1 AS 1807.

5 — 2000

Australian Standard ™

Cleanrooms, workstations, safety cabinets and

pharmaceutical isolators—Methods of test

Method 5: Determination of work zone

integrity

1 SCOPE This Standard sets out the method for determining the work zone integrity
and induced air leakage for laminar flow cleanrooms, workstations, laminar flow safety
cabinets and pharmaceutical isolators.

2 REFERENCED DOCUMENTS The following documents are referred to in this

Standard:
AS
1386 Cleanrooms and clean workstations
1386.1 Part 1: Principles of clean space control
1807 Cleanrooms, workstations, safety cabinets and pharmaceutical isolators —
Methods of test
1807.0 Part 0: List of methods and apparatus
1807.6 Method 6: Determination of integrity of terminally mounted HEPA filter
installations
AS/NZS
1716 Respiratory protective devices

3 DEFINITIONS For the purpose of this Standard the definitions given in AS 1386.1
and AS 1807.0 apply.

4 PRINCIPLE The vicinities of all joints, seals and work apertures relative to the
clean work zone are surveyed from within while the exterior is maintained under a high
concentration of aerosol. An aerosol photometer is used to detect potential aerosol leakage
which may be induced or leak into the clean work zone. Aerosol photometer readings in
excess of 0.01 percent are an indication of joint or seal leakage, or induction of
contaminants into the clean work zone.

5 AEROSOL TEST LIQUID A liquid which produces a polydispersed aerosol with

properties for the testing of filter integrity equivalent to those of cold polydisperse di-
octyl phthalate (cold DOP).

6 APPARATUS The following apparatus as specified in AS 1807.0 is required:

(a) Aerosol generator and aerosol delivery hose.
NOTE: The test operator should minimize inhalation of and exposure to the test aerosol,
especially at higher concentrations. A P3 respirator, as specified in AS/NZS 1716, should be
worn for the duration of the test.
(b) Aerosol photometer.

www.standards.com.au © Standards Australia

AS 1807.5 — 2000 2

7 PROCEDURE The procedure shall be as follows:

NOTE: For the purpose of this test, the sensitivity or gain control of the aerosol photometer
should be left at the same setting as that used to establish the 100 percent baseline for
integrity testing of the laminar flow HEPA filter (see AS 1807.6).
(a) Set the air pressure on the aerosol generator to 140 ±5 kPa.
(b) Cleanrooms, workstations, laminar flow safety cabinets and pharmaceutical
isolators Discharge sufficient aerosol at the exterior of the joint or seal from a
distance of approximately 150 mm to ensure the challenge is maintained at 0.1
percent concentration or more, with the photometer setting the same as that used to
establish the 100 percent baseline during integrity testing of the laminar flow HEPA
filter (see AS 1807.6), and scan the interior of the joint or seal from within the
work zone with the aerosol photometer. The probe inlet shall be maintained
approximately 25 mm distant from all surfaces during the scanning procedure
(see Figure 1). Scanning shall commence approximately 3 s after the aerosol cloud
has been directed at the joint.
(c) Laminar flow safety cabinets only
(i) Discharge sufficient aerosol at the exterior of the joint or seal from a
distance of approximately 150 mm to ensure the challenge is maintained at
0.1 percent concentration or more, with the photometer setting as that used to
establish the 100 percent baseline during integrity testing of the laminar flow
HEPA filter (see AS 1807.6), and scan the inside lower edge of the viewing
glass at a distance of 50 mm and on 100 mm centres. Scanning shall
commence at a point 25 mm in from each of the work surface boundaries
(see Figure 2).
The probe inlet shall be directed toward the work access opening during the
scanning procedure and its centre shall be positioned approximately 10 mm
above the lower edge of the viewing glass (see Figure 2).
Operate the aerosol photometer at each test position for at least 10 s. Where
an intermittent penetration reading greater than 0.01 percent above the
ambient concentration is obtained, continue for at least a further 30 s.
(ii) With the aerosol cloud sufficiently discharged at a distance of approximately
150 mm immediately in front of each test position to ensure the challenge is
maintained at 0.1 percent concentration or more, scan the front edge of the
work floor at a distance of 25 mm and on 100 mm centres beginning at a
point 25 mm in from each of the work surface boundaries (see Figure 3).
The probe inlet shall be directed toward the work access opening and its
centre shall be positioned approximately 10 mm above the work floor
(see Figure 3).
Operate the aerosol photometer at each test position for at least 10 s. Where
an intermittent penetration reading greater than 0.01 percent above the
ambient concentration is obtained, continue for at least a further 30 s.

8 REPORT The following information shall be reported:

(a) The test liquid used. If the test liquid is not DOP, the report shall state that the
results may not be identical to those which would be obtained using DOP.
(b) Any joint or seal location(s) where a reproducible indication of aerosol penetration
of the joint or seal exceeding 0.01 percent is measured.
(c) Any test position in the work access opening where the aerosol penetration exceeded
0.01 percent more than an average of once per 10 s during the total test period.

© Standards Australia www.standards.com.au

 3 AS 1807.5 — 2000

(d) If adjustments or repairs have been made during testing, the final test report shall
note this action and shall report the relevant information, as above, before and after
all adjustments or repairs made.
(e) Reference to this Australian Standard, i.e. AS 1807.5.

DIMENSIONS IN MILLIMETRES

FIGURE 1 SCANNING OF JOINTS AND SEALS

www.standards.com.au © Standards Australia

AS 1807.5 — 2000 4

DIMENSIONS IN MILLIMETRES

FIGURE 2 SCANNING OF TOP ACCESS COVER

© Standards Australia www.standards.com.au