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ISO Class 7 Cleanrooms Is Right For Manufacturing Requirements

  • 2024-02-02
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There are many factors to consider in your decision – ranging from cost, room setup (with size design) and what exactly you are manufacturing.  However the starting point is to look at the legal, regulatory, manufacturing and marketing requirements for your industry.

ISO Class 7 Cleanrooms Is Right For Pharma and Medical device industry Manufacturing Requirements

The Pharma and Medical device industry for example have specific guidelines when it comes to selecting a Cleanroom.

Another factor to take into consideration is the Cleanroom assembly. An ideal Cleanroom setup should not just be about the injection moulding capabilities like 2k moulding but also (and importantly) – can it be used to assemble parts? This may depend on the Cleanroom provider – the size of their facilities and their capabilities. Typically many companies choose a Cleanroom according to the specifications required but also the assembly capabilities within the room. For example, if you are considering a tooling transfer, a the right cleanroom could be an important factor.

Let’s take a look at one of the most popular and effective Cleanroom types that cover’s many different industries and the one we offer here at Kwang Cleanroom – the ISO class 7 Cleanrooms.

What is an ISO Class 7 Cleanroom?

An ISO Class 7 cleanroom is a type of cleanroom that is meticulously designed to prevent  contamination from happening inside the facility. Typically a Class 7 Certified Cleanroom can be used for injection moulding and final assembly of critical parts for the medical device or electronics industries.

Why use ISO 7 Cleanrooms?

The ISO 7 Cleanrooms facilitates the needs of many different types of clients manufacturing requirements as it maintains extremely low levels of particulate matter such as dust and airborne organisms – quantified by 10,000 particles per cubic meter. The Class 7 environment is tested to ISO 14644-1 and the HEPA (High Efficiency Penetration Air) filtration rate is over 99% efficient.

Kwang Cleanroom is certified to ISO 13485- Medical Devices

An Industry Example – Medical Device Cleanrooms

Invasive procedures involve contact between a medical device or surgical instrument and a patient’s sterile tissue or mucous membranes. Therefore, for safety (and legal) issues – absolute precision and effectiveness is a non-negotiable when it comes to selecting a Cleanroom for medical device manufacturing.

What’s the Best Cleanroom for Medical devices?

Generally speaking medical device manufacturing is conducted in an ISO 5 – 8 Cleanroom (Class 100 – 100,000) & Medical device packaging is conducted in an ISO Class 7- 8 Cleanroom. (It is for this reason that the ISO 7 Cleanroom is a reliable and versatile choice when it comes to medical devices).

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