Pharmaceutical Water Project and Service

Water system compliant with USP and EP standards for pharmaceutical manufacturing.

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FAQ

Purified Water is used in manufacturing of oral liquid dosage, oral solid dosage, creams, ointments and etc.
Water for Injection (WFI) is used in manufacturing of injectable medications, antibiotics, hormones, vaccines, haemodialysis / peritoneal dialysis, ophthalmic solutions and other product that must be sterile.

U.S. Pharmacopeia (USP) and European Pharmacopoeia (EP) standard are the most commonly referenced standards for Purified Water and WFI.
Based on USP standard for Purified water, electrical conductivity of purified water must be ≤ 1.3 µS/cm at 25°C; Total Organic Carbon (TOC) content in purified water must be ≤ 500 ppb (parts per billion); microbial count must be ≤ 100 colony-forming units (CFU) per milliliter (mL) of water.
Based on USP standard for WFI, electrical conductivity of WFI must be ≤ 1.3 µS/cm at 25°C; Total Organic Carbon (TOC) content in WFI must be ≤ 500 ppb (parts per billion); microbial count <10 CFU/100mL; Bacterial Endotoxins ≤0.25 EU/mL.

Based on Malaysia’s city water as a source of water, following are some of the recommended filtration systems:

Sediment filter of Sand/Multimedia Filter (To remove suspended solid or particles).
Carbon Filter (To remove chlorine and protect softener resin/ RO membrane / EDI).
Sodium Bisulphite Dosing (To remove chlorine and protect softener resin/ RO membrane / EDI).
Softener (To remove hardness in water).
Caustic Dosing (To neutralize CO₂ which improves the performance and efficiency of RO and EDI).
Ultrafiltration (To remove bacteria, viruses, suspended solids, colloids, and larger molecules).
Single or Double Pass Reverse Osmosis (To reduce ion content in water).
Electro Deionization Module (To further reduce ion content in water).
UV Sterilizer (To kill or inactivate harmful microorganisms, such as bacteria, viruses, and fungi).
Other filtration methods that are deemed necessary by the system designer.

Generally, WFI is produced through distillation of Purified Water / RO water / water source recommended by system designer.

US FDA 21, CFR Part 11 compliance means the electronic records and electronic signatures are trustworthy and reliable.
Electronic Records of the system must be accurately captured, stored securely, and are readily retrievable.
Electronic Signatures must link the signer to the records and the specific actions performed.
Audit Trails must be implemented to track every action or changes made.
Data integrity must be maintained to prevent unauthorized access, data loss or intentional modification.