Introduction to pharmaceutical

water system

Prepared By: Magdy Abdelraheem

Introduction why water ?

Water is the most widely used substance, raw

material or starting material in the
production, processing and formulation of
pharmaceutical products.
It has unique chemical properties due to its
polarity and hydrogen bonds.
This means it is able to dissolve, absorb, or
suspend many different compounds.
Introduction why water ?

Control of the quality of water throughout

the production, storage and distribution
processes, including microbiological and
chemical quality, is a major concern.
Sections of purified water system

1- Pretreatment section
2- Desalination section
3- Storage and Distribution section
Pretreatment section & System Design.
1) Drawing of P&ID
2) Purified water Chemical and microbial Limits.
3) Design of Purified water system.
1) Pretreatment section
A. Feed water quality
B. Chlorination system
C. Ultra filtration unit
D. Automatic Softeners duplex
E. Carbon filter
F. Depth filter selection
1- What is P&ID means?

A piping and instrumentation diagram (P&ID) is a

detailed diagram in the process industry which shows the

piping and vessels in the process flow, together with the

instrumentation and control devices.

What P&ID can Covering ?
Piping and Instrumentation Diagram (P&ID)

 For Equipment—Show Every Piece (spare units, parallel units,

summary details of each unit)
 For Piping—Include All Lines (drains, sample connections and
specify size (use standard sizes), materials of construction,
insulation (thickness and type)
 For Instruments—Identify indicators, recorders, controllers
 For Utilities—Identify entrance utilities, exit utilities, exit to waste
treatment facilities
2- Purified water Chemical and
microbial Limits.

Chemical limits Microbial limits

USP vs BP / EP
Suggested bacterial limits (CFU /mL)(WHO ,2005)

Sampling location Target Alert Action

 
Raw water 200 300 500
Post multimedia filter 100 300 500
Post softener 100 300 500
Post activated carbon filter 50 300 500
Feed to RO 20 200 500
RO permeate 10 50 100
Points of Use 1 10 100
3- Design of Purified Water System
 Factors to consider:
 Feed water quality and required water quality
specification
 Sequence of purification stages needed
 Energy consumption, extent of pre-treatment
needed
 Location and design of sampling points
 Appropriate instrumentation for measurements
 Sanitization mode of each sections
Design of Purified Water System

 General consideration should be discussed before selection a

PWS.
 Design qualification (Determine User requirement of
PWS).
 Check the optimum position of water system in the
factory.
 Check the routine chlorine dose in city water.
 Hardeness tester
Nac
7m3 l
tank
7m3 2m3
Cl2 sensor

Cl2
inj.

FIT

PH meter Cl2 sensor

Sw
1m3
1 st
permeate
Naoh
Conduc. meter 1 st RO inj. 10 µm filter

UV lamp

Pump

2 nd RO H/C heat exc.

8m3
1m3 5 µm filter
Pretreatment section & System Design.
1) Drawing of P&ID
2) Purified water Chemical and microbial Limits.
3) Design of Purified water system.
1) Pretreatment section
A. Feed water quality
B. Chlorination system
C. Ultra filtration unit
D. Automatic Softeners duplex
E. Carbon filter
F. Depth filter selection
Pretreatment section of
Purified Water System
A- Feed water quality
 Before selection the pretreatment unit You must know
the following :
A- Total Dissolved solid (TDS)
B- Total suspended solid (TSS)
C-Total Hardness
D- Slight Density index (SDI)
E- Microbial count
F- Free Chlorine
G-Total Organic carbon (TOC)
B- Chlorination system :
 Dose of sodium hypochlorite to reduce bacterial load
B- Chlorination system :
 How does sodium hypochlorite disinfection work?

 When dissolved in water, chlorine converts to an equilibrium mixture of

chlorine, hypochlorous acid (HOCl), and hydrochloric acid (HCl):
Cl2 + H2O ⇌ HOCl + HCl

 Hypochlorous acid is divided into hydrochloric acid (HCl) and oxygen (O).

