STERILIZATION

Sterilization is a validated procedure to render a product free of ALL forms of viable organisms. Methods of sterilisation include: chlorine dioxide (CD), Gamma Ray, Electron Beam and Ethylene oxide (ETO),. See information below on recommended methods. The user must determine, by suitable testing, the correct method on the CleanSpace respirator for their particular application. For advice on sterilization contact the CleanSpace Service Team.

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Before sterilization, remove used filters and insert the CleanSpace cleaning and storage Plug (PAF-0074) and clean the respirator thoroughly to remove foreign material (follow the steps in Cleaning the Respirator).

Work in a clean environment and ensure good hand hygiene. Wear personal protective equipment (PPE) including nitrile or vinyl gloves during the cleaning and sterilization process. Remove the CleanSpace cleaning and storage Plug (PAF-0074) before sterilization.

INFORMATION ON STERILIZATION METHODS FOR ELECTRONIC DEVICES:

Recommended sterilization techniques for CleanSpace Power Unit: Chlorine Dioxide, Gamma Ray and Electron Beam. The other parts (masks, neck support and Harness can be sterilized by the other methods. NOTE: Ethylene oxide is carcinogenic and its use for respirator equipment should be considered carefully before use.

Table 1. Sterilization Methods and Their Compatibility
Sterilization Method Problematic Parameters Compatibility
Chlorine dioxide None There are no adverse effects on electronics or batteries.
Gamma ray Radiation, nuclear waste The radiation can damage semiconductors that are not designed for exposure.
Electron beam Radiation The radiation can damage semiconductors that are not designed for exposure.
Autoclave steam High temperature, humidity Can affect floating-gate memory cells (EEPROM); reduces the lifetime of embedded batteries (if any).
Ethylene oxide Flammability, carcinogen Vacuum can affect embedded batteries.
Vaporized hydrogen peroxide Vacuum Vacuum can affect embedded batteries.
Hydrogen peroxide plasma Vacuum, plasma discharge Vacuum can affect embedded batteries; the RF energy required to generate the plasma may not be compatible to semiconductors.
After cleaning the power unit, use the CleanSpace cleaning and storage Plug (PAF-0074) to prevent contaminates entering the respirator when not in use.

CHARGING: 0˚C to 35˚C in a dry and protected space

STORAGE: –10°C to +35°C (–4°F to +131°F) at <90% relative humidity. Away from direct sunlight

EACH MONTH: We recommend INSPECTING the respiratory for damage, cracks or missing parts. Please check the mask exhalation valve. If tearing or distortion of the valve, the exhalation valves should be changed.

EVERY 6 – 12 MONTHS: Harness and neck pads should be replaced depending on the level of use, every 6-12 months. The masks are made of silicone and resilient to aging and wear and tear. Close inspection of the mask should be conducted at least annually. The Respiratory Protection Standards recommend a fit test annually to confirm the correct fit of the mask

Care should be taken when handling and transporting contaminated equipment.

IMPORTANT: Check your territory’s Guidelines and Regulations for transporting contaminated equipment for your contaminant. This will vary according to the contaminant.

EXAMPLE OF STEPS FOR HANDLING AND TRANSPORT STEPS FOR ASBESTOS OR LEAD CONTAMINATED EQUIPMENT

Reference: Australia Act for Contaminated Waste. ALWAYS consult your specific Territory Regulations and Guidelines.

Assessment: Consult a Health and Safety Specialist, the Receiver and the Transport Company on their policies and guidelines for shipping Dangerous Goods. The Receiver of the equipment must be informed prior to packaging and shipping.

Cleaning & Decontamination: Equipment should be cleaned and decontaminated prior to removal from the contaminated zone (see notes above on decontamination). IMPORTANT: Remove used filters and dispose of according to regulatory guidelines. Use protective equipment to handle the contaminated equipment.

Packaging: Following decontamination, the equipment should be first bagged in a clear plastic bag (1) and then double bagged using a 200-micron (um) plastic bag (2).

Shipping: Packaged equipment must be clearly marked Class 9 Dangerous Goods.

Documentation: Please attach to the shipment documents in this email:

  • Shipping Document: 1 copy of the Shipping Consignment Note/Airway Bill (AWB)
  • Commercial Invoice: 4 copies of the invoice/customs documentation (Declaration of Goods)
  • Class 9 (Dangerous Goods) Diamond Symbol: Located visibly on the outside of the package. If Dangerous Goods labels are not available, symbols can be printed and stuck onto the outside of the package.
  • Hazard Material Information (MSDS): Some shipping companies required the Material Safety Data Sheet (MSDS) of the hazardous material. A copy of the Asbestos MSDS should be printed and so if the transport company asks for it the customer can supply it.

This information is a guide only and should be reviewed thoroughly by your HSE manager prior to selecting the disinfecting product for your equipment and specific application. Please note CleanSpace has not evaluated the effectiveness of any agents with regard to inactivating biological material on these products. IMPORTANT: Components of respiratory systems may become damaged over time with prolonged or extended use of disinfecting products.