Clean Rooms & Regulated Manufacturing

Pharmaceutical Manufacture & Storage • Medical Devices • Semiconductor & Delicate Instruments

One system continuously monitors the environment in cleanrooms as well as the condition of the supporting infrastructure. SmartScan can be used to implement a Clean Room Monitoring System that is fully cGMP-Compliant including Temperature and Humidity Monitoring, Differential Pressure Monitoring, and Airborne Particle Monitoring. The system meets ISO 14644 requirements and conforms to the data integrity stipulations specified in FDA 21 CFR Part 11.

ISO 9001/2015 Certificate ISO/IEC 17025:2017 Certificate

Suggested Monitoring Points

SmartScan Features That Keep Your Cleanroom Compliant with Ease

• MOBILE & WEB-BASED USER INTERFACE:
A simple web browser is all that you need to interface with SmartScan.
• USE EXISTING NETWORK INFRASTRUCTURE
Significantly reduce the installation cost and minimizes the disruption to current operations.
• REQUIRES MINIMUM IT INVOLVEMENT
Your company already supports the IT infrastructure and we’ll support the SmartScan application. You can host the system or we also offer a Cloud hosted option.
• DATA LOSS PREVENTION
No measurement data is ever lost due to network interruptions because of the SmartScan system’s fault tolerant design.
• MEETS REGULATORY REQUIREMENTS
Meet all the requirements contained in FDA 21 CFR Part 11, EU Annex 11, and ISO 14644. In addition, a variety of standard reports quickly give auditors what they need.
• EASILY VALIDATED
Our inexpensive but solid validation methodology can be easily and completely validated in days, not weeks.
• ENTERPRISE WIDE
Monitor facilities spread nationwide all with the same system. Access is easily restricted to individuals on a “need to know” basis.