MEDICAL DEVICE CLEAN ROOM STANDARDS

Medical device creation and bundling require the controlled condition of a cleanroom, and these cleanrooms must meet severe necessities. Most Medical Device Clean Rooms must consent to ISO 14644 measures, which confine the quantity of permissible particulate issue in the controlled condition.

Pacific Environmental Technologies, Inc. Plans, develops, and introduces Medical Device Clean Rooms of the highest caliber to fulfill these guidelines. We offer both measured cleanrooms that utilize your current dividers and that are unattached.
Our HardWall cleanrooms offer an elevated level of command over static, weight, tainting, and moistness, and can be intended to conform to the strictest ISO norms. Our Rigid Wall contributions can likewise work for Medical device applications, offering adaptability and flexibility while still ready to fit in with Class 100 guidelines.


Pacific Environmental Technologies, Inc. likewise offers and introduces an assortment of cleanroom lighting choices from standard to course through modules, air filtration frameworks with numerous phases that utilize prefilters and HEPA channels, and laminar wind stream frameworks that can be coordinated with existing HVAC.

A Validation Specialist directs the last finish of a Facility Qualification convention. The review guarantees that the cleanroom is worked as determined and that last documentation mirrors any adjustments required all through the manufacture.
The review initially should confirm and archive office desk work and verify marks. The last cleanroom arrangement should precisely speak to the compositional, mechanical, and electrical drawings including all updates.

A complete agenda records that everything is found as indicated, adequate, and quantifiably checked.

For more data on Medical device cleanrooms or our cleanroom plan and establishment administrations, look at our Cleanroom Design Guide or visit our website.