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Cleanrooms Assure Quality As Per cGMP Norms

November 08, 2019



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The manufacturing processes in pharmaceutical sector should be well controlled to prevent contamination from raw materials, finished products and workforce as well as accommodating services, such as processing unit and equipment. The key purpose of a cleanroom is to provide the quality assurance of product according to current good manufacturing practices. The cleanroom facility should prevent contamination of the product and should be equipped with sophisticated monitoring devices.


The need for cleanrooms


The cleanroom is a modern phenomenon. The dirt-free conditions provided by the cleanrooms are essential for manufacturing electronic components and dirt and bacteria-free conditions are essential for manufacture of drugs and other medicinal products. Without clean conditions, products get contaminated and either malfunction or become hazardous to people. For these reasons cleanrooms are widely used in pharmaceutical industries and also in electronic industries.


Cleanrooms are also now used for the manufacturer of items used in computers, cars, aeroplanes, spacecraft televisions, disc players and many other electronic and mechanical devices, besides the production of medicines, medical devices and convenience foods.


In recent years there has been a considerable increase in the number of cleanrooms. This rapid increase in the use of cleanrooms has created a demand for good quality information about cleanrooms that is free from the intensive publicity of sales and marketing jargon. Information is also required to teach production personnel about their working environment, and how to conduct themselves within the cleanroom to minimize contamination.


In a cleanroom, the introduction, generation and retention of particles are minimized. This is achieved, firstly, by supplying it with exceptionally large qualities of air that has been filtered with high efficiency filters.


This air is used to:


Dilute and remove the particles and bacteria dispersed from personnel and machinery with the room;

Pressurize the room and

Ensure that no dirty air flows into the cleanroom.

Secondary, a cleanroom is built with materials that do not generate particles and can be easily cleaned. Finally, cleanroom personnel use clothing that envelope them and minimizes their dispersion of particles and micro-organisms. According to the process, cleanrooms can also control the temperature, humidity, sound, lighting and vibration.


The primary purpose of a cleanroom is to ensure production of a product with high quality. The cleanrooms range from very small chambers, called micro-environments, to large scale rooms, called ballrooms. They are used in pharmaceutical industry as well as in other industries such as biotechnology, nanotechnology, microelectronics etc.


Production process need to be controlled effectively:


Cleanrooms are designed to control and limit temperature, humidity, air pressure and particles. As of late, cleanrooms have become crucial as pharmaceutical products should be manufactured under the requirements of good manufacturing practices. A cleanroom can be termed as a room in which the concentration of air borne particles is well regulated and is built and used in a manner to minimize the introduction, generation, and retention of particles inside the room and in which other relevant parameters, viz. temperature, humidity, and pressure are controlled as per requirement. The basic function of a cleanroom is to protect the manufactured product from contamination. In the pharmaceutical production, the economical survival of the manufacturing company depends on the safety of the finished product. So, it is necessary to know the potential sources of contamination, which could include the working environment itself.


Bacteria


Bacteria – in microbiology is a single-celled or non-cellular spherical or spiral or rod-shaped organism lacking chlorophyll that reproduce by fission. Important as pathogens and for biochemical properties, bacteria are the most significant contaminant in a pharmaceutical cleanroom. Normally, bacteria enters a clean room through the equipment and materials which are taken in and taken out from the cleanroom.


The workforce is also responsible in spreading the contamination in a cleanroom. So, it is important to know the number of workforce employed in a cleanroom. Health, hygiene and clothing of the workforce are very significant factors to maintain the desired quality of specifications in a clean room and airborne contamination is very common source, which occur during transfer of materials from cleanroom to environment and vice-versa. Special attention is required to prevent airborne contamination. Airborne contamination from outside is a usual problem for cleanroom. To reduce the holes in cleanroom, construction should be minimized. It is possible to reduce contamination transfer to prevent an unacceptable flow of air from a lower area to a higher area.


Contamination


Contamination is a process that causes materials, surfaces or environment to be soiled or adulterated with contaminating substances. There are two broad categories of surface contaminants: film type and particulates. These contaminants can produce a killer defect in a miniature circuit. Film contaminants on only 10 nanometres can drastically reduce coating adhesion on a wafer or chip. It is widely accepted that particles of 0.5 microns or larger are the target. The generated contaminants must be continually removed from the air. There are several sources of contamination such as process  equipment, personnel and surfaces. An important source of particulate contamination is process equipment.


Cleanroom design


Cleanrooms are designed to maintain positive pressure, preventing unclean (Contaminated) air from flowing inside and less-clean air from flowing into clean areas. The idea is to ensure that filtered air always flows from cleanest to less-clean spaces. In a multi-chambered cleanroom, for instance, the cleanest room is kept at the high pressure.


Pressure levels are set so that the cleanest air flows into space with less clean air. Thus, multiple pressure levels may need to be maintained. A differential air pressure of 0.03 to 0.05 inches water gauge is recommended between spaces. In order to ensure that pressure differentials remain constant when doors are opened, or other events occur, control systems must be in place.


Conclusion


The production processes in pharmaceutical industries required to be controlled effectively to prevent various types of contaminations from people, raw materials, finished products as well as accommodating services, process plant and equipment. The requirements that are available are involved in the overall design and a complex construction process and cleanrooms guarantee a high standard and quality of product. The successful cleanroom operation can be achieved by developing a team including all relevant personnel from production, quality, logistics, maintenance and engineering departments at the early stage of a design to develop the initial user requirement specification. The user requirement specification gives criteria pertaining to process, equipment, operations, capacities and the environment for the new cleanroom. Various international standards of designing cleanrooms are available and the cleanrooms should be designed according to process requirements and standards.