Purified Water System

Pharmaceutical manufacturing process requires Purified Water as per United States Pharmacopea USP23 standard as minium. Major emphasis is on bacteria, pyrogen, TOC in addition to TDS. Purified Water System removes ionic impurities upto ppm level. PW system includes several process steps to achieve such specifications. The plant equipments are manufactured out of materials like SS316L. It is pre-requisite to have sanitisable system.

Storage and Distribution Loop

This becomes an equally important system as PW system. The storage tanks are specially designed with certain RA finish with specially designed sanitary pumps. The distribution loop should have minimum dead legs with orbital welding and zero dead leg POU valves with recirculation loop.

Water for Injection WFI System

Water for Injection is water purified by distillation process to remove dissolved ions, microorganisms and endotoxins. It complies with International Pharmacopeias including USP, EP and JP. Water for Injection is intended for use in the preparation of parental solutions.

Clean Steam Generators (CS)

This is steam produced from treated water, free from volatile additives, such as amines and hydrazines, basically used for sterilizing products, conditioning material or process equipment with which it comes into contact. When the steam condensation complies with the pharmacopoeia parameters for injectable quality water, it is called Pure Steam.

Qualification Documents
DQ Design Qualification
IQ Installation Qualification
OQ Operation Qualification
PQ Performance Qualification