Mixed Bed Ion Exchanger in Purified Water System : Pharmaguideline -->

Editable Pharmaceutical Documents in MS-Word Format


Mixed Bed Ion Exchanger in Purified Water System

Mixed bed ion exchanger has an important role in the purified water system. Article explains its importance and regeneration of the bed.
Water is a key element for the pharmaceutical and healthcare industries. Pharmaceutical manufacturers are concerned with producing purified water that meets defined standard quality to minimize any risk to patients' health or interfere with the manufacturing process. Water acts as an important ingredient in many formulations and also as a cleaning agent.

This makes the production of highly purified water and pyrogen-free for injection to very critical and should meet the international standards. The most common and accepted method of purification is the use of mixed bed ion exchanger in the purified water systems for pharmaceuticals.

Mix bed system
A mixed bed ion exchanger in water purification uses two ion exchange regenerative systems formed in beads shape. It allows the cation and anions resin beads to mix together to remove impurities to produce high-quality water.

The mixed bed ion exchanger acts as a deionizer and effectively removes the ions present in the water and are capable of contaminating the manufacturing process. 

The mixed bed usually contains a strong acid cation exchange in addition to a strong base anion exchange resin and completely removes the hydrogen and hydroxyl ions from the purified water. De-ionization produces extremely high-quality water with regard to dissolved ions and minerals.

Related: Use of Ion Exchange Resins in Water Purification Systems

Failure to regenerate the resin at an appropriate time may result in the production of harmful salts in the water due to increased concentration. Sometimes the exhausted resin beds may lead to increased levels of dangerous contaminants due to resin's selectivity of specific ions. This adds particulates and resin fines to deionized water.

Water with undesired minerals in pharmaceuticals may cause corrosion in equipment during cleaning. This may lead to interference to health levels recommended for the drug manufacturing process. Contamination will also occur in operations that require water to be used as a solvent in different formulations. Any additional mineral or ingredient into the compounds may pose danger to human health upon administration of the drugs. This is why mixed bed ion exchanger for purified water systems is highly recommended for pharmaceutical processes. 

Related: Sanitization of RO Membranes in Purified Water System

It is very important to note that when water is heated to produce steam during the manufacturing process, any impurity can precipitate and may cause damage. The cations and anions in the water require the use of mixed bed ion exchanger as the resin.

This combined system will result in demineralization and hence pure water. The cation resin is required in the form of hydrogen (H+) and anion resin in the form of hydroxide (OH–). This combination will give you the cation resin generated with an acid and anion resin generated with an alkali.

This result makes the mixed bed ion exchanger as the only perfect alternative for water purification in the pharmaceutical and health industries for the manufacturing process and equipment cleaning. This will ensure good quality products, supplements and drugs that do not pose danger to human health. Pharmaceuticals give products that improve general human health and should not in any way to cause more harm.

Also see: Purified Water System Validation

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of pharmaguideline.com, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
.moc.enilediugamrahp@ofni :liamENeed Help: Ask Question

No comments: Read Comment Policy ▼

Post a Comment

Please don't spam. Comments having links would not be published.

Popular Categories

QA SOPs QC SOPs Micro SOPs HVAC Production SOPs Stores SOPs Checklists Maintenance SOPs HPLC Sterile GLP Validation Protocols Water System GDP Regulatory Maintenance Calibration Warning Letters Education B.Pharmacy
Video Tutorials
Subscribe on Youtube

Submit Guest Posts

Follow Pharmaguideline



Editable Pharmaceutical Documents in MS-Word Format. Ready to use SOPs, Protocols, Master Plans, Manuals and more...




Pharmaceutical Updates

✔ Worldwide Regulatory Updates
✔ Pharmaceutical News Updates
✔ Interview Questions and Answers
✔ All Guidelines in One Place


Recent Posts