Water for Pharmaceutical Use

Water for Pharmaceutical Use;- Introduction. One of the main resources the pharmaceutical business uses is water. It is extensively utilized in the processing, formulation, and production of pharmaceutical goods, active pharmaceutical ingredients (APIs) and intermediates, and analytical reagents as a raw material, ingredient, and solvent.

All medications that contain water are prepared using purified water, with the exception of ampoules, injections, and few official external preparations like liniments. Ionic and organic chemical purity standards for purified water must be met, and it must also be shielded from microbiological contamination.

Water for Pharmaceutical Use

Types of Water for Pharmaceutical Use

1. Water is a widely used substance, raw material in the production, processing and formulation of pharmaceutical products
2. Impurities present in water may contaminate or react with intended product substances, resulting in hazards to health
3. Control of the quality of water throughout the production, storage and distribution processes, including microbiological and chemical quality, is very important
4. Assurance of quality to meet the acceptable standards of pharmaceutical products is essential
5. 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
6. 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.
• 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.

1. Portable water
2. Purified water
3. Water for preparation
4. 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 g. springs, wells, rivers, lakes and the sea
• The condition of the source water will dictate the treatment required to render it safe for human consumption (drinking)
• 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

Key Points 

• Production and uses of Water for pharmaceutical use should follow the requirements specified by Pharmacopoeias and other requirements by international and local authorities.

References

• Eshuis J., & Manschot, P (1992).Communicable diseases, (1^sted). 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 (4^thed). 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