Plant Layout:
Once you have decided on where to locate your pharmaceutical company, the next important thing you need to do is to plan a suitable layout for your pharmaceutical plant. While designing a pharmaceutical plant, you need to understand and follow the basic regulatory requirements for the construction of a pharmaceutical plant.
According to National Agency for Food and Drug Administration and Control (NAFDAC), your proposed layout and design should aim at minimizing the risk of errors and permit effective cleaning and maintenance in other to avoid cross-contamination, build-up of dust or dirt and in general, any adverse effect on the products.
Features of a good pharmaceutical plant layout
A good pharmaceutical plant layout should possess the following characteristics:
There should be room for adjustment and modifications whenever the need arises.
Advantages of a good pharmaceutical plant layout
The advantages of a good pharmaceutical plant layout includes but are not limited to
Conclusion
Planning the layout of a pharmaceutical plant is an important decision as it represents long‐term commitment. It is also a continuous process as there are always chances of making improvements or adjustment to the existing arrangement.
It should be so designed that the functioning of plant would become very efficient by providing optimum relationship among output, floor area and manufacturing process. Although pharmaceutical plant layout differs from plant to plant, the basic principles governing pharmaceutical plant layout are more or less same.
How Neozenith Help you in your Plant Layout:
Introduction
“Room with a defined concentration of airborne particles, designed and used in a way that the number of particles introduced into the room or originating and being deposited in the room is as small as possible, and in which other cleanliness-relevant parameters such as temperature, humidity and pressure can be controlled as required”
CLEANROOMS OVERVIEW
Clean Rooms are used where small particles can adversely impact the manufacturing process and the quality and hygiene of the manufactured product. Clean rooms help in reducing the contamination caused by particles and control the environmental parameters such as temperature, humidity and pressure. The most important component of clean rooms is the HEPA filter, which assists in reducing particles that are 0.3 micron and larger in size.
Air in the enclosed room is passed through the clean room and the HEPA filters. In some cases where rigorous cleanliness is essential, the Ultra-Low Particulate Air (ULPA) filters are used in the cleanrooms process.
It is of utmost importance for the personnel to undergo a training process to control the contamination in the clean room. They should always enter the clean room with a must wear special clothing, which is designed to not expose contamination that are naturally released or generated by skin and body.
ISO Clean Room Classifications
Clean room classifications are on the basis of how clean the air is in the enclosed area. As per the Federal Standard 209 (A to D) of the USA, the number of particles equal to and greater than 0.5 µm is measured in one cubic foot of air, and this is used as a benchmark for ISO cleanroom classification. This is also acceptable in the Federal Standard 209E version, which is used domestically. The latest version of the standard is TC 209 from the International Standards Organization and both of these standards classify clean rooms on the basis of the number of particles found in the area’s air.
Clean Room Classification is based on the number and size of particles permitted per volume of air in an enclosed area. Large numbers like “class 100” or “class 1000” refer to FED_STD-209E, which refers to the number of particles of size 0.5 µm or larger permitted per cubic foot of air.
As per Federal Standards 209E and ISO 14644-1, there is a log-log relationship between particle size and its concentration, which concludes that there is nothing as a 0 particle concentration. The ordinary room air falls under approx. Class 10,00,000 or ISO 9 clean room classification.
Class | Maximum | FED STD 209E | |||||
>=0.1 µm | >=0.2 µm | >=0.3 µm | >=0.5 µm | >=1 µm | >=5 µm | equivalent | |
ISO 1 | 10 | 2 | |||||
ISO 2 | 100 | 24 | 10 | 4 | |||
ISO 3 | 1,000 | 237 | 102 | 35 | 8 | Class 1 | |
ISO 4 | 10,000 | 2,370 | 1,020 | 352 | 83 | Class 10 | |
ISO 5 | 100,000 | 23,700 | 10,200 | 3,520 | 832 | 29 | Class 100 |
ISO 6 | 1,000,000 | 237,000 | 102,000 | 35,200 | 8,320 | 293 | Class 1,000 |
ISO 7 | 352,000 | 83,200 | 2,930 | Class 10,000 | |||
ISO 8 | 3,520,000 | 832,000 | 29,300 | Class 100,000 | |||
ISO 9 | 35,200,000 | 8,320,000 | 293,000 | Room Air | |||
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