Facility Services Engineered for Regulated Environments.
FGS Labs delivers GMP-aligned cleaning programs, ISO cleanroom maintenance, and contamination-control protocols built to the operational standards your facility requires — not adapted from commercial cleaning.
Standard Janitorial Programs Fail in Regulated Environments.
Biotech and life sciences facilities operate under environmental monitoring requirements, contamination risk assessments, and audit obligations that commercial cleaning vendors are not equipped to meet. A single protocol deviation can compromise batch integrity, trigger a 483 observation, or invalidate environmental monitoring data.
FGS Labs was built specifically for this gap. Our programs are written to your SOPs, executed by trained personnel who understand the difference between a cleanroom and a corridor, and documented to the standard your QA team expects.
Speak with a Facility SpecialistThree Programs. One Integrated Standard.
Each program is scoped to your facility classification, regulatory environment, and operational schedule.
Cleanroom & Controlled Environment Maintenance
ISO Class 5–8 and BSL-2 environments. Procedures written to your classification and validated against your EM baseline.
- ISO 14644-compliant cleaning procedures
- Disinfectant rotation per contamination-control plan
- Gowning room and anteroom maintenance
- HEPA diffuser and surface contact protocols
- Batch-level service documentation
Biotech & Pharmaceutical Facility Services
GMP-aligned programs for R&D labs, pilot plants, and manufacturing support areas. Coordinated with your facilities and EHS teams.
- GMP-aligned janitorial SOPs
- Biocide selection and dwell-time compliance
- Equipment and instrument area protocols
- Waste segregation per EHS requirements
- Scheduled and on-call service coverage
Quality & Compliance Documentation
Audit-ready records maintained to your QMS standard. Every service visit is logged, signed, and retrievable for inspection.
- Completed service logs per visit
- Personnel training records on file
- SOP version control and change documentation
- Corrective action tracking (CAPA-ready)
- QA review-ready reporting package
Built to the Standards Your Auditors Inspect Against.
FGS Labs programs are structured around the regulatory frameworks that govern your facility. We don't apply generic cleaning standards and call them GMP-compliant — our procedures reference the specific guidance documents your QA team works from.
When your next FDA inspection, ISO audit, or internal quality review occurs, your facility maintenance records will reflect a program that was designed for scrutiny.
ISO 14644
Cleanroom classification, monitoring, and maintenance procedures
FDA 21 CFR Part 211
Current Good Manufacturing Practice for finished pharmaceuticals
USP <1072>
Disinfectants and antiseptics in pharmaceutical environments
EU GMP Annex 1
Manufacture of sterile medicinal products
OSHA 29 CFR 1910
Hazard communication and chemical safety standards
CDC / EPA Guidelines
Disinfection protocols and registered product requirements
What a Purpose-Built Lab Program Looks Like
SOP-Driven Execution
Every task is performed against a written procedure specific to your facility. No improvisation. Deviations are documented and escalated — not quietly corrected.
Trained & Qualified Personnel
Staff assigned to your facility complete documented cleanroom behavior training, gowning qualification, and chemical handling certification before their first shift.
Disinfectant Rotation Management
We manage biocide rotation schedules to prevent resistance development, with product selection validated against your contamination-control plan and EM history.
Coordinated with Your QA Team
FGS Labs operates as an extension of your facilities function — not a vendor that shows up and leaves. We attend change control meetings, respond to CAPAs, and update SOPs when your processes change.
Audit-Ready at All Times
Service logs, training records, and product documentation are maintained in a format that can be produced for an FDA inspector or ISO auditor on the same day as a request.
Scalable Across Your Portfolio
Whether you operate a single R&D suite or a multi-building campus, FGS Labs programs scale without introducing inconsistency across sites.
"Your facility maintenance program is part of your quality system. We treat it that way."
FGS Labs · Bay Area, California · Est. 1993
Ready to Assess Your Facility Program?
We'll review your current protocols and identify gaps before your next audit does.