International Islamic University Chittagong

Department of Pharmacy

Students ID: P-161209

Course Code: Pharm-4801

Course Title: Pharmaceutical Technology-III

Session: Autumn-2019

Assignment on: Clean room is the integral part of

cGMP
Clean room:

A clean room is a room with different environmental control of particle and microbial

contamination, constituted and used in such a way as to reduce the introduction, generation and

retention of contaminants within the area.

cGMP:

Current good manufacturing practices (cGMP) are defined as systems to assure proper design,

monitoring, and control over manufacturing processes and facilities in pharma industries. These

systems are designed to help organizations to assure that drug products contain the correct

identity, strength, purity, and quality.

There are several tests performed in clean room. These tests are

performed regularly. These tests include:

 Airflow velocity, volume and uniformity tests.

 Hepa filter installation leak tests

 Airborne particle count test

 Room pressurization test

 Airflow parallelism test

 Temperature/RH test

Some of the features of clean room include following :

 Exclusion of the environment external to the suite of cleanrooms

  Removal or dilution of arising from the manufacturing process and personnel

working in the area

 Containment of hazards arising from the product

 Control of product-to-product cross-contamination

Clean room helps to ensure products quality by reducing contamination of process and materials

and is accomplished by reducing the sources of contamination and thus accomplish the feature of

cGMP by assuring product quality, safety, strength.

So from the above discussion we can say that Clean room is the integral part of cGMP.