GMP & Cleanroom Cleaning (DC • MD • VA)

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• GMP-literate technicians: Trained on gowning, aseptic behaviors, material transfer, and data integrity (ALCOA+).
   
• Validated SOPs: Clearly defined methods, tools, disinfectant rotations, acceptance criteria, and change control.
   
• Audit-ready documentation: Timestamped logs, lot tracking, deviations/CAPAs, and supervisor sign-off—organized for quick retrieval.
   
• Consistent results: Cleanroom-compatible tools, HEPA filtration, microfiber systems, and color-coded workflows to prevent cross-contamination.
   
• Local coverage: Rapid support across Washington DC, Maryland, and Northern Virginia.
   

• ISO Class 5–8 cleanrooms (construction, start-up, and operational)
   
• Aseptic processing suites and support areas
   
• Compounding pharmacies (USP <797> sterile, <800> hazardous)
   
• QC/analytical labs, packaging lines, warehouses
   
• Device, biotech, cell & gene therapy, and R&D facilities

• Approved chemicals & rotation: quats, alcohols, and sporicide (e.g., hydrogen peroxide/peracetic) on a defined rotation to mitigate resistance.
   
• Contact times: enforced dwell times per label; wet-edge technique to maintain surface wetness.
   
• Wipe down sequence: Ceilings → walls → equipment exteriors → work surfaces → floors, clean to dirty, high to low, least to most soiled.
   
• Single-direction wiping: overlapping passes; fresh microfiber faces to minimize redeposit.
   
• Tool control: cleanroom mops, lint-free wipes, low-lint heads; pre-saturated options where required.
   
• HEPA filtration: vacuums with tested HEPA (per manufacturer spec) for particle control.
   
• Material transfer: double-wipe protocols at pass-throughs; labeled quarantine vs. released areas.
   

• Logbooks & e-logs: date/time, area, ISO class, task, product/lot, contact time, tech initials, supervisor sign-off.
   
• Deviations & CAPA: documented root cause, immediate correction, preventive actions, and effectiveness checks.
   
• Change control: versioned SOPs; training sign-offs tracked by employee and SOP ID.
   
• Metrics: visual acceptance, residue checks, optional ATP (if specified), and customer particle/bioburden trends referenced in reviews.
   
• Audit support: rapid retrieval of records; pre-inspection walkthroughs and mock-questions for staff readiness.
   

• Gowning levels: from lab coats and bouffants to full sterile gowning per room classification.
   
• Entry behaviors: no jewelry/cosmetics, controlled movements, hand/arm sanitization, and tool staging.
   
• Safety: OSHA HCS, SDS availability, chemical labeling, and secondary containment.
   
• Waste: compliant segregation and bag-out; haz-drug protocols for USP <800> areas.
   

Week 0 – Assessment
Site survey, risk mapping by room class, review of your SOPs, chemicals, EM plans, and documentation needs.

Weeks 1–2 – Program Stand-Up
Finalize scope and frequencies; approve SOPs, work instructions, and log templates; train assigned staff on your site specifics.

Go-Live – Stabilization (30–60 days)
Close gaps, tune frequencies, and confirm acceptance criteria. First quality review at day 30 with action items.

Ongoing
Monthly quality reviews; quarterly change control review; annual re-training and SOP refresh.

• Pre-inspection readiness (mock audit, document indexing, interview coaching)
   
• Post-event terminal cleans (construction, water intrusion, maintenance)
   
• After-hours or escorted programs for high-security spaces
   
• Coordination with EM providers (you own the microbiology; we align our methods to your EM trends)
   

• Pharmaceutical & Biotech: batch changeovers, suite turnarounds
   
• Cell & Gene Therapy: small-footprint ISO 7/8 with ISO 5 PECs
   
• Medical Device: particulate control for assembly and packaging
   
• Compounding Pharmacies: daily PEC disinfection, buffer/ante maintenance, monthly deep cleans
   

Washington, DC • Maryland • Northern Virginia
Rapid response across DC, Montgomery/Prince George’s, Baltimore corridor, and NoVA.

Do you bring your own disinfectants?
Yes—either our validated list or yours. We track product names, EPA registration, and lot numbers, and we adhere to labeled contact times.

Can you work under our SOPs?
Absolutely. We can adopt yours, map ours to yours, or co-develop site-specific work instructions through change control.

How do you prove what was cleaned?
Every task is logged (date/time/area/tech/product/lot/contact time). Supervisors verify; deviations trigger CAPA.

Will you help us prepare for audits?
Yes—document readiness, mock-audit walkthroughs, and staff coaching are available. We don’t speak on behalf of QA, but we make sure cleaning documentation is inspection-ready.

Do you handle EM (microbial) testing?
We don’t perform EM; we coordinate with your QA/EM partners and mirror methods that support your contamination control strategy.

Ready for an audit-ready cleaning program?
Ask for a no-cost GMP Site Assessment and SOP review.
Call: (202) 780-7755 • Email: info@mrbioclean.com • Get a Quote → /contact

• Meta Title: GMP & Cleanroom Cleaning | cGMP, USP <797>/<800> | DC–MD–VA
   
• Meta Description: Audit-ready GMP cleaning for pharma, biotech, and compounding pharmacies. Validated SOPs, disinfectant rotation, gowning, and full documentation. Serving DC, MD & VA.
   
• URL Slug: /gmp-cleaning/
   
• H1: GMP & Cleanroom Cleaning (DC • MD • VA)
   
• Internal Links: Disinfection Services; Cleanroom Floor Care; Industries → Life Sciences; Contact
   

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