Removal. A layer of anthracite once the sand
bed enhances the filtering capacity by providing in-depth filtration. When anthracite
is used for filter can handle turbidities of up to 100 NTU.
Cl 2 +H2O 2HCl + ½ O2
This is the method used for dechlorination of water subjected to excess chlorination
treatment
Cation Exchanger:
Cations are ions that carry a positive electric charge, typical Cations are Calcium,
Magnesium, Sodium, Iron, Copper,, Gold, Hydrogen etc
As water passes through the Cation exchanger it encounters millions of resin beads
each of which contains a large number of negatively charged exchange sites in the
pores and microscopic paths of it structure when the resin is in the regenerated state
each exchange site is occupied by a positively charged hydrogen ions as the
positively charged Cations in the water contact the beads they are attached to the
negative exchange sites. Since they are stronger in their positive charge then the
positive hydrogen ions they drive off the hydrogen ions and attach to the exchange
sites by doing, they maintain the balance between the positive and negative charges.
Since the hydrogen ions are acidic this exchange can also be described as
displacement of acid ions. The water at the outlet of Cations is dilute mineral acid.
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Anion Exchanger
Anions are ions that carry a negative electrical charge, typical anions are chlorides,
sulphate, nitrates, carbonates Bio-carbonates, hydroxides etc.
The anion exchange process is similar to the Cation exchange process, The anion
resin is made of resin beads which have positive exchange sites and when
regenerated with NaOH are occupies by negative Hydroxide ions (OH) as the
negatively charges are the non-metallic anions contact the beads the same
attraction-repulsion process takes place and the negative hydroxide ions are
dislodged and replaced by the stronger negative non-metallic ions.
Anion resin is produced from the styrene and divinylbenzine but contains quaternary
ammonium groups these synthetic organic resins are designed to exchange or
adsorb specific or all anions from water including silica and carbon dioxide. The PH
will be typically between 7.2 and 9.
Mixed Bed
Mixed bed differ from the individual Cation and anion bed system as mentioned
above the Cation and anion resins are used separately in their respective vessels
whereas in the mixed bed the two resins namely Cation and anion are arranged side
by side in a single vessel and are intimately mixed by agitation with the help of
compressed air, the whole bed behaves like an infinite number of anion and Cation
exchangers in series.
To carry out regeneration the two resins are separated by decompacting them with a
stream of water. As the anion resin is lighter, it rises to the top while the heavier
Cation resin falls to the bottom.
After separation each of them is regenerated separately the anion portion with
caustic soda and the Cation with a strong acid. The resins are washed and remixed
with compressed air
The water obtained is of very high purity and remains constant throughout the cycle.
The pH is almost neutral the rinsing water consumption is very low . The mixed bed
has a very low exchange capacity and hence this should always precede after the
anion unit . The inlet water to Mixed Bed should be less than 30 micro siemen / cm.
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The final mixed water before use in any industry is disinfected and for this purpose
ultra violet system is used .
The ultra violet radiation is emitted by very low pressure mercury vapour lamps, the
power rating of which may be as much as 200 watts and whose average life is 3000
hours. The wave length lie in the 200 – 300 nm range [ 2000 – 3000 angstrom units]
with a maximum microbicidal action around 250nm.
The water to be treated is usually pressurized and filtered for removal of suspended
impurities or turbid matter that can take place due to reagents used for regeneration
of exchangers. The presence of turbid matter or suspended solids reduces the
transmittance and hence the water should be perfectly clean.
The water is made to flow through a pipe at the center of which is located a quartz
tube accommodating the radiation source. In this way the thin layer of water is
exposed to the germicidal action of the rays
5 Micron filter:
In this process, the water passes through 5 Micron Cartridge to avoid impurities NLT
5 micron in size.
The user requires 30,000 liters of De- mineralized water with a conductivity less than
1 micro Siemens/ cm. The source of water is from the Bore well
The Bore well Water Characteristics, as furnished by the user M/s Alkaloids pvt ltd,
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pH : 6.5 - 9.5
Conductivity : < 30 Micro Siemens/cm
Silica : < 0.5 ppm as SiO2
pH : 6.5 - 7.5
Conductivity : < 0.5 Micro Siemens/cm
Silica : < 0.1 ppm as SiO2
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PUMP
ANTISCALENT DOSING
PUMP
CATION
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ANION
MIXED BED
TO SS STORAGE TANK
PROCESS CALCULATION
Since 30,000 liters of D.M. Water is required Net at the outlet of Mixed bed unit:
36 x 75
= 60 liters of Cation resin is required.Actual quantity used is 100 Liters.
