Cleanroom Certification Services

Preventative Maintenance of USP797 Cleanroom, Outside the cleanroom

Cleanetics Offers Preventative Maintenance Packages

Following the current USP797 & USP800, FDA regulations, State/DOH Standards, and ISO Classifications, Cleanetics can certify your cleanroom according to the evolving standards set forth by these entities. Our packages are offered for bi-annual, quarterly, or monthly services. Having us on your team will alleviate one of the headaches that pharmacists experience. Our goal is to keep your USP797 &UPS800 Cleanroom Pharmacy functioning properly and within regulations. Partner with Cleanetics to breeze through regulator inspections.

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What is offered in our Preventative Maintenance 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 Sampling)

Having a Strong Viable Sampling Program Ensures Product Safety

How can you prove that your cleanroom is not harboring pathogens that are harmful to patients? Microbial Sampling is evidence of your current SOP. Not only can you validate your staffs proper cGMP practices, you can validate the efficacy of your cleanroom filtration system. Tracking microbes and identifying the source is our specialty.

Ask us how we have successfully assisted hospitals in implementing SOP's that eliminated the risk of contaminating CSP's.

Final Reports are completed within 15 days and alerts of failures are given immediately upon over growth of plates. Faster identification, rectification of microbial contamination, and retesting of the cleanroom maintains State, DOH, & Federal Standards for patient safety.

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Call Us:

1-888-692-1115 extension 800

Hours of Operation:

Mon-Fri: 7:30 AM - 4:30 PM

Sat-Sun: CLOSED

Design and Build Office:

814 5th Street
West Elizabeth, PA 15088

Headquarters:

6840 N. Haggerty Road
Canton, MI 48187

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