cGMP · USP 797/800

GMP & regulated environment cleaning

Cleaning for GMP and regulated spaces, planned around your approved site procedures, work windows, and record requirements.

cGMPSite procedures
USP 797/800Aligned
WrittenCleaning records
Gowned operator mopping a GMP suite floor with a two-bucket system beside stainless process equipment
The discipline

Cleaning planned with your quality team

We plan cleaning around your approved procedures. Discuss product selection, contact times, cleaning schedules, records, and review responsibilities with your quality team before work begins.
  • Approved agents & contact timesSporicidal rotation and dwell times matched to your validation
  • cGMP-aware behaviorsFlow, segregation, and material handling that respect the grade
  • Complete documentationSigned logs, lot traceability, and deviation reporting
  • Inspection-ready postureWe prepare for audits as a standing condition, not a scramble
Gloved hand ticking a paper cleaning log on a clipboard outside a GMP suite door window
Scope

Where GMP cleaning applies

A clear, written scope — so everyone knows exactly what “done” means.

Manufacturing

  • Grade A/B/C/D environments
  • Fill-finish & aseptic suites
  • Buffer & media prep
  • Equipment & utility rooms

Compounding & QC

  • USP 797 sterile compounding
  • USP 800 hazardous drugs
  • QC & analytical labs
  • Stability & sample storage

The documentation

  • Per-room signed logs
  • Chemical lot & dilution records
  • Rotation & dwell-time records
  • Deviation & CAPA support
How it works

Built for the validated state

Step 1

Map the grades

We document every room, grade, and the cleaning state it requires.

Step 2

Qualify the program

Agents, dwell times, and rotations are aligned to your validation with QA.

Step 3

Execute to SOP

Trained crews run the validated procedure — same way, every time.

Step 4

Record & review

Signed records, periodic review, and rapid deviation response.

Service practices

How we support your facility

RoutineQuality inspections
OneAccount manager per client
75+Years of combined experience
TrainedCrews, site by site
“
I have worked with Tony Prado for many years.
Gilbert CobianGritstone Oncology, Inc.
FAQ

Questions, answered

We follow yours. Where you need help drafting cleaning SOPs, our team can co-author with your QA — but in a validated environment, your procedures govern and we execute them exactly.

Every cleaning event is recorded against the room, agent, lot, dilution, and dwell time, signed by the technician. Records are filed in your account and available for audit on demand.

Discuss your USP 797 or 800 requirements with our team. We will review procedures, training, equipment, and cleaning boundaries before agreeing a scope.

We document it, contain it, notify your QA per your escalation path, and support root-cause and CAPA. Nothing gets quietly cleaned over.

Still have questions?

Talk to a facilities specialist who actually works in regulated environments — not a call center.

On site with our crews

Hispanic window cleaner on a lift squeegeeing a tall curved glass facade of a biotech building at golden hour
The Add Life Facilities Services team at work across the Bay Area
Motion-blurred auto-scrubber crossing a glass-walled lobby at dusk, sharp operator in navy, light streaks on the floor
Let’s talk

Ready to talk gmp?

Request a walkthrough and a written scope built around your environments and service requirements.

Brushed steel elevator interior being wiped by a Hispanic custodian in navy, reflections warm and clean