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1 AS 1807.

26—2004
TM
Australian Standard
Cleanrooms, workstations, safety cabinets and
AS 1807.26

pharmaceutical isolators—Methods of test


Method 26: Determination of air barrier
containment of laminar flow safety cabinets—
Potassium iodide discus test
This is a free 2 page sample. Access the full version at http://infostore.saiglobal.com.

PREFACE
This Standard was prepared by the Australian members of Joint Standards
Australia/Standards New Zealand Committee ME-060, Controlled Environment. After
consultation with stakeholders in both countries, Standards Australia and Standards New
Zealand decided to develop this Standard as an Australian Standard rather than
Australian/New Zealand Standard.
In producing this Standard reference was made to BS EN 12469:2000, Biotechnology—
Performance criteria for microbiological safety cabinets. This test method is technically
identical with the corresponding test method that forms part of BS EN 12469.

FOREWORD
No open-fronted safety cabinet will give complete protection.
The minimum value of aperture protector factor that can be assessed depends upon the
sensitivity of the test, e.g. the size of the challenge (N), the sampling rate, and the smallest
number of particles recovered that can be reliably differentiated from background
contamination.
In this test method, the aperture protection factor, A pf , is calculated separately from each
filter membrane using the following equation:
A pf = NV/104 n
where
V = the sampling flow rate, expressed in cubic decimetres per minute (dm3 /min)
n = the number of spots on the filter membrane
When calculating Apf , if there was one spot on the filter membrane, the protection factor
would be 6.2 × 106 . If there were no spots on the filter membrane this would indicate that
the protection factor was higher than this and the protection factor would be recorded as
A pf > 6.2 × 106 .
The number of potassium iodide particles liberated, N, is calculated using the following
equation:
N = 3.1 × 10 7 × M
AS 1807.26—2004 2

where
M = The volume of potassium iodide solution dispersed by the aerosol
generator, expressed in millilitres (mL)
3.1 × 10 7 = A constant derived from the droplet size, the sampling flow rate and the
speed of the rotation of the disc
The transfer index in Foord and Lidwell (Ref. 1) defines the exposure experienced at a
given point as n/(N × s) where N is the number of particles liberated and n the number
recovered at a sampling rate of s, the sampling being continued to completion. In a room
with turbulent ventilation giving completely uniform mixing throughout the space the
transfer index is equivalent to 1/V, (see Ref. 2) where V is the effective volumetric
ventilation rate including loss by sedimentation. The transfer index has the dimensions
time/cubic length.
The ratio of the transfer indices in the two situations (on the open bench and within the
cabinet) is the protection factor and is dimensionless. For the reference open-bench
This is a free 2 page sample. Access the full version at http://infostore.saiglobal.com.

conditions V, the room ventilation is taken as 10 m 3/min. The Apf then becomes
(N × s)/(10n), with s, the sampling rate, expressed in cubic decimetres per minute
(dm 3 /min). Ideally there should be no escape of hazardous aerosols from safety cabinet, so n
should be zero and the protection factor infinite. However, no open-fronted safety cabinet
will give complete protection and the minimum value of the A pf that can be assessed
depends upon the sensitivity of the test.
Practical values for a test system are N ≥ 3 × 10 8 , s ≥ 20 dm 3 /min and n ≤ 4, which would
lead, for such a system, to a minimum ascertainable value for the A pf of not less than
1.5 × 10 5 .

METHOD

1 SCOPE
This Standard sets out the method for determining the containment of aerosols within
laminar flow safety cabinets using the potassium iodide discus test.
This method specifically applies to Class II biological and cytotoxic cabinets, although it
may have wider application, such as for Class I biological cabinets and fume hood operator
protection verification.

2 SAFETY
This method should be undertaken only following correct testing and adjustment of all
physical functions that could affect the retention efficiency, e.g. HEPA filter integrity,
downflow velocity and uniformity, and exhaust velocity.
This method shall be conducted with all normal air-conditioning systems running to give
actual cabinet retention efficiency.
It is possible that, following testing, the cabinet efficiency may be found to be
unsatisfactory, despite other physical test results indicating the cabinet is performing
correctly. In such cases, the location of the cabinet is unsuitable, due to factors that may or
may not be apparent. To ensure the operator receives an acceptable level of protection, the
cabinet shall be relocated, or the interfering influence modified to prevent interference. In
any case, the cabinet shall not be regarded as suitable for use until retested with a
satisfactory result.

 Standards Australia www.standards.com.au


This is a free preview. Purchase the entire publication at the link below:

AS 1807.26-2004, Cleanrooms, workstations,


safety cabinets and pharmaceutical isolators -
Methods of test Determination of air barrier
This is a free 2 page sample. Access the full version at http://infostore.saiglobal.com.

containment of laminar flow safety cabinets -


Potassium iodidediscus test

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