February 28, 2024

Cleanroom Standards and the Importance of Using a Trusted and Bespoke Manufacturer to Design and Construct Your Cleanroom.


A cleanroom is a controlled environment that provides a meticulous contaminant-free atmosphere that encompasses a specific manufacturing process or laboratory.

They can be used in a variety of industries where small particles can detrimentally impact on the processes being undertaken within the room.

Many industries benefit from the control of airborne contamination including aerospace, microelectronics, pharmaceuticals, medical devices, food and healthcare.

Having an effective and safe cleanroom is vital. Controlling the quality of the air within cleanrooms is crucial for the health and safety of the employees working inside them, and for the quality of the products being manufactured within.

Safety is especially important when it comes to cleanroom environments. No one wants to risk either their employees or products being hurt from an unsafe or contaminated environment. This is why all cleanrooms must follow strict standards in Australia and New Zealand to ensure that no one’s health and safety is compromised, and the job is completed without any problems.

Every cleanroom classification standard has a specific field of use, depending on what the cleanroom is being used for. ISO 14644 is an international standard that aims to achieve an international standardization of cleanrooms. It has also been adopted into Australian and New Zealand Standards under Cleanrooms and associated controlled environments (AS/NZS 14644). Other cleanroom standards may also apply to some manufactures, who will want to comply with the regulations set out by the Therapeutic Goods Administration (TGA), depending on what they are creating within their cleanrooms.

Under Australia and New Zealand Standards, the requirements are centred around the concentration of airborne particles and keeping certain particles at the right levels, to ensure that whatever is inside the cleanroom is safe for the product and the employees.

It is of the utmost importance that every cleanroom meets the standards specific to them as it is a huge health and safety risk if they aren’t followed. The best way to ensure that your cleanroom meets the standards specific to your business if is you use a trusted bespoke manufacturer to design and construct your cleanroom.

When you choose to have a cleanroom that is made specifically for your certain type of business, it is much easier to ensure that the standards are being met, rather than just buying a market model and tweaking it to meet your industry.

When you use a bespoke engineering company, they will be able to provide you with the unique ability to have a cleanroom designed and programmed for your individual needs and the ability to automate and integrate it with security and industrial supervisory tools.

They will design and engineer a custom cleanroom that will not only meet but exceed the unique and strict standards applicable to your industry.

Many factors besides the airborne particulate cleanliness must be considered when designing a cleanroom. Specification, operation and control of cleanrooms, must also be taken into consideration, as they are covered in detail in International standards that need to meet.

This is a lot to take into consideration, so it is much easier to just leave it to the experts. Some bespoke engineering companies such as Australian companies like DRYSYS will also provide consultancy and training services to your employees on operating and maintaining your bespoke cleanroom. Companies such as DRYSYS will also uniquely design your cleanroom to fit into good manufacturing practice (GMP) requirements and individually create your product to fit the specific product flow, personnel flow, cleaning protocols, process heat load and the exhaust temperature and relative humidity requirements of your plant. That way, nothing will go wrong, and the health and safety of your employees and your products will always be top of mind.

While it is easier to leave meeting cleanroom standards up to the professionals, it is also extremely important to leave it to the best in the industry. The health and safety of anyone, especially those who enter your cleanroom, should be first and foremost the most important part of your business. Complying with the correct international and national standards and training your employees on how to operate and maintain the cleanroom, is the best way to do this. Having a bespoke cleanroom created for you by a trusted manufacturer is the perfect step in the right direction, and once this is all sorted, you can get back to producing outcomes for your business, in the safest and most productive way possible.