Breath specimen collectors, including Exhaled Breath Condensate (EBC) Collectors, must be completely free of particulate and chemical contamination to ensure valid biomarker data. There is a common misconception that standard sterilization methods used in manufacturing various breath collection devices are sufficient for this purpose.
They are not.
Methods like steam autoclaving, irradiation, and chemical sterilization effectively kill organisms but do not remove chemical contamination. They leave behind both chemical residues and organic matter from the organisms. While this might be acceptable for most applications, such as surgical instruments, it is unacceptable for EBC collectors. The compounds of interest in EBC are at such low concentrations that any contamination can lead to false biomarker data and unreliable results.
Ensuring a contamination-free product is paramount to Respiratory Research, Inc., and over the years we have perfected our own proprietary cleaning process. Every RTube™ Exhaled Breath Condensate Collector is rigorously manufactured per this proprietary process. This is the only device we know of which incorporates such care and diligence to ensure a contamination-free collector. No other company does this, and after 25 years and over 230,000 uses, we are pleased to see the RTube widely regarded as the global standard in EBC collection devices.
The RTube is manufactured in an ISO 8 cleanroom within an ISO 13485-certified facility. All cleanroom protocols are followed with masked, gowned, and gloved operators performing the manufacturing process in a very tightly controlled environment. The RTube is manufactured in small batches to minimize assembly time. It is promptly packaged and sealed in the cleanroom to ensure a contamination-free product ready for use in your study.
While our cleaning process is proprietary, we share key highlights with our customers to help them make informed decisions for their studies. Although some steps are omitted to protect our proprietary process, we hope the information provided here addresses most questions.
Step 1: Organic Wash
Scrub and soak all surfaces with organic solvent to kill any organisms and remove organic residues and particulates. Discard and replace solvent with each batch to ensure clean fresh solvent.
Organic Wash
Step 2: Inorganic Wash
Scrub and soak all surfaces with inorganic solvent to remove chemical residues and particulates. Discard and replace solvent with each batch to ensure clean solvent.
Inorganic Wash
Step 3: Dry
Immediately jet-dry using purified air. This process is critical to minimize any atmospheric compounds, particularly oxides of nitrogen, from being re-dissolved into droplets of fluid clinging to the condensation surfaces of the RTube.
Dry
Step 4: Assembly
The RTube is carefully and precisely assembled.
Assembly
Step 5: Packaging
The product label is applied and the completed RTube is immediately sealed in a medical-grade polypropylene pouch. This preserves the RTube in a clean, ready-to-use state until the pouch is opened.
Packaging