Cleanrooms

Cleanrooms Australia is a specialist cleanroom design and construction company that excels in delivering turnkey cleanrooms.

We oversee the complete cleanroom process to design, construct and install fully integrated cleanroom systems. From handling the design, selecting the construction materials and method, to supervising our experienced in-house tradespeople, we’ll closely manage every stage of your cleanroom project.

This turnkey approach allows us to achieve a quality outcome that is far superior to other cleanroom products on the market.

What is a cleanroom?

A cleanroom is a controlled environment that excludes contaminants such as microbes, particles and vapours.

Cleanrooms come in many different shapes, styles and classes. They are usually used for controlled manufacture or research and development applications, and can be custom designed and built to suit your particular requirements.

Cleanrooms are constructed to a specific set of standards. These standards primarily specify the quantity of particles at a certain size that are allowable to be contained within 1m³.

Cleanrooms commonly control other internal environmental factors such as temperature, humidity, microbial control, conductivity, and lighting and sound levels.

The objective of all cleanrooms is protection

Cleanrooms protect your people, product or environment — and sometimes all three at once.

There are many different standards that govern cleanroom classification, but what you are trying to protect and achieve will dictate the design and specifications of your cleanroom.

For example, some cleanrooms only require a light filtration of air, while other more stringent cleanrooms can require complete laminar flow of highly filtered air.

Why would I need a cleanroom?

From manufacturing food to Ferraris, cleanrooms are seen by nobody and used by everybody.

Most cleanrooms are built for one of three reasons:

1. They are required by law.

2. They are required by a third party (for sub-assemblies) of a larger manufacturing process.

3. They are necessary to minimise failure or recall rates on your product or service.

Cleanrooms are required across a range of industries, including:

• Veterinary medicine
• Pharmaceuticals
• Research and development
• Industrial manufacture
• Food processing
• contract packing
• Surgical implants
• Single dose drug manufacturing
• Manufacturing for international markets
• Fibre optics
• Lithography
• Military manufacture
• Military maintenance
• Spray booth

What cleanroom standards may I need to comply with?

Each cleanroom classification standard has a specific field of use. For example, the ISO 14644 standard (which has been adopted into the Australian standards as AS/NZS 14644 2002) is an international standard that aims to achieve the international standardisation of manufacture.

Other cleanroom standards may apply to manufacturers who want to comply with regulations set out by the Therapeutic Goods Administration (TGA) — Australia’s regulatory authority for therapeutic goods.

Likewise, companies in the agriculture, fisheries and forestry industries may require cleanrooms that comply with the Australian Quarantine and Inspection Service (AQIS) standards.
Some current and historical standards that cleanrooms can be manufactured to are:

• ISO 14644
• Australian code of Good Manufacturing Practice (GMP)
• Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme (PICS)
• Australian Standard (AS) 1386 1989

How do I know that a cleanroom is built to one of these standards?

Most of our clients need to prove that their cleanroom is performing to the required standards before they produce products or services. This is why when we hand over a facility, we provide a NATA traceable certificate that certifies the performance of our products.

What are the different types of cleanrooms?

Hardwall cleanrooms

Hardwall Clenrooms are the most common type of cleanroom. They feature a strong, permanent construction, and usually include multiple rooms. They are highly durable and can be used as a freestanding, self-contained room to effectively control the level of contamination in the air.

Softwall cleanrooms

Softwall Cleanrooms offer increased flexibility and can be installed within a pre-air-conditioned area such as laboratories, offices, or in some instances, warehouses. They help exclude a dirtier environment from a critical process, and our specialist team of designers works to the strictest Australian ISO 14644 and GMP standards.

Mobile and portable cleanrooms

Our Mobile Cleanrooms are manufactured at our Sydney facility and can be transported almost anywhere by truck or helicopter. Mobile cleanrooms can be landed in existing warehouses with minimal logistical overheads. Some of our portable solutions are completely contained within a transportable frame and can be quickly deployed to a remote site at a low cost.

Modular cleanrooms

Modular Cleanrooms take advantage of a pre-existing conditioned space, and give you the option to alter or expand your cleanroom as needed. Modular cleanroom systems are perfect in providing a less robust, non-permanent solution that can be assembled, reconfigured and moved around.

Containment facilities

Containment Facilities use negative pressure to stop dangerous contaminates escaping into non-controlled areas. Just like cleanrooms, containment facilities have different classifications — each with specific requirements and construction techniques.