NTA Level 4 • Semester 1 • PST04102

Water for Pharmaceutical Use

Disease Control and Prevention • Source Session/Topic 9

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Session 9: Water for Pharmaceutical Use

Total Session Time: 60 minutes + 2 hours Assignment

Prerequisites

• None

Learning Task

By the end of this session students are expected to be able to:

• Describe Types of Water for Pharmaceutical Use

Resources Needed:

• Flip charts, marker pens, and masking tape

• Black/white board, chalk and whiteboard markers

• Computer and LCD Projector

SESSION OVERVIEW

SESSION CONTENTS

STEP1: Presentation of Session Title and Learning Task (5 minutes)

READ or ASK students to read the learning tasks and clarify

ASK students if they have any questions before continuing

STEP 2: Types of Water for Pharmaceutical Use (40 minutes)

|Activity: Small Group Discussion ( 20 minutes) |

| |

|DIVIDE students into small manageable groups |

| |

|ASK students to discuss on the following question |

|What are the types of water for pharmaceutical use? |

| |

|ALLOW students to discuss for 10 minutes |

| |

|ALLOW few groups to present and the rest to add points not mentioned |

| |

|CLARIFY and SUMMARIZE by using the contents below |

• Water is a widely used substance, raw material in the production,

processing and formulation of pharmaceutical products

• Impurities present in water may contaminate or react with intended

product substances, resulting in hazards to health

• Control of the quality of water throughout the production, storage and

distribution processes, including microbiological and chemical quality,

is very important

• Assurance of quality to meet the acceptable standards of pharmaceutical

products is essential

• Microbial contamination in the production of pharmaceutical products can

be minimized by proper designing of the system, periodic sanitization and

by taking appropriate measures to prevent microbial proliferation

• Different grades of water quality are required depending on the route of

administration of the pharmaceutical products (Different grades of water

can be found in pharmacopoeias and related documents)

General principles for pharmaceutical water systems

• Pharmaceutical water production, storage and distribution systems should

be designed, installed, commissioned, qualified and maintained to ensure

the reliable production of water of an appropriate quality.

• The capacity of the system should be designed to meet the average and the

peak flow demand of the current operation.

o All systems, regardless of their size and capacity, should have

appropriate recirculation and turnover to assure the system is well

controlled chemically and microbiologically.

• The use of the systems following initial validation (installation

qualification (IQ), operational qualification (OQ) and performance

qualification (PQ)) and after any planned and unplanned maintenance or

modification work should be approved by the quality assurance (QA)

department using change control documentation.

• Water sources and treated water should be monitored regularly for

chemical, microbiological and, as appropriate, endotoxin contamination.

• There are four types of water used in pharmacy.

o Portable water

o Purified water

o Water for preparation

o Water for injection

Drinking/Portable water

• Portable water is water fleshly drawn from public mains supply

• It does not include water from local storage tank which may be heavily

contaminated with microorganisms

• Portable water is suitable for preparation of pharmaceutical preparation

for internal and external use

• Drinking-water should be supplied under continuous positive pressure in a

plumbing system free of any defects that could lead to contamination of

any product

• Drinking-water is unmodified except for limited treatment of the water

derived from a natural or stored source e.g. springs, wells, rivers,

lakes and the sea

o The condition of the source water will dictate the treatment required

to render it safe for human consumption (drinking)

o Treatment includes desalinization, softening, removal of specific

ions, particle reduction and antimicrobial treatment

• It is the responsibility of the pharmaceutical manufacturer to assure

that the source water supplying the purified water (PW) treatment system

meets the appropriate drinking-water requirements

• Drinking-water quality is covered by the WHO drinking-water guidelines,

standards from the International Organization for Standardization (ISO)

and other regional and national agencies.

Purified water

• This is prepared from suitable portable water by distillation or reverse

osmosis system

• If allowed to stand it may gain a high content of vegetative organisms

• Water for pharmaceutical production must be freshly boiled and cooled

before us

Water for preparation

• Portable or fleshly boiled and cooled purified water is recommended for

preparations of pharmaceutical

• Portable water is suitable only when it is drawn from a public supply

(mains water) and is suitable for drinking

• Water obtained from local storage tank or any other open source e.g.

water from wells is unsuitable for preparation of pharmaceuticals.

• Water for preparation is used for preparation of non-sterile products

such as mixtures.

Water for injections

• This is pyrogen free distilled water or water produced by reverse osmosis

system (ROS) Water for injection is sterilized immediately after

collection and used for parenteral preparation and irrigation in surgical

procedures

STEP 6: Key Points (5 minutes)

• Production and uses of Water for pharmaceutical use should follow the

requirements specified by Pharmacopoeias and other requirements by

international and local authorities

STEP 7: Evaluation (5 minutes)

• What are the types of water for pharmaceutical use?

• What are the uses of each type of water for pharmaceutical use?

STEP 8: Assignment (5 minutes)

|Activity: Take Home Assignment (10 minutes) |

| |

|ASK the students to work individually on the following Assignment |

|Prepare a list of common methods used to treat water in their household|

| |

|ALLOCATE time for students to do the assignments and submit |

| |

|REFER students to recommended reference |

References

Eshuis J., & Manschot, P (1992).Communicable diseases, (1sted). Nairobi:

AMREF

GoT (2004): National Infection Prevention and Control (IPC) Guidelines for

Healthcare Workers. Dar es Salaam: MOHSW

GoT (2013) Standard Treatment Guidelines & National Essential Medicines

List (4thed). Dar es Salaam: MOHSW

Liebsch B., Nyamageni DS., Senya SS., & Steinhausen (1988). Tanzania

Pharmaceutical Handbook.Dar es Salaam: Dar es Salaam University Press

Nordberg, E. (1999): Communicable Diseases, A Manual for Health Workers in

Sub-Saharan Africa, Nairobi: AMREF

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