Compounding Cleanroom Services

The room
is the medicine.

USP 797 / 800 compliant cleanroom cleaning for pharmacies, hospitals, and healthcare facilities across the DFW metroplex. Meticulous. Documented. Survey-ready — every visit, every log, every surface.

Aligned withUSP 797USP 800Joint CommissionTSBPISO 14644
Cleanroom technician performing USP 797 compliant cleaning
100%
Client survey pass rate
Live
Laminar Flow · ISO 5
A failed culture. A missed sporicidal cycle. An inconsistent gowning log. Any one of them can pull a compounding license — which is why we treat every visit like the survey is tomorrow.

— The Continental Standard

Chapter One

Three rooms. One journey inward.

Ante Room
ISO 8
01

Ante Room

The first controlled boundary. Where gowning, hand hygiene, and staging happen before anyone or anything crosses into the compounding environment.

≤ 3,520,000 particles/m³
Buffer Room
ISO 7
02

Buffer Room

The compounding room itself. Continuously monitored, sporicidal-treated, and cleaned to a schedule that stays ahead of any inspection.

≤ 352,000 particles/m³
Primary Engineering Control
ISO 5
03

Primary Engineering Control

The hood — the direct compounding surface. Sterile 70% IPA, lint-free wipes, laminar airflow. This is where the drug is made.

≤ 3,520 particles/m³

Chapter Two

Choose your compliance posture.

Tier 01

Silver

Monthly compliance foundation

  • Monthly deep cleaning of ISO-classified areas (Buffer & Ante Rooms)
  • Interior and exterior cleaning of PEC
  • Sterile 70% IPA & non-shedding microfiber on critical surfaces
  • Regulatory-compliant detergent for spills and contaminants
  • Full room sporicidal protocol
  • Wipe-down of supply containers with sterile 70% IPA
  • Trained cleaning technicians
  • Audit-ready documentation of monthly cleaning
Request Silver
Most chosen
Tier 02

Gold

Monitored & sampled — the operator's choice

  • Everything in Silver
  • Monthly surface sampling
  • Air sampling: Categories 1 & 2 CSPs — every 6 months
  • Air sampling: Category 3 CSPs — monthly
  • Smoke observation testing (every 6 months)
  • PEC and SEC certification (every 6 months)
Request Gold
Tier 03

Platinum

Weekly cadence — highest compliance posture

  • Everything in Gold
  • Weekly deep cleaning of ISO-classified areas
  • Weekly exterior cleaning of PEC
  • Sterile 70% IPA + regulatory-compliant detergent
  • Weekly supply-container wipe-down
  • Audit-ready documentation of weekly cleaning
Request Platinum

Chapter Three

The facilities we protect.

Hospital Pharmacies

Sterile compounding areas across acute-care systems

Ambulatory Surgery Centers

Surgical suite and prep-area decontamination

Compounding Pharmacies

503A and 503B facilities under state and federal review

Infusion Centers

IV preparation and CSP staging environments

Continental Cleaning technicians in the field

Chapter Four

Built for the surveyor's clipboard.

Inspection Readiness

Survey-ready for Joint Commission and Texas State Board of Pharmacy on every visit.

Designated Person Relief

We reduce workload for your Designated Person with validated SOPs and documented deliverables.

Post-Construction Decontamination

Disinfectant fogging with the right equipment and PPE — sterilization beyond EVS and internal cleanroom staff.

Trained Technicians

Staff trained specifically for ISO-classified cleanroom environments, gowning discipline, and USP protocols.

Flexible Scheduling

After-hours and weekend cleaning during facility slow hours — no operational disruption.

Emergency Decontamination

Rapid-response decontamination anywhere within the DFW metroplex.

Chapter Five

The standards we answer to.

USP 797
Sterile compounding standard
USP 800
Hazardous drug handling
ISO 14644-1/-2
Cleanroom classification & monitoring
TSBP §291.133
Texas Board of Pharmacy regulations
Joint Commission
Environment of Care standards
EPA-Registered
Sporicidal disinfectant protocols
OSHA 29 CFR 1910
Bloodborne pathogens & HazCom
HIPAA
Patient privacy & information security

Ready for your next survey?

Schedule a free on-site compliance assessment. We'll walk your facility, review your current cadence, and hand back a phase-mapped scope and price.

Chapter Six

Common questions.

It covers the environmental cleaning, disinfection, and sporicidal treatment of ISO-classified compounding areas — Ante Rooms (ISO 8), Buffer Rooms (ISO 7), and the Primary Engineering Control (ISO 5) — using sterile 70% IPA, non-shedding microfiber, and EPA-registered agents on a documented schedule that satisfies USP Chapters 797 and 800.