Water plays a vital role in the manufacturing of medicines and ensuring its quality. Pharmaceutical water acts as both a raw material and a processing aid in formulation and cleaning processes. It is one of the major raw materials used in the pharmaceutical industry. However, contamination of water at any stage can negatively impact drug quality and safety. This article explores the importance of ensuring high quality pharmaceutical water in medicine production.
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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