USP 797 Compliance Testing

Our service includes all the necessary tests to ensure your pharmacy complies with USP 797. Surface and airborne microbial sampling, ISO-14644 particle counting, air flow testing and filter integrity testing of your Primary Engineering Controls (PEC) and Secondary Engineering Controls (SEC) are among the required tests we perform to help you maintain a clean environment. We evaluate your facility and develop a comprehensive test plan for your anteroom, buffer room, hazardous drug storage area, etc., to meet the rigorous requirements of USP797.

Cleanroom Testing and Classification

Cleanrooms play a critical role in maintaining a contamination free process and end product. Class 1 Air can perform complete cleanroom performance testing to meet and maintain your ISO-14644 Classification. HEPA filter integrity testing, particle count test, pressure differential testing and air exchange rates are some of the tests we perform. Should you have any contamination problems within your cleanroom, we can assist in identifying the source and mitigating the contamination. We provide written documentation for all testing and certificates of compliance. Our equipment is NIST traceable and calibrated annually to provide the most accurate results possible.

BSC Certification

We perform comprehensive field testing for Class I, Class II and Class III Biological Safety Cabinets. Our service technicians are all NSF accredited and can certify, decontaminate and repair your BSCs. We are trained and authorized by all major manufacturers to perform their warranty work. We perform the primary tests required by NSF/ANSI 49; downflow velocity, inflow velocity, HEPA filter leak, airflow smoke pattern, cabinet integrity and site installation; as well as secondary tests to ensure worker comfort. We can also test the intensity of UV lamps to ensure proper efficacy of surface decontamination.

Biological and Molecular Containment

We can perform validation and service of your containment system to ensure it is performing as it was intended. Using trained technicians is the key to performing a successful Bag-In/Bag-Out filter change, test, and/or decontamination. These systems are designed to minimize exposure to harmful material. While in operation, the material is trapped in the filter and contained in the specially constructed housing. These systems should be tested annually to ensure they are providing the safety you depend on. When the filter has reached the end of its life, it needs to be removed and replaced. This is a critically sensitive process that requires specific procedures to maintain a safe environment during change out. Our technicians have been trained and perform service many of these types of systems throughout the Midwest.

Duct Cleaning and Coil Cleaning

Dirty ducts can be a source of allergens for your employees and customers. We can use our video camera inspection system to show interior condition of your ducts. We employ a mechanical cleaning system that thoroughly cleans the ducts. Unlike a high volume or compressed air system that can leave dirt and dust still adhered to the duct walls, our system will loosen these stubborn deposits and remove them with a HEPA filtered collection system. Upon request, we can sanitize the entire duct system with our biocide fogging unit. Dirt and dust can also reduce airflow and heat transfer efficiency of your heating and cooling coils. Get the highest efficiency possible with a clean heating and cooling coil. We can clean and restore the heat transfer surface to reduce your energy consumption. Call us for a free estimate.

 
HVAC/Air Filter Service

Our experts maintain filtration systems based on your needs. The scheduled or “routine,” changing of your air filters is expensive. The ideology of “we change them every 3 months whether they need it or not” approach is very costly in labor and materials. In addition are the long term costs associated with shipping, disposal and energy consumption. We will monitor your systems and change the filters when needed. Don’t be fooled into changing a filter because it “looks” dirty. We take the guesswork out of maintaining your system and use scientific procedures that are available to anyone who chooses to use them.


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