Filter Installation Leak Testing

STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala

STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala

STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala

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 300000 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

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

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

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

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

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

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

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

STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala

STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala

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

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

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

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

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

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

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

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

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

Apparatus for Measuring Smoke Penetration Photometer 28 1/min (1 ft3/min) of airborne particles particles refract the light electrical signal concentration: between 0.0001 μg/1 and 100 μg/1. STES, Sinhgad Institute of Pharmaceutical Sciences,Lonavala

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

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

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

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

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

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