The oxygen atom is a very strong oxidator.

 Sodium hypochlorite is effective against bacteria, viruses and fungi. Sodium

hypochlorite disinfects the same way as chlorine does.
 A- Chlorination system :
 Total chlorine = combined chlorine + free chlorine

 The chloramines ,along with other chlorine compounds are referred to

as combined chlorine residuals or combined available chlorine.

 Chlorine ,hypochlorous acid and chlorite ion are collectively referred to

as free chlorine residuals or free available chlorine.

 Limit of free chlorine between 1-3 PPM the NaOCl is injected by

dosing pump and monitoring by online chlorine analyzer
C- Ultra filtration unit

is a physical process by separating colloids ,

impurities and materials with high molecular

weight particles across membranes with their

pores ranging in size from 0.1: 0.03 microns.

C- Ultra filtration unit

 MODULE FEATURES

 The Ultrafiltration modules are made from high strength, hollow fiber membranes .

 0.03 μm nominal pore diameter for removal of bacteria, viruses, and particulates

including colloids.

 PVDF polymeric hollow fibers for high strength and chemical resistance.

 Hydrophilic PVDF fibers for easy cleaning and wettability that help maintain long

term performance.
C- Automatic Softeners duplex
 Water softeners are specific ion exchangers that are designed to remove calcium
(Ca++) and magnesium (Mg++), positively charged, with other ions, for instance
sodium; sodium cannot form scale because it is much more soluble
 To soften water, is necessary to pass the hard water through a column filled with
the cation exchange resin (polystyrene) in sodium form.
 The hardness ions Ca++ and Mg++ move into the resin beads and each of these
divalent cations is replaced by two sodium ions getting out of the resin.
 The exchange reaction can be written as:

The softened water hardness limit not more than 5 ppm.

Softener Regeneration
 Regeneration of ion exchange resins is a reversal of the exchange reactions shown
above.
 The softening resin is regenerated with sodium (Na+) ions supplied by a salt
(NaCl) solution. The regeneration reaction is:

 The regeneration process can be repeated indefinitely without damaging the resin.
 The regeneration cycle of a softener consists of four steps: backwash,
regeneration (brining),displacement (slow rinse), and fast rinse.
D- CARBON FILTER
 Activated carbon filters remove chlorine injected to prevent
oxidation of reverse osmosis (RO) membranes

 C* + 2 Cl2 + 2H2O  4 HCl + CO2

 More over activated carbon filters remove / reduce many

volatile organic chemicals (VOC), pesticides and herbicides,
benzene trihalomethane (THM) compounds, radon, solvents
and hundreds of other man-made chemicals found in tap
water.
D- CARBON FILTER
 There are two principal mechanisms by which activated
carbon removes contaminants from water,

1- Adsorption using to remove Organic compounds such as VOC

2- Catalytic reduction using to remove residual disinfectants such

as chlorine and chloramines

3- The limit of free chlorine after carbon filter is NMT 0.1 ppm
D- CARBON FILTER
The advantages of carbon filters are
(1) Its ability to remove organics from feed water that could foul the RO.
(2) That they are more reliable in treating all the feed water than a chemical feed
system , safe to control what that means? .
The disadvantage to using carbon filter (adsorber)s is that:
(3)Carbon filters have been known to see a doubling of viable bacteria counts in 24
hours (high nutrient carbon capacity ) .
(4)Infection can be occur as frequent as 5 to 15 days.
(5)So, They are high probability bacteria growth which can result in biological
fouling of the RO.
cartridge filter

 a cartridge filter of 10 μm to hold any residual particles

contained in the softened water (for example resin grains &

carbon dust and many leak from column distributers in

pretreatment plant.

 Using absolute cartridge filter with performance 99 %

 Feed water after pretreatment section should be with

the following specs :

 Free chlorine zero ppm

 Hardness less 5 ppm

 SDI less the 3

Any Questions

Thanks