Environmental Monitoring Services

Cleanroom Preventative Maintenance
Preventative Maintenance

 

Regularly-Scheduled  Maintenenace Keeps Your Cleanroom Running. Your business and your reputation depend on the cleanliness of your facility. A regular scheduled maintenenace program is essential to assure that your facility is running at its peak. Cleanetics experts can provide the best in equipment and room maintenace. Below are some of the many services we can provide to our clients:

  • Certification to ISO Standard 14644-1

  • Inspect all equipment for proper operation

  • Clean/replace FFU/HEPA pre-filters

  • Aerosol filter scan

  • Return air risers and wall cleaning

  • Change the pre-filters on the air handler

  • Air handler drive belt replacement and  bearing lubrication

  • Clean all refrigerator condenser coils

  • Condensate pan sanitizing briquettes

  • Sensor calibration

  • Particle counter calibration

  • Clean down room according to current regimen

  • Review cleaning procedures for compliance 

Quarterly, Semi-Annual, or Annual Service Packages Available.  Cleanetics will assess and customize your preventative maintenance contract to meet the needs of your cleanroom

Viable Monitoring Services
Cleanroom Viable Monitoring

Viable sampling is an important component of the maintenance of any clean environment.  Cleanetics offers a fast and convenient way to accurately determine viable microbial levels of any clean environment used for medical, pharmaceutical, or advanced research purposes.

 

 Regular sampling by Cleanetics allows you to monitor trends in the presence of viable organisms, thus helping you evaluate the effectiveness of your cleaning and standard operating procedures.  Surface sampling is used in conjunction with air sampling to provide information on bio-aerosol dispersal and deposition, as well as to locate and identify bio-contaminant sources.  

Cleanetics offers microbiological services scaled to meet the needs of all of our USP 797/503 clients.  Design and execution of a USP 797/503 environmental sampling plan is a task that requires attention to detail, extensive knowledge of the tests required and precision in reporting the data.

 

Cleanetics is dedicated to providing the technical expertise and laboratory capabilities necessary to meet the challenge of implementing a rigorous USP 797 program, which requires sampling, at minimum, every 6 months.  Analysis is preformed by a professional and accredited, GxP compliant laboratory.

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Cleanroom Certifications

 

Cleanetics helps advance clean technology by providing solutions for critical process environments. Helping customers ensure regulatory compliance, enhance safety of products, and improve quality is Cleanetics’ mission. 

Adhering to all ISO Standards, Cleanetics will certify your cleanroom meets:

  • Particle Count

  • Temperature

  • Relative Humidity

  • Pressure Differential

  • Air Flow

Full detailed reports are completed in a timely manner

Viable Sampling
Cleanroom Viable Monitoring 

 

  • Analysis of Total Microbial Count  (# of CFU)

  • Identification of each colony type (Genus Level)

  • Incubation and analysis of samples compliant with:  USP 797, 1116 and ISO 14698

  • Guaranteed 4 week turnaround

  • Immediate notification of Gram-negative rods, coagulase positive staphylococcus, molds and yeasts