45
The resin manufacturers suggest a minimum bed depth of 700 mm for all
exchangers to get sufficient contact time and effective performance.
Considering surface flow rate and velocities we have selected 330 diameter vessel
with 1250 mm height so as to accommodate the above resin . The volume of the
above vessel shall be 106.8 liters, the cation resin expansion is 7% and hence the
cation unit shall be filled with 99.3 liters of Duolite C-20 H as the unit is a packed
bed.
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34 x 75
= 91 liters of Anion resin is required.
28
The volume of the above vessel shall be 106.8 liters, the Anion resin expansion is
12% and hence the Anion unit shall be filled with 94 liters of Duolite A-116 resin as
the unit is a packed bed.
For the calculation of Mixed bed unit preceding packed bed cation and Anion the
velocity should not exceed 50 m/hr as the flow required is 3 M3/hr and a maximum
flow of 5 M3 the calculation would be
2 M3/hr
= 0.07 M2 The diameter of 300 mm vessel is suitable since the
50 M/hr surface area is 0.07065 M2
The average bed depth should be 500 mm in general the ratio of Cation to anion is
1:1 or 1:1.5 etc in our case the ratio is 1;1 due to few factors and considering the pH.
The Mixed bed unit is an polishing unit and brings the pH to neutral The Mixed bed
regeneration is slightly complicated and has to be regenerated carefully. The unit
has to be regenerated only once in 7 days and if the silica slippage is less than the
above the unit will produce much more than the rated output. To monitor the M.B unit
an on line conductivity measurement at the outlet is the best solution hence an on
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EQUIPMENT SPECIFICATION:
MODEL : MMF
MOC : FRP
Diameter – mm : 330
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MODEL : HACF
MOC - : FRP
Diameter – mm : 330
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Model : AOF-5
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No. of Membranes : 2
Salt Rejection % : 95 %
MODEL : HSAC
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MOC - : FRP
Diameter – mm : 330
Make : Hyaline
Size : 300x2000
Numbers : ONE
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Type : Diaphragm
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Diaphragm : Neoprene
Spindle : SS-410
Size : 25NB
Supplier : Hyaline
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Particle Density
Uniform Coefficient
Hardness Number : 98
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CATION RESIN:
% Moisture in H Form : 47 – 53
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Regenerant : HCL
Injection Strength : 5%
Preparation : 10%
ANION RESIN:
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Regenerant : NaOH
Injection Strength : 5%
Preparation : 10%
Mixed bed unit contains both Anion Resin and Cation Resin
CATION RESIN:
Name of the product : CATION
% Moisture in H Form : 47 – 53
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Regenerant : HCL
Quantity of Regenerant : 3 Kg
Injection Strength : 5%
Preparation : 10%
ANION RESIN:
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Regenerant : NaOH
Quantity of Regenerant : 3 Kg
Injection Strength : 5%
Preparation : 10%
Make : Hyaline
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2
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SYSTEM CONTROL
Control the system by manual operating the push buttons whenever system is
required, one inter lock is provided for safety aspect.
UTILITIES
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The entire plant is erected and installed to fulfill the cGMP requirement for
Water Supply, which are mentioned in point 2.2.
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Testing
Turbidity
Lab
Residual Chlorine
Lab
Microbial
Lab
Conductivity
On line conductivity meter
TOC
Lab
Pathogens
Lab
Motor Load
Motor load to be checked with Tong tester /Digital Multi meter.
Identification
Whole system will be tagged. The tag number will be follow the numbers
of P & I diagram.
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CLEANING
The whole system cleans by run the system 4 hours with filter water.
SUPPLIER
Refer to attached list of components, Annexure – 1, for the details of equipments and
Instruments vendors and technical specifications for the same.
DOCUMENTATION
After Design Qualification approval, Installation Qualification and Operational
Qualification will be prepared by Alkaloids pvt limited with the successful installation
and commissioning of the system. These documents will be supported with following
details.
12. ABBREVIATIONS
1. DQ : Design Qualification
2. Mts. : Meters
3. NTU : Nephelometric turbidity unit
4. TOC : Total organic carbon
5. PPM : Parts per million
6. FLP : Flame Proof
7. NFLP : Non Flame Proof
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13. ANEEXURES
02 GA Drawing of DM Plant