1. Filter Installation Leak Testing

2. STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala

3. STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala

4. STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala

5. STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala
1. Average person in poor CR garments (coats) generates about
2x106 part/min greater than 0.5 mm and part/min > 5.0 mm.
2. For cleanrooms of ISO class 6 (class 1000) and poorer quality, HEPA filters
are used with turbulent ventilation to meet the cleanroom classification.
3. For cleanrooms of ISO class 5 (class 100), HEPA filters are used with
unidirectional ventilation to meet the cleanroom classification.
4. For cleanrooms of ISO class 4 (class 10) or lower, ULPA filters are used with
STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala

6. STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala
Filter Collection Mechanism - A Review
1. Diffusion: tiny particles which don’t have enough mass to leave the air stream on their
own move randomly in the air stream. This random motion is due to collisions with
other small dust particles and collisions with the molecules of the gas which they
are suspended. If these particles touch a fibre or previously captured particles they
will be held. (Brownian movement causes them to move randomly)
STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala

7. STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala
2. Impaction is when more massive particles leave the air stream due to their own
inertia and collide with a fibre. This will cause them to be imbedded.
STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala

8. STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala
3. Interception is when a particle strikes a fiber as it passes (tangentially). The particle
will also be captured in this process.
STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala

9. STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala
Typical Air Filtration Principles 99 98 95 40 60 70 50 30 20
0.1
1.0
10.0
0.01
RELATIVE EFFECT OF PARTICLE COLLECTION MECHANISMS
OVERALL EFFICIENCY
COLLECTION
EFFICIENCY(%)
DIFFUSION
INTERCEPTION
Remember we have the air filtration principles of interception, impaction and diffusion which yields and overall efficiency of a filter – in this example the overall efficiency is about 40%.
IMPACTION
PARTICLE DIAMETER (MICRONS)
STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala

10. STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala
HEPA Filter Mechanisms
99.999
0.1
1.0
10.0
0.01
99.99
99.97 99 90 50 10
THEORETICAL HEPA FILTER COLLECTION EFFICIENCY
0.3µm
COLLECTION EFFICIENCY(%)
With a HEPA filter, the combined efficiencies give us a theoretical efficiency of 99.97% on 0.3 micrometers. we say theoretical because a French mathematician named LeMur determined this particle size before we had instrumentation to know for sure. With our modern particle counters, we now know that the least filterable size particle is closer to between 0.1 and 0.2 micrometers and HEPA filters now come in many higher efficiencies with the next step up being a 99.99% HEPA…
PARTICLE DIAMETER (MICRONS)
STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala

11. STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala
Why Test a HEPA Filter
HEPA and ULPA filters are like fine china in that they are easily damaged, either in transit, in storage, or upon installation. This is a HEPA filter that has been in service for over 2 years with a major leak.
STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala

12. HEPA Filter rating and Testing Methodology
PARTICLE REMOVING ABILITY , AIR FLOW RESISTANCE and OPERATING LIFE
Integrity (full media scan)
also includes joints, frames, ceiling, gaskets and other seals
You may have a HEPA that is perfect, but a holding device that is a problem. In place testing can detect leaks in gaskets, seals, etc.
STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala

13. STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala

14. STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala

15. HEPA Filter Integrity Testing
Laskin nozzle generator
This is a typical Laskin nozzle generator for aerosolizing poly alpha olahfins (POA) used for challenge testing. Compressed air is forced through small submerged nozzles and these in turn produce a smoke-like aerosol.
STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala

16. STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala
HEPA test
Manufacturer's factory and packed OK
Unpacked and fitted into the filter housings maybe damage
Leakage problems
casing
housing
Testing : artificial test aerosol
STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala

17. Leakage areas in a HEPA filter
A - filter paper-to-case cement area C- gasket
D - frame joints. B - filter paper (often at the paper fold)
STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala

18. Gasket and casing leaks from filter inserted up from cleanroom
Gasket leaks from filters
inserted down from ceiling
STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala

19. Figure 12.4 Filter-housing gel seal method
STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala

20. Artificial Smoke and Particle Test
Cold-generated oils
Di-octyl phthalate (DOP)
oily liquid, potentially toxic effects, no longer used
Di-octylsebacate (DOS)
poly alpha olefin (PAO)
STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala

21. Cold-generated oil Test
Air+
oil particle
Laskin nozzle
air
(high pressure)
0.5 mm
Air pump
oil
STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala

22. STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala
Hot generated smokes
inert gas:
CO2
vaporize
Evaporation
chamber
oil smoke
condense
oil
aerosol
0.3 mm
STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala

23. STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala
Hot oil smoke generator
STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala

24. Apparatus for Measuring Smoke Penetration
Photometer
28 1/min (1 ft3/min) of airborne particles
particles refract the light
electrical signal
concentration: between μg/1 and 100 μg/1.
STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala

25. STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala
principle of Particle Counter
STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala

26. STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala
Single particle counters
sample a volume of air and this is collected in a set time
STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala

27. STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala
Particle Counter
STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala

28. Methods of Testing Filters and Filter Housings
Scanning methods
a probe with a photometer, or single particle counter,
Scan speed : not more than 5cm/s
leaks : media, filter case, its housing
The most common leaks:
around the periphery of the filter
the casing-to-housing seal,
the casing joints
STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala

29. STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala
Repair of leaks
Filter media leak
at the fold of the paper
repaired on site with silicon
replaced
STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala

30. STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala
Tacky rollers
Tacky rollers are similar in size and shape to paint rollers used in the home, but they have a tacky material around the outside of the roller. An example of a tacky roller is shown in Figure 21.7.
STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala