Modular cleanrooms, 21 CFR Part 11 documentation, and controlled storage for pharma, biotech, and medical device companies. 40% less cost than traditional construction.
ISO 7 Cleanroom Installation
FDA Compliant • HEPA Filtration • 21 CFR Part 11
"Outstanding service every time. Communication is flawless. They make us feel like a priority!"
— Martha Molina, Google Review
These challenges cost life sciences companies millions in delayed launches and failed audits.
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.
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.
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.
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.
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.
Over 10 years of outstanding service and support. The cost for services provided is an outstanding value.
HIPAA, 21 CFR Part 11, and storage optimization resources for life sciences.
A practical 10-point HIPAA checklist healthcare organizations use to verify records storage, access controls, and audit-readiness for protected health information.
How facilities managers reclaim 30–50% of warehouse and records-room space using high-density shelving, mezzanines, and slotting analysis.
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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