GMP cleanroom cleaning · ISO Class 5–8
GMP cleanroom cleaning since 2014
We work in classified environments from ISO Class 5 through Class 8. Pharmaceutical and biotech facilities, medical device manufacturers, and any operation that runs a cleanroom, including a single Class 8 room.
- Est.
- 2014
- Class
- ISO 5–8
- Framework
- 21 CFR 211 · 820
- Service area
- Florida, statewide
Services
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Triple Cleaning
A deep cleaning performed in three sequential passes, each with a different sporicidal agent.
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Shutdown / Major Cleaning
A one-time deep cleaning of the full room, top to bottom, performed with the cleaning agent your facility specifies.
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GMP Cleaning Programs
Recurring cleaning under contract, built around your SOP rather than a standard package.
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Post-Construction Cleaning
The cleaning that takes a newly built or renovated cleanroom from construction condition to a state where it can be handed over.
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Facility Maintenance
The same building holds offices, conference rooms, hallways, restrooms, kitchenettes and break rooms, and those areas still sit inside a facility that gets audited.
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Advanced Disinfection
Whole-room decontamination by fogging, using hydrogen peroxide or peracetic acid distributed as a vapor throughout the space.
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GMP Training & Certification
Technicians trained and certified through our own GMP training program before they enter a classified space.
Triple Cleaning
We work top down
Every surface is cleaned unidirectionally with overlapping strokes, never back and forth. We work top down: ceilings first, without contacting HEPA filters, then walls and vertical surfaces from top to bottom. Flat surfaces and floors are cleaned last, starting at the point furthest from the exit and working toward it, so no cleaned area is crossed again.
How we work
- ISO Class 5–8
- Pharmaceutical and biotech facilities, medical device manufacturers, and any operation that runs a cleanroom, including a single Class 8 room.
- 21 CFR 211 · 820
- FDA 21 CFR Part 211 for pharmaceuticals, 21 CFR Part 820 for medical devices, and ISO 14644 with your own SOP where no FDA regulation applies.
- Since 2014
- A GMP cleaning company, cleaning pharmaceutical and biotech cleanrooms to the strictest standard in the industry.
- Insured
- Workers' Compensation and Employer's Liability as required under Florida law, General Liability, and Umbrella coverage. Certificates on request.
- Audit-ready
- Internal audits, client audits and FDA inspections alike. When someone asks what was cleaned, when, by whom, and under what procedure, the answer exists.
Trained and certified before entry
Personnel qualification is not a side note in GMP
It is one of the most frequently cited findings in FDA inspections of drug manufacturers, and when a contractor works inside your classified space, their training becomes part of what you have to answer for.
- 01
Train
The curriculum is drawn directly from Title 21 CFR, covering the regulations themselves and the cleaning operations the technician will actually perform.
- 02
Examine
A written examination of fifteen questions. A technician must answer at least eleven correctly to pass, with a maximum of three attempts, and every attempt is recorded.
- 03
Certify
Only on passing is a certificate issued, and that certificate is filed in the system as documented proof that the individual entering your cleanroom was trained and assessed before entry.
How we work
We do not arrive with our own procedure
We do not arrive with our own procedure and ask you to accommodate it. Your SOP defines the sequence, the agents, the frequencies and the documentation. Where you do not have a written procedure yet, we help you build one and then follow it.
Contact
Based in Tampa, we serve cleanrooms statewide across Florida. Projects in other states are quoted on request.