ISO 13485:2016 Medical Devices

ISO 13485 is designed for use throughout the life cycle of a medical device. It supports each stage of medical device development and operation from initial concept to production and disposal. The standard helps internal and external parties certify and validate processes which maintain the stability of quality management systems (QMS).

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USP 797 Cleanroom Design Sterile Compounding

Upgrading a USP 797 Cleanroom to USP 800?

New USP guidelines may present challenges for compounding facilities. Some facilities need infrastructural and mechanical modifications for compliance. System evaluation includes duct systems, HEPA fan filters, differential pressure standards, air monitoring, and external air exhaust equipment.

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Cleanroom Construction FAQ

Definitive Cleanroom Construction FAQ: How much does a cleanroom cost? How does the level of ISO classification impact build and operating costs? How much supporting space will I need for a cleanroom addition or ISO class upgrade? What’s the advantage of a turnkey cleanroom system?

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CleanPro® Softwall Cleanroom Curtains Installation

Softwall cleanroom curtains, sometimes referred simply as “plastic strips” yield ISO Class 10,000 level particle control with minimal construction. This customer required a custom softwall installation that integrated into their existing building structure CleanPro to deliver a softwall cleanroom

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