This article outlines the different types of water used in pharmaceutical industry and their uses
1.0 Introduction
Pharmacopoeias include the specifications for different types of water used in pharmaceutical industry. Companies who supply water to different markets should meet the specifications given by the pharmacopoeias of the relevant market.
1.1 Different Types of Water
1.1.1 Purified Water
It is used in production of non- parenteral preparations as excipient and in cleaning of equipments and other components
It is used for all tests and assays unless specified to use other type of water
This water should be free from microbial contamination and should meet the specifications mentioned for ionic and organic chemical purity.
Drinking water is the source for production of purified water by purifying using unit operations like deionization, distillation, filtration, ion exchange, reverse osmosis.
Purified water should be validated to obtain consistency in terms of chemical and microbiological quality.
Under ambient conditions biofilms can be established on purified water which can source endotoxins or microorganisms
1.1.2 Sterile Purified Water
It is the purified water that is packaged and rendered sterile.
It is used to prepare nonparenteral compendial dosage forms or any analytical applications which require purified water where validated purified water system is not practically accessible or only small quantity of water is needed or sterile purified water is required or bulk packaged purified water is not microbiologically controlled
1.1.3 Water for Injection
It is used as an excipient for parenterals production, preparations where content of endotoxin should be controlled and in cleaning of equipment and parenteral product contact components.
The minimum feed water or quality of source for producing water for injection is given by US EPA, Japan, WHO and EU. This source water should be pretreated to be suitable for further distillation or any other validated process.
The water obtained as the final product should meet all chemical requirements and bacterial endotoxin specifications for purified waters.
Water for injection should be validated to produce consistent quality
1.1.4 Sterile Water for Injection
It is the water for injection which is packaged and rendered sterile
It is used as sterile diluent for parenteral products and for extemporaneous prescription compounding.
It may be used for applications where bulk water for injection in indicated or where validated water system is not practically accessible or only small quantity of water is needed.
It is packaged in single dose containers which are not larger than 1L in size.
1.1.5 Bacteriostatic Water for Injection
It is sterile water for injection to which one or more suitable antimicrobial preservatives are added.
It is used as diluent for preparing parenteral products particularly multi dose products which require continuous content withdrawals.
It should be packaged in single dose or multiple dose containers which are not larger than 30mL
1.1.6 Water for Hemodialysis
This water is used for hemodialysis mostly for dilution of hemodialysis concentrate solutions.
It is produced from EPA drinking water and used on site. Further it is purified to reduce microbiological and chemical components.
It should be packed and stored in unreactive containers to limit any bacterial entry.
This water is not intended for injection and doesn’t contain any added antimicrobials
1.1.7 Pure Steam / Clean Steam
Pure steam is used where steam or its condensate contacts article contact surfaces or official articles during their sterilization, preparation and cleaning where no further steps are required to remove any impurity residues.
1.1.8 Sterile Water for Irrigation
It is water for injection which is packaged and sterilized in single dose containers which in size are larger than 1L and permit fast delivery of contents.
It is not mandatory to meet the requirements for small volume injections.
It is used for applications which don’t have particulate matter specifications or where purified water or water for injection is indicated but access to the validated water system is absent or larger quantities for sterile water for injection is needed.
1.1.9 Sterile Water for Inhalation
It is water for injection which is packaged and sterilized and is used in inhalators and preparation of inhalation solutions.
It is not suitable for parenteral applications as it carries less stringent specifications for bacterial endotoxins than sterile water for injection.
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