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USP797 Cleanroom Pharmacies

USP797 & USP800 Standards Now Enforceable

I have been using Cleanetics for a few years now and I would highly recommend their services. Deric and his team are very reliable and knowledgeable and are always available whenever I have a question. I have worked with other companies in the past but none have been as responsive as Cleanetics. As they always tell me "It's my job to care for the patients and their job to take care of the cleanroom. -Salvatore R.,  New Jersey Pharmacist

Contact Us for USP 797/800 Cleanroom Solutions

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USP797 Cleanroom

Partner with Cleanetics to Ensure Your Cleanroom is Compliant. 

November 1, 2023 was the day USP797 and UPS800 Standards became enforceable.How was your facility prepared for the updated regulations? Were you worried about State, JCAHO inspectors?  Did you have   issues with temperature, humidity, pressure differentials, AirChanges, viable or non viable particles?  Or is your cleanroom functioning within the USP797 guidelines?  Cleanetics will assess, advise, and rectify any issues you may be experiencing or maintain the already compliant cleanroom pharmacy.     

Building USP797 & USP800 Cleanrooms Since 2003

Since 2003, Cleanetics has been a leader in the USP797 cleanrooms in design, build, and certify industry.  Our team of experts stay up to date on all USP, State, DOH, and JCAHO regulations.  Having built cleanroom facilities for top hospitals around the nation and globe, Cleanetics ensures compliancy. 

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Cleanroom Environmental Monitoring for Viable Growth

Let Cleanetics Worry about Environmental Monitoring

Are you a functioning USP797 Cleanroom and need to have your room certified or maintained? Our team will work around your demanding schedule to ensure your facility maintains State/DOH/Federal Regulations. When you align your cleanroom with Cleanetics, we alert you regarding certification deadlines and schedule services to keep you compliant.  We believe the pharmacy industry should concentrate on patient CSP's and we concentrate on the cleanroom.  We truly partner with your hospital facility and eliminate the cleanroom stress.

Our mission is to ensure that you are satisfied with a state-of-the-art USP797 Cleanroom & USP800 Cleanroom. The difference between USP797 and USP800 is very important to understand.  Both mandates are regulating the use of cleanroom environments.   USP797 concentrates on the physical environment and USP800 concentrates on protecting the workers in the hazardous cleanroom environment.  Being up to date on both regulations is key to producing sterile compounds safe for patients and safe for the compounding technicians.

Contact Us for USP 797/800 Cleanroom Solutions

USP797 Cleanroom

Building USP797 Cleanrooms Since 2003

Since 2003, our team has been providing USP797 & USP800 cleanrooms to top hospitals across the nation. Our team began consulting, designing, building, and certifying USP797 and USP800 cleanrooms working closely with Directors of Pharmacy to create the ideal Sterile Compounding Cleanroom. With the ever-changing regulations since 2003, the Cleanetics team stays up to date on all the USP and FDA regulations to ensure our clients are in full compliance. We are not just a construction company; we are an extension of our client’s team and have your best interest in mind.

Does your facility have any questions on the recent USP797/800 regulations update?  The revisions are in and will  be enforced by Nov 2023.  Ask us how we can help.

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USP797 Cleanroom Sterile Compounding

We Will Design a Cleanroom That Fits Your Specific Needs

If your facility is renovating an existing space or building a new pharmacy, Cleanetics has the capabilities to complete your cleanroom project. Our specialty is in the design phase to ensure your room will meet all air changes, temperature, relative humidity, and particle count specifications.

Working with top hospitals around the globe, we have created state of the art USP797 cleanrooms & USP800 cleanrooms that follow all guidelines and ensure passing all state inspections. One of our past turn-key design build cleanroom construction projects included a 2,000sq/ft USP 797 & 800 hospital pharmacy. Cleanetics is your one-stop-shop for cleanroom design, construction, and installation, but we can also certify your cleanroom with all necessary organizations so you can confidently operate your facility in compliance with all applicable regulations.

Hire the USP797/800 Experts

Cleanetics Can Renovate Any Existing Location to meet the following regulations:

  • ISO7 Anteroom/Buffer Zone (ISO8 if the facility does not have a shared hazardous and non-hazardous cleanroom)
  • ISO 7 Negative Hazardous Compounding Room
  • ISO 7 Positive Pressure Compounding Room
  • Bio-Gard Wall Laminate: Non-porous, homogenous, heat welded, and durable
  • Custom Manufactured Material Pass Throughs; Hazardous Air-shower Pass Throughs
  • ISO certification guaranteed
  • Passed State, DOH, and Federal Inspections

We Service Our Clients With:

  • Monthly, quarterly, or semi-annual certification packages
  • Certification to ISO Standard 14644-1
  • BSC/LAFW equipment certification
  • Aerosol filter scan/Smoke Challenge Testing
  • Inspection of all equipment to ensure proper operation
  • HVAC inspection and cleaning; Clean/replace FFU/HEPA pre-filters; Clean/replace FFU/HEPA pre-filters
  • Inspection of return air risers and wall cleaning
  • Pressure, Temperature, and Humidity Monitoring
  • A review of cleaning procedures for compliance
  • Microbial Viable Testing (Air Impaction and Surface)

Consult with Cleanetics to build and/or renovate your USP 797 Cleanroom & USP800 cleanroom pharmacy that is guaranteed to pass State, DOH, and Federal Standards.


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