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Cleanroom Installation and Certification

Beginning stages of an installation of a Stainless Steel BioSafe® Cleanroom
Air Testing and Certification
Comprehensive certification of fan/filter unit performance (flow, electrical and leak testing)
Terra Universal provides flexible installation services. Our technicians can perform the complete installation at your location or direct your team of installers remotely.

In addition, Terra arranges a variety of third-party certifications to help you meet cleanliness requirements and local codes:

FDA/cGMP Certifications: include filter flow and integrity testing designed to help you meet FDA/cGMP requirements for various cleanliness ratings, from ISO 3 to 8 (Fed Std Class 10 to 100,000).

Terra Universal BioSafe® Cleanrooms, like our other freestanding modular cleanrooms, are regarded as electrical/mechanical structures that typically do not require permitting by municipal authorities. However, requirements vary from location to location, and customers should provide Terra with all requirements necessary to meet municipal requirements. To help meet these requirements, Terra provides these additional services, performed by industry-leading test agencies:

• Seismic Load Certification
• Air Balancing Services
• ETL/CSA/CE Certification

Related BioSafe® Pages

BioSafe® Panels: Pre-engineered, modular structures provide smooth, easy clean surfaces
Multi-Room Configurations: internal walls, antechambers, corridors
Ceiling Grid: including fan/filter units (FFUs), lights, ionizing modules
HVAC and Air Control: including ceiling plenum and ducting system
CleanZone™ Powder Containment Modules: create a pharmaceutical powder containment room
BioSafe® Cleanroom Accessories: power and gas connections, sterilization modules, humidity controls and fire safety solutions.
BioSafe® Pass-Throughs and Air Showers: a complete line of interlocked chambers that prevent contamination during personnel or material transfer

File Type File Name Publication Date
Video USP Cleanroom Construction
Time-lapse video showing the installation of a 6' x 10' USP 797 multi-chamber cleanroom. Swing door, windows, flooring, control panel, and ceiling components, including fan/filter units and lighting, are shown.
Video On-Site Hardwall Cleanroom Installation
Video showing installation of a hardwall, modular cleanroom at a customer site. The room is tested at the factory, then shipped overseas to be installed. Framing, paneling and utilities are assembled according to the customer specifications.
Video Modular BioSafe® Hardwall Cleanroom
Installation of a double-wall modular steel cleanrooms, that are ideal for bio/pharmaceutical applications requiring an aseptic environment that stands up to harsh chemicals used for cleaning. This video steps you through the cleanroom's features.
Video Modular BioSafe® Cleanroom Installation Test
Time-lapse installation of a modular BioSafe steel cleanroom with windows, an exit swing door, entryway airshower and 50% ceiling coverage of fan/filter units.
White Paper (PDF) BSL Explanation
Understand Biological Safety Levels (BSL) by reading this summary of the CDC's specifications for working with infectious agents.
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