AS 2252.5:2017 pdf free

AS 2252.5:2017 pdf free.Controlled environments
A documented risk assessment shall be undertaken to determine the level of physical containment that is required for safe operation of the CDSC. This involves an assessment of the potential hazards that may be encountered during the operation and maintenance of the facility.
NOTE: Examples of this type of data include a reference to the barrier requirements noted above.Greater detail is to be found in regional health guidelines for handling cytotoxic drugs. Guidance on risk assessments can be found in AS/NZS ISO 31000.
The front of the cabinet shall include a viewing window extending the full width of the work zone to form a positive seal with the body of the cabinet in the working position.
Materials selected for the viewing window shall be shatterproof and tested and proven to remain transparent and resistant to any change that would prevent clear visibility.It shall be capable of being completely cleaned without removal.
The window should be vertically aligned with the front boundary of the unidirectional airflow outlet. Where a hinged window is used, a means shall be provided to secure the window in the closed position. Where a sliding window is used, means shall be provided to locate the window in the normal operating position. To facilitate cleaning and placement of equipment within the cabinet, means should be provided for holding the viewing window in the open position.
All filter seals, which may come into contact with potentially hazardous materials, shall be under a negative pressure in respect of non-contaminated zones, so that any air bypassing the filter seals flows inwards to the contaminated zones. The exception to this rule is the exhaust carbon filter and additional exhaust HEPA filter, if fitted, which will be sealed to the cabinet. In the event of failure of this seal the capture canopy will ensure removal of any bypass from the room. Regular testing as per Clause 8.6(e) will ensure that the carbon filter seal is integral. Any additional exhaust HEPA filters mounted on the cabinet shall be tested along with the rest of the HEPA filters as per Clause 7.2.1.
NOTE: For an example of a typical air flow arrangement for a CDSC, see Figure 1.AS 2252.5 pdf free download.