Importance of computer system validation (CSV) in Pharmaceutical Industry

In the previous article we got the introduction of Computer system validation, along with the approach objective and requirement. Furthermore we will see the importance of Computer System Validation (CSV) in Pharmaceutical Industry.  Figure-01: Computer system and Validation Why computer system validation (CSV) is important? Computer system validation (CSV) is a compliance activity, documented evidence … Read more

Computer system validation (CSV) in Pharmaceutical Industry !! Introduction

Computerized systems used in the various stages in pharmaceutical Industry. In the modern era Automation / computerization is the become trend or we can say necessity to achieve accuracy / precision in the various tasks. In pharmaceutical Industry computerized systems are being used at various stages of Drug substance / Drug Product manufacturing including Research and Development; Production, clinical … Read more

Ultraviolet (UV) Filtration-Pharmaceutical Purified water system component

In General, Pharmaceutical Purified water system is system made-up with the composition of various sanitization and filtration system. We had information about those systems in previous articles as a part of series of Pharmaceutical Purified Water Generation system for Drug substance. In continuation here we will a brief information on one of the major and important component of Pharmaceutical Purified water … Read more

ELECTRO DEIONIZATION UNIT (EDI) – Pharmaceutical Purified water system

In the series of articles on Pharmaceutical Purified water system for manufacturing of Drug substance / Drug products, previously we had information on other sections/part of the Purified water generation system i.e. Gramicid, Sand Filtration, Water Softner, Micro Filtration and Reverse Osmosis. Another one of the important component of purified water system i.e. ELECTRO DEIONIZATION … Read more

What is Reverse Osmosis in Pharmaceutical Purified water system?

Reverse Osmosis;  In continuation to series of articles on Pharmaceutical Purified Water system, here we will discuss and have basic knowledge on one of the important Component of Pharmaceutical Purified Water generation system for manufacturing of Drug substance and drug products. Reverse Osmosis (RO) is one of the efficient system / component for the generation of … Read more

What is Dosing? in Pharmaceutical Purified water system

 DOSING SYSTEM In Pharmaceutical Process Water Generation system, Dosing is the process of addition of the external chemical components to the water as a part of the process water treatment process. This is required to achieve the aim; to have purified water. There are three types of dosing system required After Micro filtration and Before … Read more

What is Filtration? Pharmaceutical Purified Water System components

A Component of Pharmaceutical Purified Water system for manufacturing of Drug substance and drug products. This Article is summarized with the Details of various FAQ’s on Filtration like; ❓ What is Filtration? ❓ What is Micro-filtration? ❓ What is Ultra-filtration? What is Filtration? After the water softening process, water purification process follows the filtration process, there are … Read more

Water softener: Pharmaceutical Purified Water System components

A Component of Pharmaceutical Purified Water system for manufacturing of Drug substance and drug products. Pharmaceutical Water Some FAQ’s are tried to answered under this Article like; ❓ What is water softening? ❓ Why Water softening is required? ❓ What principle works behind water softener? ❓ What is used as Ion exchanger in water softener? ❓ What are the components of … Read more

Multi Grade Filter (MGF) – Pharmaceutical Purified Water system components

MULTI GRADE FILTER (MGF) A Component of Pharmaceutical Purified Water system for manufacturing of Drug substance and drug products. What is Multi Grade Filter (MGF)? This is Known as Sand Filtration. Multi Grade Filter consists of vertical or horizontal pressure sand filters that contain multiple layers of coarse and fine sand (pebbles and gravels) in a fixed proportion. Figure: … Read more

Gramicid – Pharmaceutical Purified Water system components

GRAMICID A Component of Pharmaceutical Purified Water system for manufacturing of Drug substance and drug products. What is Gramicid? GRAMICID is a multi-component complex formulation of concentrated Hydrogen Peroxide (48 %) and Silver (500 ppm) in cationic form.  Figure: 01 Gramicid Composition What is Gramicid Dosing in water purification process? GRAMICID dosing is required in the water purification process to … Read more