Average Total and Viable Particle Counts from Typical Cleanroom Materials Recorded by the BioTrak® Sampler. Shown in Parenthesis are the Viable Particle Counts as a Percentage of the Total Particle Counts
| Material | Material Status | Testing Type | BioTrak® Sampler | ||
|---|---|---|---|---|---|
| Number of Particles | |||||
| ≥0.5 μm | ≥5 μm | Viables | |||
| Sterile cleanroom hood (polyester) | Laundered by a specialist cleanroom garment management company, under cleanroom conditions using purified water (<5 cfu/mL). Garment has a total pre-irradiation bioburden of <29 cfu per hood (0.05 cfu/cm2). Sterilised by irradiation to provide a sterility assurance level of 10−6. | Agitated above to release airborne particles into the intake pipe | 32 (3%) | 6 (17%) | 1 |
| Unsterile cleanroom hood (polyester) | Laundered by a specialist cleanroom garment management company, under cleanroom conditions using purified water (<5 cfu/mL). Garment has a total bioburden of <29 cfu per hood (0.05 cfu/cm2). | Agitated above to release airborne particles into the intake pipe | 78 (0.9%) | 14 (5%) | 1 |
| Unsterile cleanroom under-garments (cotton/ polyester) | Laundered by a specialist cleanroom garment management company, under cleanroom conditions using purified water (<10 cfu/mL). Garment has a total bioburden of <5 cfu per 55mm contact plate (0.2 cfu/cm2). | Agitated above to release airborne particles into the intake pipe | 2282 (1.2%) | 178 (24%) | 43 |
| Sterile cleanroom wipe (polyester) | Prepared by a specialist cleanroom garment management company under EU GGMP grade A cleanroom conditions using purified water. Wipe has a total pre-irradiation bioburden of <1 cfu per wipe (0.09 m2) and an endotoxin limit of <1 EU. Sterilised by irradiation to provide a sterility assurance level of 10−6 | Agitated above to release airborne particles into the intake pipe. | 11 (3%) | 3 (11%) | 1 |
| Sterile 70% IPA (aerosol delivery) | Produced using WFI and the solution and propellant filtered via a sterilising-grade filter (0.2 μm) under cleanroom conditions by a specialist company. Solution has a total pre-irradiation bioburden determined to be less than 0.4 cfu per 360 mL. Sterilised by irradiation to provide a sterility assurance level of 10−6. | Liquid sprayed into air near in-take pipe | 19,456 (6%) | 129 (136%) | 176 |
| Sterile glove (latex, and powder-free) | A pre-irradiation bioburden of <5 cfu per glove. Sterilised by irradiation to provide a sterility assurance level of 10−6. | Hands rubbed above the in-take pipe | 765 (9.6%) | 87 (85%) | 74 |
| Ungloved hands | Hand washed approximately 30 minutes before test with biocidal cleaning agent. | Hands rubbed above the in-take pipe | 1748 (0.1%) | 21 (4.8%) | 1 |