Cleanrooms

Cleanrooms Australia is a specialist clean room design and construction company that excels in delivering turnkey Cleanrooms.

At Cleanrooms Australia we believe that by controlling the complete cleanroom installation we can supply a fully integrated system that works superbly in every aspect. By controlling the design, construction materials, the construction method and supervising the tradespeople we believe that we can deliver a far superior product to the marketplace.

 

What is a cleanroom?

A cleanroom is a controlled environment, and is usually required to exclude contaminants including microbes, particles and vapours.

Cleanrooms are constructed to a specific set of standards.

Clean rooms are usually used for either controlled manufacture or research and development.

The standards specifically control many aspects of a cleanroom but primarily the standards specifies the quantity of particles at a certain size that are allowable to be contained within 1 m³, other items that are commonly controlled are temperature, humidity, microbial control, conductivity, lighting levels, sound levels and many others.

Cleanrooms come in many different shapes styles and classes.

What you are trying to do will decide the type and class of cleanroom you require.

The objective of all clean rooms is protection.

To:
Protect the people
Protect the product
Protect the environment.

And sometimes all three at once.

What you’re trying to achieve and protect, will dictate the type of cleanroom you’re going to require.

Due to the many different standards and the different classes of clean rooms within those standards, there are many different methods of keeping a cleanroom within specification.

Some cleanrooms only require a light filtration of air whilst other more stringent cleanrooms can require complete laminar flow of highly filtered air.

 

Why would I need a cleanroom?

Most clean rooms are built for one of 3 reasons:

  • They are required by law
  • required by a third party ( for sub-assemblies) of a larger manufacturing process
  • necessary to minimize failure rate or recall rate on the product or service

Cleanrooms are required across a range of industries from

  • 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

So from “Food” to “Ferrari’s”, Cleanrooms are seen by nobody and used by everybody.

 

What cleanroom standards may I need to comply with?

Some current and historical standards that clean rooms 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

• USA FED 209E

Each Standard has had its field of use such as
The ISO 14644 standard has been adopted into the Australian Standards as AS/NZS 14644
2002 This is an international standard that lends itself to the international standardisation
of Manufacture as it does not address microbial controls.

OR

The Therapeutic Goods Administration TGA, Australia’s regulatory authority for therapeutic goods.

Department of Agriculture, Fisheries and Forestry (DAFF)
Whose regulatory body is the Australian Quarantine and Inspection Service (AQIS)

Office of the Gene Technology Regulator OGTR

Outside of Australia there have been many further standards some include
American, Asian and European to name a few.

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How do I know that a cleanrooms is built to one of the standards?

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

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