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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
"We would have lost a seven-figure contract without Reynolds."
— Director of Operations
These challenges cost life sciences companies millions in delayed launches and failed audits.
Reynolds modular cleanrooms install in 3 weeks vs. 3+ months for stick-built.
HEPA filtration efficiency. Particle counts verified to ISO 14644 standards.
Our clients pass FDA audits first time. 21 CFR Part 11 documentation included.
From room temperature to ultra-low. Continuous monitoring with audit trails.
Biocoat's cleanroom was operational while competitors were still pouring concrete.
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.
Biocoat needed to scale production. Fast.
Horsham, PA
Medical Device Coatings
Biocoat won a major contract for medical device coatings but needed an ISO 7 cleanroom in under 30 days. Traditional construction quotes came back at 3-4 months—they'd lose the contract.
Reynolds designed and installed a modular ISO 7 cleanroom with HEPA filtration, proper gowning sequence, and FDA-compliant documentation. Factory prefabrication meant most work happened off-site while Biocoat prepared their facility.
Every month of construction delay is revenue lost. See how modular cleanrooms accelerate your timeline and reduce costs.
Electronic signatures, audit trails, and validation spread across disconnected systems.
Research and manufacturing need more controlled environments. Traditional construction takes too long.
Temperature-controlled storage at capacity. Manual tracking creates compliance risk.
Over 10 years of outstanding service and support. The cost for services provided is an outstanding value.
Tell us about your cleanroom, storage, or documentation needs. We'll provide recommendations that meet FDA and ISO requirements.
Modular cleanrooms achieve identical ISO classifications to stick-built but install in 2-4 weeks instead of 3-4 months. They're also relocatable if yo...
Part 11 governs electronic records and signatures in FDA-regulated industries. Key requirements: unique user IDs, electronic signatures linked to reco...
Yes. We implement document management systems that maintain the complete audit trail FDA expects: controlled SOPs with training acknowledgment, batch ...
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