CONTINUOUS CLEANROOM MONITORING

Today, businesses in the medical device sector seek to improve their production process by utilizing automation as much as possible. With the development of laser marking technology, medical device manufacturers are able to mark components in a fraction of the time it used to take them and it offers them greater levels of accuracy. For medical device companies of all sizes, it is important to comply with stringent international and national standards for the production of medical devices – and this includes the use of cleanrooms for implementing processes that must be free of environmental contaminants.

ISO 7 Cleanroom Capabilities

ISO 7 cleanrooms are an internationally accepted standard required in the manufacture of medical devices. The cleanroom helps to ensure that the manufacturing process is free from dust particles or any biological contaminants that could potentially interfere with the production process. Presently, Laser Dynamics USA takes cleanroom requirements seriously by providing the highest level of contamination control.

At Laser Dynamics USA, we operate an ISO 7 Class 10,000 cleanroom for our medical device marking services. This cleanroom is designed to provide an environment that ensures no more than 10,000 particles per cubic feet of air at a size equal to or greater than 0.5 microns. This level of cleanroom is sufficient to meet the requirements of many medical device projects and is regularly monitored and certified to remain within tight parameters set by the industry.

In addition to the cleanroom, we utilize positive airflow and other monitoring technologies such as temperature, humidity, particulate and chemical testing, to ensure our cleanroom is free from environmental variables that could potentially interfere with production. We monitor our cleanroom on a daily basis and we are proud to assure our clients that our cleanroom adheres to the highest cleanroom standards.

Frequently Asked Questions

Q: What is the benefit of using an ISO 7 Class 10,000 cleanroom?

A: The ISO 7 Class 10,000 cleanroom helps to ensure that the manufacturing process is free from any potential environmental contaminants or dust particles that could potentially interfere with the production process. With a cleanroom, medical device manufacturers can be confident that their products are being manufactured under the highest cleanroom standards.

Q: How often is the ISO 7 Class 10,000 cleanroom monitored?

A: Laser Dynamics USA monitors our cleanroom on a daily basis and adheres to the highest cleanroom standards set by the industry. We also utilize positive airflow and other monitoring technologies such as temperature, humidity, particulate and chemical testing to ensure our cleanroom is free from any potential environmental contaminants or dust particles.

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