Cytotoxic Drug Safety Cabinet (CDSC) Service

Cytotoxic drug safety cabinets (CDSC) are critical in sterility and safety for operators, maintenance personnel and the product. Regular testing of all cabinets should be completed at least once a year to ensure their longevity and functionality.

Some of our specialist services include:

  • NATA accredited testing to Australian Standard AS 2252.5
  • Mechanical Inspection:  This includes the motor/ blower unit, vibration mountings, switch functions, gaskets, pre-filters and HEPA filters.
  • Check for System Integrity:  Challenge for filter leakage to AS 1807:2021 Cl 4.4 and AS 1807.7
  • Ensure the work area is not violated by room air:  Test for induced air leakage in the work zone.
  • Prevent cross contamination in the work area: check and adjust air velocity and uniformity of airflows.
  • Establish HEPA filter life and performance:  measure static pressure of filters and electronic motor current.
  • Check environment factors:  measure light output, sound level and germicidal ultraviolet lamp efficiency.
  • Repair and adjust to specification:  when necessary and whenever possible, on-site repairs are included in our services.


Application

Cytotoxic Drug Safety cabinets (CDSC)  are designed for applications where cytotoxic materials are being used, offering Product, Personnel and Technician protection.

Personnel

Protection of personnel and the immediate surroundings from aerosols, particles or vapours, which may be liberated in the preparation, manipulation and compounding of hazardous products.

Products

Protection of products so that they can be manipulated or compounded aseptically in a clean, controlled environment.

Maintenance

Protection of maintenance and testing personnel from exposure to toxic materials that ,may be found in cabinet filters and internal cabinet surfaces.

It is important to note that Class I & II Biological Safety Cabinets are unsuitable for handling cytotoxic materials that are not inactivated by routine decontamination. This is why it is critical to engage a specialist Service Company such as AES Environmental who is not only familiar with BSC cabinets but also aware of the additional requirements unique to maintaining CDSC cabinets.

TESTING STANDARDS

Critical performance tests

Filter Installation Integrity: Filter integrity is determined by: AS 1807:2021 Cl 4.4 determination of integrity of terminally mounted HEPA and AS 1807.7 determination of integrity of non- terminally mounted HEPA.

Containment at the aperture: Containment at the aperture is determined by either AS 1807:2021 Cl 4.9 air barrier containment or AS 1807:2021 Cl 4.12 air barrier test

Work Zone Integrity: Tested in accordance to AS1807:2021 Cl 4.3 Determination of work zone integrity

Air velocity and uniformity in the workzone: Tested in accordance to AS 1807:2021 Cl 4.1 determination of air velocity and uniformity

Alarm Operational Adjustment: Tested in accordance to preset systems by the manufacturer.

Particle counts: Particle counts are tested at the working positions of the workzone to ISO 14644.1

Operator comfort and safety tests

Vibration: Tested in accordance to AS 1807:2021 Cl 4.6 determination of vibration.

Sound Level: Tested in accordance to AS 1807:2021 Cl 4.7 determination of sound level

Lighting: Tested in accordance to AS 1807:2021 Cl 4.5 determination of illuminance

Ultraviolet radiation: Tested in accordance to AS 1807:2021 Cl 4.10 Intensity of radiation from UV lamps

Carbon filter

All cytotoxic Drug safety cabinets should have a carbon filter fitted to the exhaust of the cabinet to filter 100% of exhaust air volume.

Carbon filters should be replaced annually or in the event of a high risk spill. Please note, removal of all filters should follow the appropriate procedure (see next page for more information regarding disposal/removal).

Filter disposal

Before HEPA a contaminated HEPA is removed, it should be sprayed with an adhesive to trap hazardous material on the filter. After the sealing plate is fitted over the filter face, seal the edges of the sealing plate to ensure all contaminated surfaces of the gasket and filter casting are effectively covered.

To ensure cytotoxic waste is disposed of safely, ALL filters (including HEPA filters, Activated carbon filters and pre-filters) within the Cytotoxic cabinets need to be disposed in the following procedure:

  1. Enclosed filters in a suitable plastic bag, which is then sealed.
  2. Place in a protective bag/carton and seal again
  3. There should be a label on the cart which reads “CAUTION: CYTOTOXIC WASTE. DISPOSE BY HIGH-TEMPERATURE INCINERATION ONLY”
  4. Please note, all HEPA filters (including room exhaust HEPA should be considered as contaminated cytotoxic waste and should be handled/ disposed in the same manner).

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