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Modular cleanrooms that meet FDA, cGMP, and ISO standards—installed in weeks, not months. Scalable, relocatable, and fully documented for validation.
Review classification, building systems, and site conditions with the Reynolds team
Controlled environments designed around an ISO 7 requirement. Final room, mechanical, monitoring, and testing requirements are defined by the process and project scope.
Our cleanrooms feature 99.99% efficient HEPA filtration, precise temperature and humidity control, and positive pressure environments to maintain your required ISO classification.
Purpose-built air handling systems with precise temperature control, humidity management, and custom air change rates to meet your specific process requirements.
From requirements to certified cleanroom in 30 days. Pre-fabricated panels install with minimal contamination risk.
We evaluate your ISO class requirements, contamination controls, air change rates, and workflow patterns to design a compliant solution.
Our engineers create detailed CAD drawings with HEPA filtration, air handling, pressure cascades, and environmental monitoring specifications.
Wall panels, air handling units, and HEPA systems are pre-fabricated and tested in our facility—minimizing on-site contamination risk.
Our crews install, commission, and validate your cleanroom. Full IQ/OQ documentation and particle count certification included.
From pharmaceutical manufacturing to electronics assembly—we deliver certified cleanrooms for every regulated industry.
Controlled rooms configured around the process, contamination risk, and the operator's quality requirements.
Implant manufacturing, catheter assembly, and sterile device packaging.
Cell culture, tissue processing, and biologics manufacturing in controlled conditions.
PCB assembly, semiconductor handling, and sensitive component manufacturing.
Packaging, ingredient handling, and allergen-control areas designed around the production process.
Cosmetic formulation, filling, and packaging in contamination-controlled environments.
See what these facilities avoided—and achieved
ISO 7 Modular Cleanroom
Answers about ISO classes, FDA/cGMP compliance, installation timelines, and cleanroom relocation.
Schedule a cleanroom assessment. ISO 7/8, full IQ/OQ docs, particle count certification — 30 days.
Schedule Cleanroom AssessmentFree • No obligation • Same-Day response
Some modular wall and ceiling components may be reusable, but relocation is not automatic. The project team must evaluate panel condition, dimensions, utility and HVAC changes, controls, code requirements, disassembly risk, transport, reinstallation, and retesting at the new site before promising reuse.
There is no responsible universal savings percentage or ROI period. Compare project-specific proposals that include design, permits, site preparation, HVAC and utilities, fire protection, finishes, equipment integration, testing, documentation, downtime, future changes, and lifecycle maintenance.
The schedule is project-specific. Room size, classification, site readiness, permits, utilities, equipment integration, and the required testing and documentation all affect delivery. Reynolds establishes a schedule after the requirements and existing conditions are reviewed; there is no universal installation-time promise.
The required ISO class comes from the process, product risk, contamination-control strategy, and applicable quality requirements. ISO 14644-1 defines how airborne-particle cleanliness classes are specified and verified; it does not assign one class to every industry. The owner and quality team should set the requirement before design.
Turnkey scope is defined in the proposal, not assumed. It can include site assessment, design coordination, permits, modular walls and ceilings, HVAC, electrical, fire protection, flooring, installation, testing coordination, and closeout documentation. Confirm inclusions, exclusions, owner-furnished work, and acceptance responsibilities in writing.
A cleanroom can be designed to support an organization's applicable quality and regulatory requirements, but the room is not automatically 'FDA compliant.' ISO classification addresses airborne-particle cleanliness. The owner remains responsible for determining the regulations, quality-system controls, validation, documentation, and operating procedures that apply to its product and process.
Schedule a cleanroom assessment. ISO 7/8, full IQ/OQ docs, particle count certification — 30 days.
Schedule Cleanroom AssessmentFree • No obligation • Same-Day response
Part 11 Compliant
Laserfiche manages FDA 21 CFR Part 11 compliant electronic records—batch records, SOPs, training documentation, and validation protocols in one audit-ready system.
Review the process, required ISO classification, site conditions, building systems, and testing or documentation needs with Reynolds.
A specialist reviews your needs—no auto-responders
We pull case studies from similar projects in your industry
Optional on-site measurement at your convenience
Detailed proposal with transparent pricing—no hidden fees
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FDA-ready cleanrooms in weeks, not months. 55+ years of controlled environment expertise. Full validation documentation included.
Capacity, layout, and project-planning guidance from our facility specialists.
