AdvanceTEC is the industry leading design & build cleanroom and process integration provider where experts with decades of segment experience apply the latest digital tools and technologies to deliver outstanding outcomes for customers. AdvanceTEC has a proven track record of addressing project schedule, mechanical systems and modular system integration requirements for leading edge Biotech and Pharmaceutical cleanrooms. From venture backed start-ups to publicly traded global biotech leaders, AdvanceTEC can help you reach your objectives, whether it’s a new build, upgrades, repurpose, expansions or renovations. Segment Expertise In-House: AdvanceTEC brings the in-house expertise to ensure the success of your project: FDA guidelines, EU guidelines, BSL requirements, bag-in bag-out filtration, glass walls, filling lines, downflow booths, cold boxes, quarantine areas, WFI water, modular off-site and on-site integration, glass walls, walkable ceilings, single use strategies. Clinical Trails, GMP Labs, CRO, CMO, High Volume Production. Cleanroom Features - Modular Off-Site Fabrication / On-Site Integration - cGMP cleanroom architectural finishes - Walkable ceiling systems - Glass walls - LED Walk-on light systems - Process utility panels and skid integration - Panelized ceilings - Plenum module and flush grid systems - Resinous flooring systems - Door finishes, operators and hardware - WFI water systems - MALs, PALs and Air locks - Restricted access barrier (RAB) - Down flow booths - Bag-in / bag-out filtration. Facility Types - Gene therapy - Vaccine research and production - CAR-T Cancer - Clinical trial - BSL-1, BSL-2, BSL-3 - Single-use “Disposable” processes - Fill finish - Cell culture suites - R&D applications labs - Modular laboratories - Fill finish lines - Clean storage - Modular support rooms. Cleanliness Classifications ISO Standard 14446 - ISO 4 - ISO 5 - ISO 6 - ISO 7 - ISO 8. European Standard - Grade A - Grade B - Grade C - Grade D - Controlled Non-Classified (CNC). Biosafety Levels - BSL 1 - BSL 2 - BSL 3. Federal Standard 209e - Class 10 - Class 100 - Class 1,000 - Class 10,000 - Class 100,000.
