What is a clean room? Why do I need a clean room?

A clean room is a controlled environment that is designed to minimize the introduction of contaminants, such as dust, particles, and microorganisms. Clean rooms are used in a variety of industries, including pharmaceutical manufacturing, food processing, and semiconductor fabrication.

The design and construction of a clean room is critical to ensuring its effectiveness. The walls, floors, and ceilings of a clean room must be smooth and impervious to prevent the accumulation of contaminants. The air in a clean room must be filtered to remove particles and microorganisms. The temperature and humidity in a clean room must be controlled to prevent the growth of microorganisms.

The personnel who work in a clean room must also be properly trained and gowned to prevent the introduction of contaminants. They must wear hairnets, face masks, and gloves to protect the clean room environment.

Clean rooms are an important part of ensuring the quality and safety of products that are manufactured in controlled environments. By following the proper design, construction, and operating procedures, clean rooms can help to protect consumers from the harmful effects of contaminants.

Here are some additional details about the requirements for a GMP s with Good Manufacturing Practice clean room:

  • The air in a GMP clean room must be filtered to remove particles of a certain size or smaller. The size of the particles that must be removed depends on the classification of the clean room.
  • The temperature and humidity in a GMP clean room must be controlled to prevent the growth of microorganisms.
  • The personnel who work in a GMP clean room must be properly trained and gowned to prevent the introduction of contaminants.
  • The GMP clean room must be regularly monitored to ensure that it is meeting the required standards.

By following these requirements, GMP clean rooms can help to ensure the quality and safety of products that are manufactured in these controlled environments.

  • Equipment verification: All equipment used in a GMP clean room must be verified to meet the required standards of cleanliness and functionality. This includes equipment such as air filters, air handling units, and clean room garments.
  • Personnel qualification: All personnel who work in a GMP clean room must be qualified to do so. This includes training on GMP procedures and practices, as well as personal hygiene requirements.
  • Process validation: All processes used in a GMP clean room must be validated to ensure that they consistently produce products that meet the required standards of quality and safety. This includes processes such as cleaning, sterilization, and packaging.
  • Workflow: The workflow in a GMP clean room must be designed to minimize the risk of contamination. This includes procedures for personnel movement, equipment use, and product handling.
  • Sanitation and cleanliness: A GMP clean room must be kept clean and sanitary at all times. This includes cleaning and disinfecting surfaces, as well as controlling the levels of dust, humidity, and temperature.
  • Record keeping and documentation: All activities in a GMP clean room must be recorded and documented. This includes records of equipment verification, personnel qualification, process validation, workflow, sanitation, and cleanliness.
  • What type of clean room do I need?

The type of clean room you need will depend on the specific requirements of your manufacturing process. If you are a manufacturer of non-sterile medicinal products, you should define your own clean room/area standards using national and international standards. Usually manufacturers will define an airborne particulate concentration standard class such as ISO 14644-1 ISO 8 (at rest), outline gowning and a pressure cascade regime, defining a “clean corridor” design or a “dirty corridor” design.

If you are a manufacturer of sterile medicinal products, you must follow the EU or PIC/S GMPs, namely Annex 1. These guidelines specify the requirements for clean rooms used in the manufacture of sterile medicinal products. The requirements include the following:

  • The clean room must be designed and constructed to minimize the introduction, generation, and retention of particles.
  • The air in the clean room must be filtered to remove particles.
  • The personnel working in the clean room must wear clean room clothing and follow procedures to minimize the introduction of particles into the clean room.
  • The equipment used in the clean room must be designed and operated to minimize the introduction, generation, and retention of particles.

The specific requirements for clean rooms used in the manufacture of sterile medicinal products are complex and can vary depending on the specific product being manufactured. It is important to consult with a qualified expert to determine the specific requirements for your clean room.

What are particle counters & its impact in clean rooms ?
Particle counters are devices that measure and count small particles in the air or liquid. They are used in a variety of industries, including manufacturing, pharmaceuticals, and food processing.

There are two main types of particle counters: optical and electrical. Optical particle counters use a beam of light to measure the size and concentration of particles. Electrical particle counters use an electric field to measure the size and concentration of particles.

Particle counters are important tools for quality control and environmental monitoring. They can be used to ensure that the air or liquid being processed meets certain standards, and to identify sources of contamination.

The following are the key ingredients of how particle counters work:

  • A light source: This is usually a laser, which produces a beam of light that is very pure and consistent.
  • A lens: This focuses the beam of light into a narrow beam.
  • A particle detector: This detects particles that pass through the beam of light.
  • A data acquisition system: This records the number and size of particles that are detected.

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Particle counters are a valuable tool for measuring and counting small particles. They are used in a variety of industries to ensure quality control and environmental monitoring.

  • They can be used to measure a wide range of particle sizes.
  • They are relatively easy to use and maintain.
  • They are available in a variety of sizes and configurations to meet the needs of different applications.

