Some products, like medicines and many food products, need to be hygienically packed under specific protocols and environmental conditions. These products are usually highly sensitive, meaning that the temperature, humidity, and air particulates in a space must be carefully controlled to maintain the product’s integrity. This is where cleanroom contract packaging comes in.
During a cleanroom packaging process, packing personnel wear special PPE, like protective suits, goggles, rubber gloves, and sometimes even pressurised hazmat suits and breathing apparatus. A cleanroom may only be accessible through airlock doors, and the proper pressure and temperature must be maintained at all times in order to safeguard against airborne contaminants.
These parameters are continuously monitored by AI systems that automatically adjust the temperature, humidity, and pressure, based on the predefined specifications.
In this post:
What is Cleanroom Manufacturing?
Cleanroom manufacturing is the process of handling sensitive products in an environment that’s free of airborne contaminants. This type of manufacturing follows specific standards based on the required cleanliness level for the manufacture of a specific product. As the name suggests, it involves the use of a cleanroom, wherein ambient outdoor air pollutants like dust, microorganisms, and aerosol particles are filtered out to make the manufacturing environment as clean as possible.
Some products, like computer microchips, require cleanrooms in the initial stages of their production. For example, the microprinting of circuits and assembling of small electronic components, like integrated circuits, need an environment that’s free from any type of particulates because these could ruin the precision of the process.
7 Benefits of Cleanroom Contract Packaging
Unfortunately, not every company has a cleanroom facility in which to package sensitive products. This is where cleanroom contract packaging enters the scene. A manufacturing company can outsource the packaging of their products to a contracting company that specialises in cleanroom packaging, and has the facilities they need to eliminate the risk of product contamination.
A dependable and credible contract packing company can provide you with the following benefits of cleanroom contract packaging:
- Clean packaging environment: Many products, such as electronic components, are sensitive to dust and moisture, and require a clean environment during the manufacturing and packaging processes. Cleanroom packaging facilities dramatically reduce the amount of particulate matter in the air. On average, the outdoor ambient air in urban areas has 35 million particles per cubic metre, ranging from the size of a virus (100 nm) to the diameter of a human hair (100 μm). By comparison, cleanrooms have only twelve particles per cubic metre, and these are also much smaller in size
- Convenience: Cleanroom contract packaging arrangements can be hugely beneficial for a manufacturing company that doesn’t have the facility or capacity to do it themselves. By outsourcing to a packing company, the manufacturer also gets more time to focus on research and development, and improve the quality of their products
- Cost-effectiveness: With cleanroom contract packaging, the manufacturer avoids spending large amounts of money and other resources on building cleanroom facilities. Costs are also significantly reduced when it comes to other overhead expenses, such as power consumption. This is an important benefit because cleanrooms require positive air pressure, a complex air conditioning system, and humidity control, which all lead to high energy consumption and expensive bills!
- Controlled environment: Aside from air cleanliness, other factors in a cleanroom must be carefully controlled and monitored. These include the direction and speed of airflow, air pressure, temperature, and humidity level. A contract packaging company that specialises in cleanroom facilities has the expertise to precisely control the various internal environmental conditions of a cleanroom, giving the manufacturer peace of mind that 100% quality is being maintained
- Product purity: Many medicines and other pharmaceutical products require a very high level of purity. This is possible to maintain in cleanrooms because of the very low level of particulate matter in the air – as we mentioned earlier, cleanrooms can have as low as twelve particles per cubic metre
- Delicate handling: If you’ve chosen the right contract packaging company for your cleanroom needs, you can be assured of the delicate handling of your products. The personnel are usually specialised and well trained in handling delicate or sensitive products. They will also be equipped with the proper outfit for the job, as well as the right equipment, and will follow stringent protocols
- Production efficiency: Being able to focus on R&D and product manufacturing, rather than derailing operations to build cleanroom facilities, will help improve the efficiency of your company. Instead of having to undergo cleanroom training, or worry about the packaging process, your personnel will have the time to dedicate themselves to the actual mass production of your products
Different Types of Cleanrooms
Cleanrooms are classified based on ISO standards related to the amount of air particulates that a room can filter out. More precisely, this is the amount of particulates left with corresponding sizes. See the table below for more information:
What is an ISO Class 5 Cleanroom?
A cleanroom under this classification must not have more than 3,520 particulates, measuring less than or equal to 0.5 microns, per cubic metre of air. It must also have 250-300 HEPA filtered air changes per hour.
What is an ISO Class 7 Cleanroom?
This is a common classification of cleanroom. A cleanroom classified under this category must not have more than 35,200 particulates, measuring less than or equal to 0.5 microns, per cubic metre.
What Are the Categories of Particulate Sizes?
To properly understand the classifications of cleanrooms, it’s necessary to understand the categories of particulates in the air. These particulates are mostly solid organic or inorganic matter, like pollen grains, viruses, plant sheddings, minerals, and soil particles. Liquid may also be present, including water vapour and acidic mist.
Particulate matter suspended in the air can be better understood based on the particle sizes. The particulate size is the basis for classifying cleanrooms. They can be classified into the following particulate size categories:
- Coarse particles (PM10): These particles are the largest in size, ranging from 2.5 to 10 μm
- Fine particles (PM2.5): These particles can have negative effects on our health. They include smoke and haze particles, and are at least 2.5 μm or smaller
- Ultrafine particles (PM1): These particles are smaller than 100 nm in size. They can easily pass through the lung tissue and directly into the bloodstream
To have a better understanding of the relative sizes of air particle classifications and how they compare to the human hair, refer to the illustration below:
How Cleanrooms Remain Clean
The cleanliness of cleanroom environments is maintained through high-efficiency particulate air (HEPA) filters. These filters, along with ionizing grids, remove airborne particles through the exhaust of the HVAC system.
Generally, positive pressure is maintained to prevent outside particulates from getting in. The laminar flow of the air is also maintained through precision and directional air ducts. However, when it comes to biomedical laboratories that handle infectious specimens, negative pressure is necessary.
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