#Pharmawater
#RohitMane
#ScientitRacademy
1. Why water is required in pharmaceutical companies
Key ingredient used in many pharmaceutical and life sciences operations.
Used as a raw material, ingredient, and solvent in the processing, formulation, and manufacture of pharmaceutical products, active pharmaceutical ingredients (APIs) and intermediates.
Should Control of the quality of water throughout the different processes.
Validation of the water production process by testing's.
Total organic compounds (TOC) testing.
Bio burden testing
MPN testing
2. Types of pharmaceutical water
Potable Water
Purified water
Water for injection
Bacteriostatic water for injection
Sterile water for injection
Water for hemodialysis
Sterile water for irrigation
Sterile water for inhalation
Sterile water for analytical purpose
DRINKING WATER
Standard specified by the Bureau of the Indian standard of WHO or US potable water standard 40 CFR 141 or such other standard.
Indian Pharamcopoeia: 500 CFU/ml limit for the total aerobic microbial count for drinking potable water.
Purposes:
For use as a drinking water
Preparation of external use products
Washing and extraction of crude drug
PURIFIED WATER
Water that is projected for human utilization and maybe preserved in bottles and other containers with no added ingredients.
Distillation, Ion exchange or by any other appropriate methods.
Purified water is used as a recipient in the production of nonparenteral preparation and another purpose, such as cleaning of certain equipment and nonparenteral product.
The limit for the microbial population for purified water is 100 CFU\ml.
Difference between purified water and potable water:
Pure water:
Pure water contains no minerals or side chemicals. It is pure H₂O and only contains Hydrogen and Oxygen.
Purified by capacitive deionization, carbon filtering, reverse osmosis, micro-filtration, ultra-filtration, ultraviolet oxidation, etc.
Potable water:
Fit for consumption by human beings and other animals. It is also called drinking water. it is safe for drinking and for food preparation,
WATER FOR INJECTION
Used in the production of parenteral and other preparation where product endotoxin content must be controlled ther purposes such as cling of context part of the equipment when water is used as a vehicle (water for injection in bulk) and for dissolving or diluting substances and in preparation for injections.
The pH of water for injection is 5.0, it may ranges from 5.0 to 7.0.
Preparation Technique of water for injection
Water for injection is prepared by Distillation of potable water or purified water, Reverse osmosis or Membrane process
Storage of Water of injection (WFI):
Difference between purified water and WFI?
Water for injection is highly purified as is condensed and kept it at 80-90 degrees Celcius to maintain its properties and stored in a single dose for Iv administration purpose after the addition of the required amount of solute, while purified water is kept at room temperature.
STERILE WATER FOR INJECTION
It is sterilized within 12 hours of collection and distributed in sterile.
It should be packed only in a single dose container of not larger than a 1-liter size.
Standards given in the monograph of official books or pharmacpoeias.
Microbial limit is not more than 10 CFU per 100 ml.
The total organic carbon (TOC) as per IP is not more than 0.5 mg/ liter. whereas the same limit of TOC is there for this water (500 PPB) in USP and BP.
Preparation technique for SWFI:
By distillation of water for injection.
Use of sterile water of injection:
It is intended mainly for use as a solvent for parenteral preparation such as powder for injection, that is distributed dry because of the limited solubility of their solution.
Water for hemodialysis
It is used as a diluent for hemodialysis concentrate solution.
It is produced from EPA (regulatory agency for regulating drinking water to protect public health)purified water, again treated to prevents the microbiological and chemical attack.
This water is not intended for injection. store in an unreactive container and also avoided from antimicrobial.
Sterile Water for irrigation
It is water for injection that is packaged and sterilized in single-dose containers that in size are larger than 1 liter and allow quick delivery of contents not mandatory to meet the requirements for small-volume injections.
It used for applications that don’t have particulate specifications or wherever pure water or water for injection is indicated.
however, access to the valid water system is absent or larger quantities for sterile water for injection is required.
16 авг 2020
