Understanding Water Types in Healthcare: A LacerdaCare Insight.
What's the Difference? Exploring Potable Water, Purified Water USP, and Water for Injection USP
LacerdaCare Journal Newsletter
Author:
Micheal Cardozo, Regd. Pharmacist - (HPOS)-Head of Pharmaceutical Operations & Strategy, LacerdaCare Pvt Ltd.
Product reviewed: Potable Water, Purified Water USP, and Water for Injection USP
Introduction:
Water, a seemingly simple substance, is fundamentally crucial for life across the universe. Comprising approximately 70% of the human body, it is recommended for an individual to consume about 2-3 liters daily for optimal health (Arend-Jan Meinders et al.). At LacerdaCare, understanding the nuances of water types is not just academic – it's a cornerstone of our commitment to providing unparalleled care. This article delves into the critical distinctions between water types in medical and pharmaceutical contexts, underscoring their significance in healthcare and the Pharma field.
The types of water used in the healthcare industry is quite varied, the way the general public perceive water is different compared to a medical professional. To a layman water will be a beverage to quench thirst, a substance used to wash off dirt and to make something clean or an ingredient in preparing food, diluent for cleaning etc.
The Criticality of Precision:
In healthcare, precision in using the correct water type is not just a best practice; it's a matter of life and death. Utilizing non-sterile water in place of Water for Injection USP, for example, could lead to severe complications like pyrogenic reactions, potentially fatal in vulnerable patients. Similarly, erroneous substitution in laboratory settings, such as using tap water instead of Purified Water USP in analytical tests, might result in misleading outcomes due to impurities, impacting patient diagnoses and treatments.
Potable Water
Description of Potable Water...
The water obtained from the filters used in our homes which undergoes UV and/ or RO treatment is considered purified water or filtered water or drinking water.
How is it prepared?
By using a commercially available water purifier which has an RO, UV etc or a combination of such processes.
Where is it used?
Storage
Can be stored in clean closed containers preferably under UV light for to avoid any contamination.
Precaution
Recommended as drinking water. Should not be used in place of Purified Water as it does not meet the safety standards.
Specifications:-
TDS (Total Dissolved solids): 50 - 150
Arsenic: 10 microgram per litre
Barium: 1300 microgram per litre
Fluoride: 1500 microgram per litre
Boron: 2400 microgram per litre
Selenium: 40 microgram per litre
Uranium: 30 microgram per litre
As per WHO[2]
Purified Water USP
Description of Purified Water USP...
It is prepared by subjecting potable water to processes like deionization, distillation, ion exchange, membrane filtration etc and should conform to standards mentioned in the USP monograph for purified water.
Used in the manufacture of non-parenteral dosage forms like syrups, granulation etc.
Used to conduct analytical tests unless specified.
Used to dilute cleaning agents for surface cleaning in hospitals, clinics and pharmaceuticals.
Should always be stored in perviously clean and dried containers, by first rinsing with a little purified water and an airtight seal.
Not recommended for drinking readily. Should ensure tonicity with body tissues and added mineral before using.
pH: 5.0 - 7.0
Chloride: 0.5 mg/l
Sulfate: 1.0 mg/l
Ammonia: 0.03 mg/l
Calcium: 1.0 mg/l
Carbon dioxide: 5.0 mg/l
Bacterial Endotoxin: NMT 100 CFU/ml
Total Organic Carbon: NMT 500ppb.[3]
Water for Injection USP
Description of Water for Injection USP...
The water obtained when purified water is subjected to further distillation to make it free from bacterial endotoxins hence only WFI can be used in the manufacture and as a vehicle for parenterals.
It is made free from bacterial endotoxins like pyrogens by further distilling purified water in distillation tanks and always kept in constant motion and above 80 degree Celsius until it is used.
Used to manufacture injectable drugs as a vehicle for the Active Ingredients.
When cooled WFI can be considered as distilled water as it has undergone distillation.
Used to generate pure steam for autoclaving equipments ensuring highest possible sterility
To store the bulk of the WFI it is mandatory to keep it above 80 degree celsius, in motion in a closed loop and re-distilled.
For use in reconstituted injectables and where WFI is recommended it has to be stored in single use sealed vials or ampoules that have been terminally sterilized after aseptic filling, and should not contain more than 1000ml of WFI per container to avoid contamination.
Can be used in place of Purified water. Should not be ingested. Should not be used in continuous IV unless tonicity (using 9% NaCl) is maintained with the body tissues, commonly called normal saline.
All other specifications of purified water USP in addition to
Bacterial Endotoxin: NMT 0.25 CFU/ml
Sterility: No growth should occur
Particulate Matter: Should not exceed 3000 particles per 100ml for particle sizes greater than equal to 10 micrometers.[4]