The importance of Pharmaceutical Water
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| Pharmaceutical Water |
Types of Water Used in Pharmaceutical Industry
Water used in Pharmaceutical
Water is broadly classified into three types depending
on its intended use:
Purified Water
Purified water, also known as water for injection (WFI), is used directly in
drug formulations and parenteral products where water comes in direct contact
with the patient. It is produced through processes like distillation, reverse
osmosis, etc. to remove impurities. Purified water complies with stringent
quality standards to ensure it does not harm patients.
Highly Purified Water
Highly purified water is used in early drug manufacturing stages where small
impurities can significantly impact drug quality. It undergoes additional
treatment processes like ion exchange, electrodeionization, etc. to further
lower impurity levels below those required for purified water.
Water for Non-Parenteral Use
This type of water has the least stringent quality requirements as it is not
intended for direct patient use. It is used in processes like equipment washing
where indirect contact with drugs is involved. However, it still needs to be
microbiologically safe to prevent contamination.
Importance of Quality in Pharmaceutical Water
Ensuring the quality of water used at each stage of drug production is crucial
to maintaining overall medicine quality. Some key reasons behind this are:
Safety for Patients
Any chemical or microbial contamination in purified water can directly enter
the patient's body via injectable drugs. This poses health risks. Rigorous
water purification helps deliver safer medicines.
Reliability of Test Results
Impure water can interfere with analytical test methods, yielding inaccurate
results about drug quality attributes. High quality test water is important for
reliable analysis.
Manufacturing Consistency
Inconsistent water properties like pH, dissolved solids content can affect drug
synthesis, processing equipment and product attributes. Tight control over
water quality delivers consistent manufacturing outputs.
Compliance with Stringent Norms
Pharmacopoeial regulations define limits for various water quality parameters.
Meeting these is necessary for production approval and international drug
trade.
Effects of Impure Water on Quality
Contamination of any kind in pharmaceutical water used can negatively impact
drug manufacturing and quality in the following ways:
Microbial Growth
The presence of microbes in water supplies can lead to microbial contamination
of drugs during production or storage. This poses serious safety issues.
Change in Drug Properties
Even trace chemical impurities in water can react with active drug substances
altering their properties, stability and effectiveness.
Process inefficiency
Scale formation or other reactions caused by impure water affect heat transfer
and mass transfer efficiency of manufacturing equipment.
Failed Analytical Testing
Impurities interfering with quality control tests can wrongly indicate
manufacturing issues or result in batch rejections.
Regulatory Non-compliance
Use of substandard water may fail to meet pharmacopeial requirements, inviting
regulatory actions like production shutdowns.
Pharmaceutical water acts as both a raw material and an aid in drug
manufacturing processes. Ensuring the purity, consistency and quality control
of water used at every stage as per regulatory requirements is important to
deliver medicines that are effective and safe for patients. Water purification
technologies play a vital role in maintaining the quality standards expected in
the pharmaceutical industry.
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