Reynolds modular cleanrooms achieve ISO 7 and ISO 8 certification in weeks—not months. Full FDA documentation and 21 CFR Part 11 compliance included.
ISO 7 Cleanroom Installation
FDA Compliant • HEPA Filtration • 21 CFR Part 11
5.0★ rated across 17 Google reviews — Lehigh Valley's most trusted life sciences infrastructure partner.
These challenges cost life sciences companies millions in delayed launches and failed audits.
Reynolds modular cleanrooms use a typical 2–4 week installation timeline; traditional schedules depend on scope.
Specified HEPA filter efficiency; cleanroom particle counts and classification are verified separately against the approved standard.
Complete electronic records and signature documentation for FDA-regulated environments.
From room temperature to ultra-low. Continuous monitoring with audit trails.
Actual schedules depend on classification, size, validation, and site requirements.
From cleanrooms to documentation systems—everything you need to pass FDA audits and scale operations.
ISO 7 and ISO 8 cleanroom environments installed in weeks, not months. Same performance as stick-built at 30-40% less cost.
Electronic records and signatures meeting all FDA requirements. Document control, training records, and batch documentation with complete audit trails.
Climate-controlled storage for samples, reagents, and reference materials. Temperature monitoring with alarming and documented audit trails.
Comprehensive documentation systems for GMP environments. SOPs, training, deviations, and change control integrated in one platform.
Digitize batch records, validation protocols, and regulatory submissions. Secure chain-of-custody scanning with complete audit trails for FDA inspection readiness.
Electronic document management configured for FDA 21 CFR Part 11 compliance. Electronic signatures, version control, and automated retention for regulated documentation.
Biocoat needed to scale production. Fast.
Biocoat, a medical manufacturer, needed an ISO 7 cleanroom to house a manufacturing process and a new piece of equipment.
Reynolds delivered full scope — design, demolition, and renovation through design and installation of the cleanroom and its HVAC, electrical, sprinklers, and custom flooring. The cleanroom and office were built from modular walls with windows, doors, full electric, ceilings, and flooring.
Reynolds confirms construction, classification, commissioning, operating, and implementation inputs before presenting an outcome.
From compliance assessment to a validated, operational cleanroom—built around your production timeline.
Reynolds audits your cleanroom classification needs, storage layout, and documentation practices against FDA 21 CFR Part 11 and GMP requirements.
ISO 7/8 cleanroom specifications, HEPA filtration, and electronic records workflows are configured around your validation timeline.
Cleanroom components are built off-site and assembled on location, minimizing disruption to ongoing production and research.
We provide the validation documentation and support scope defined for the project, with same-day response from the Reynolds team.
Review common cleanroom, validation, records, and implementation questions. Project-specific requirements are confirmed during discovery.
Share the facility, classification, documentation, or workflow constraint Reynolds should review.
Request a Requirements ReviewScope, schedule, and validation requirements are confirmed after review.
Both modular and conventional construction can be designed around a specified cleanroom classification. The right approach depends on the process, site, utilities, room geometry, operating constraints, change-control needs, and total project scope. Compare project-specific schedule and cost proposals rather than relying on a universal percentage or timeline.
Part 11 governs electronic records and signatures in FDA-regulated industries. Key requirements: unique user IDs, electronic signatures linked to records, audit trails of all changes, system validation documentation, and record integrity controls. Our Laserfiche implementation is configured for full Part 11 compliance.
Yes. We implement document management systems that maintain the complete audit trail FDA expects: controlled SOPs with training acknowledgment, batch record management, deviation and CAPA workflows, and supplier qualification records. Many clients use our pre-audit preparation service.
We design storage systems with proper temperature control: refrigerated compartments (2-8°C), freezer integration (-20°C, -80°C), and room-temperature controlled environments. All with continuous monitoring, alarming, and documented audit trails for regulatory compliance.
Performance testing should follow the agreed cleanroom requirements and test plan. Depending on the project, that may include airborne-particle classification and other tests described in ISO 14644-3. The owner and quality team should define the required tests, acceptance criteria, documentation, and ongoing monitoring responsibilities before commissioning.
Share the facility, classification, documentation, or workflow constraint Reynolds should review.
Request a Requirements ReviewScope, schedule, and validation requirements are confirmed after review.
Research and manufacturing need more controlled environments. Traditional construction takes too long.
Electronic signatures, audit trails, and validation spread across disconnected systems.
Temperature-controlled storage at capacity. Manual tracking creates compliance risk.
This is an excellent company to work with. Very reliable, and staff are very professional and easy to work with.
HIPAA, 21 CFR Part 11, and storage optimization resources for life sciences.
A definitive HIPAA records compliance checklist for healthcare compliance and facilities leaders: the Security Rule controls that protect records (access, audit, integrity), how HIPAA, CMS, and Pennsylvania retention rules stack, the economics of a breach, defensible destruction, the ROT and dark-data problem, and a working audit-readiness checklist.
A definitive guide to warehouse storage optimization for operations leaders: cube versus floor utilization, the real 85 percent target, ABC slotting and the golden zone, honeycombing, vertical and aisle strategy, a worked dollar example, a step-by-step method, comparison tables, and when not to optimize for density.
Tell us about your cleanroom, storage, or documentation needs. We'll provide recommendations that meet FDA and ISO requirements.
A three-question preview of the complete FAQ section.
Both modular and conventional construction can be designed around a specified cleanroom classification. The right approach depends on the process, site, utilities, room geometry, operating constraints, change-control needs, and total project scope. Compare project-specific schedule and cost proposals rather than relying on a universal percentage or timeline.
Part 11 governs electronic records and signatures in FDA-regulated industries. Key requirements: unique user IDs, electronic signatures linked to records, audit trails of all changes, system validation documentation, and record integrity controls. Our Laserfiche implementation is configured for full Part 11 compliance.
Yes. We implement document management systems that maintain the complete audit trail FDA expects: controlled SOPs with training acknowledgment, batch record management, deviation and CAPA workflows, and supplier qualification records. Many clients use our pre-audit preparation service.
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