Optical particle counters are more common than electrical particle counters. They are easier to use and maintain, and they are less expensive. However, optical particle counters can only measure particles that are larger than a certain size. Electrical particle counters can measure particles of all sizes, but they are more complex to use and maintain.

Particle counters are an important tool for measuring and controlling the quality of air and water. They are also used to monitor the environment for pollutants. Particle counters are a valuable tool for a variety of applications.

Here are some additional details about how particle counters work:

  • Optical particle counters:Optical particle counters use a laser beam to measure the size and concentration of particles. The laser beam is passed through a sample of the fluid or gas, and the particles scatter the light. The amount of light scattered is proportional to the size of the particle. The particle counter can then count the number of particles and measure their size.
  • Electrical particle counters:Electrical particle counters use an electric field to measure the size and concentration of particles. The particles are charged by the electric field, and they are then attracted to a collector plate. The number of particles collected on the plate is proportional to the size and concentration of the particles in the sample.

Particle counters are an important tool for measuring and controlling the quality of air and water. They are also used to monitor the environment for pollutants. Particle counters are a valuable tool for a variety of applications like Monitor Fine Particulates for Clean room Manufacturing, Sensitive Production, and HVAC Systems. Airborne particle counters play a crucial role in monitoring, classifying, and diagnosing the source and complexion of contaminants in clean room operations.

  • Some clean room jargons that need to be followed :

Here is some clean room jargon, acronyms, and technical aspects that you can use Air change rate (ACH): The number of times the air in a clean room is replaced with fresh air per hour.

  • Micron (μm): A unit of length equal to one-millionth of a meter.
  • HEPA filter: A high-efficiency particulate air filter that can remove 99.97% of airborne particles 0.3 microns or larger.
  • Dispersed oil particle testing (DOP testing): A test that measures the efficiency of a HEPA filter by counting the number of oil particles that pass through the filter.
  • Airlock: A room or chamber that is used to control the flow of people and materials into and out of a clean room.
  • Clean room classification: A system for classifying clean rooms based on the number of airborne particles per cubic meter.
  • Room recovery rate: The time it takes for a clean room to return to its designed cleanliness level after a contamination event.
  • Particle count: A test that measures the number of airborne particles in a clean room.
  • Clean room certification: A process that verifies that a clean room meets the requirements of a specific standard.

 

This ISO standard includes these clean room classes: ISO 1, ISO 2, ISO 3, ISO 4, ISO 5, ISO 6, ISO 7, ISO 8 and ISO 9. ISO 1 is the “cleanest” class and ISO 9 …

 

ISO 146441-1 clean room particle count standards table  

How is Cleanliness Measured in Clean rooms?

Cleanliness in clean rooms is measured by the concentration of airborne particles. Particles are measured in microns, which is one-millionth of a meter. The human eye cannot see particles smaller than 10 microns. Clean rooms control the environment down to 0.01 and 0.05 micron particles.

The concentration of airborne particles is measured using light scattering airborne particle counters (LSAPC). LSAPCs determine the concentration of airborne particles equal to and greater than the specified sizes. The measurements are taken at designated sampling locations.

The ISO 14644-1 standard classifies cleanrooms based on the concentration of airborne particles. The standard considers threshold particles of 0.1 microns to 5 microns in size. Classification 1 is the cleanest, while classification 9 is defined as room air.

The ISO 14644-1 standard does not consider particle populations outside the given particle size range. For ultrafine or nano-scale particles (smaller than 0.1 microns), a separate standard is used to measure and address air cleanliness. Particles larger than 5 microns are considered macro particles. Requirements here are stipulated by another standard.

ISO standards are reviewed every five years. Clean room manufacturers and operators should stay up-to-date with the latest standards to ensure that their clean rooms meet the required cleanliness levels.

Here are some additional tips for maintaining a clean room:

  • Use clean room clothing and equipment.
  • Follow proper procedures for cleaning and disinfecting the clean room.
  • Minimize the number of people entering the clean room.
  • Control the humidity and temperature in the clean room.
  • Use air filters to remove particles from the air.
  • Monitor the cleanliness of the clean room on a regular basis.

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Here INSTRUKART introduces the Extech VPC 300: A Comprehensive Quality Analyser

The Extech VPC300 is a video particle counter with built-in camera that can measure up to 6 channels of particle sizes (down to 0.3 µm), air temperature, humidity, dew point, and wet bulb. It also has a built-in 320×240-pixel camera that takes videos (3GP) and photo images (JPEG) and records them in internal memory. The VPC300 can store 5000 records (date, time, counts, humidity, temperature, sample volumes, and location label) and 20 minutes of video.

The VPC300 can measure particles in the size range of 0.3 to 10 microns. This size range includes most of the airborne particles that can be harmful to human health. The VPC300 also measures air temperature and relative humidity, which can affect the size and concentration of airborne particles.

It is also a valuable tool for environmental scientists, industrial hygienists, and occupational health professionals.

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