Conditions That Result in a TRS Score > 100, Thereby Triggering Full Testing. This List Does Not Include All the Possible Conditions That Would Produce a Full Testing Outcome
| Multiplicative Factors | Additive Factors | Total Risk Score (TRS) | |||
|---|---|---|---|---|---|
| Process Factor RFIV | Final Product Factor RFV | Thermodynamic Factor RFII | Kinetic Factor RFI | Material Factor RFIII | |
| 0.1 (Clearance Step) | 0.1 (Lowest Risk) | All Values | All Values | All Values | Always <100, Baseline or General Testing |
| 0.1 (Clearance Step)e | 0.5 (Low Risk)e | 7600a | All Values | All Values | Always ≥100, Full Testing |
| 1300b | RFI + RFIII < 700f | Always <100, Baseline or General Testing | |||
| 1300b | RFI + RFIII ≥ 700g | Always ≥100, Full testing | |||
| 243c | RFI + RFIII < 1757h | Always <100, Baseline or General Testing | |||
| 243c | RFI + RFIII ≥ 1757i | Always ≥100, Full Testing | |||
| 70d | RFI + RFIII < 1930j | Always <100, Baseline or General Testing | |||
| 70d | RFI + RFIII ≥ 1930k | Always ≥100, Full Testing | |||
| 0.5 (Dilution Step) | 0.5 (Low Risk) | 450–7600l | All Values | All Values | Always ≥100, Full Testing |
| 243c | RFI + RFIII ≥ 157m | Always ≥100, Full Testing | |||
| 243c | RFI + RFIII < 157n | Always <100, Baseline or General Testing | |||
| 70d | RFI + RFIII ≥ 330o | Always ≥100, Full Testing | |||
| 70d | RFI + RFIII < 330p | Always <100, Baseline or General testing | |||
| 0.5 (Dilution Step)jj | 1 (Nominal Risk)jj | 243–7600q | All Values | All Values | Always ≥100, Full Testing |
| 70d | RFI + RFIII ≥ 130s | Always ≥100, Full Testing | |||
| 70d | RFI + RFIII < 130t | Always <100, Baseline or General testing | |||
| 27r | RFI + RFIII ≥ 173ll | Always ≥100, Full Testing | |||
| 27r | RFI + RFIII < 173u | Always < 100, Baseline or General testing | |||
| 1 (No Special Steps) | 1 (Nominal Risk) | 450–7600l | All Values | All Values | Always ≥100, Full Testing |
| 243c | All Values | All Values | Always ≥100, Full Testing | ||
| 27r | RFI + RFIII ≥ 73y | Always ≥100, Full Testing | |||
| 27r | RFI + RFIII < 73z | Always <100, Baseline or General testing | |||
| 8x | RFI + RFIII ≥ 92mm | Always ≥100, Full Testing | |||
| 8x | RFI + RFIII < 92aa | Always <100, Baseline or General testing | |||
| 1 (No Special Steps)kk | 2 (Highest Risk)kk | 70–7600v | All Values | All Values | Always ≥100, Full Testing |
| 81–243w | All Values | All Values | Always ≥100, Full Ttesting | ||
| 27r | RFI + RFIII ≥ 23bb | Always ≥100, Full Testing | |||
| 27r | RFI + RFIII < 23cc | Always <100, Baseline or General Testing | |||
| 8x | RFI + RFIII ≥ 42nn | Always ≥ 100, Full testing | |||
| 8x | RFI + RFIII < 42dd | Always <100, Baseline or General Testing | |||
| 2 (Concentrator Step) | 2 (High Risk) | 70–7600v | All Values | All Values | Always ≥100, Full Testing |
| 27–243ee | All Values | All Values | Always ≥100, Full Testing | ||
| 9ff | RFI + RFIII ≥ 14hh | Always ≥100, Full Testing | |||
| 9ff | RFI + RFIII < 14ii | Always <100, Baseline or General Testing | |||
| 8x | RFI + RFIII ≥ 15hh | Always ≥100, Full Testing | |||
| 8x | RFI + RFIII < 15ii | Always <100, Baseline or General Testing | |||
| 1gg | RFI + RFIII ≥ 24oo | Always ≥100, Full Testing | |||
| 1gg | RFI + RFIII < 24pp | Always <100, Baseline or General Testing | |||
Notes:
↵a Solutions with 70% ethanol or higher.
↵b Solutions with 60% ethanol.
↵c Aqueous solutions with pH 1 or lower or 12 or higher.
↵d Solutions with 40% ethanol.
↵e This analysis is also valid for the case of RFIV = 0.5 (dilution step) and RFV = 0.1 (lowest risk).
↵f For example, materials with 1%–10% by weight additives (125), a moderate diffusion coefficient of 5 × 10–10 cm2/sec (40), with processing by heat (50), and with special interest alerts (200) has a RFIII of 415. If the value of RFI was 134, corresponding to 180 days of storage at 20 °C, then RFI + RFIII = 549 and TRS = 92.5.
↵g For example, materials with 1%–10% by weight additives (125), a moderate diffusion coefficient of 5 × 10–10 cm2/sec (40), with processing by heat (50), and with special interest alerts (200) has a RFIII of 415. If the value of RFI was 548, corresponding to 30 days of storage at 40 °C, then RFI + RFIII = 963 and TRS = 113.
↵h For example, materials with 1–10% by weight additives (125), a moderate diffusion coefficient of 5 × 10–10 cm2/sec (40), with processing by heat (50), and with special interest alerts (200) has a RFIII of 415. If the value of RFI was 548, corresponding to 30 days of storage at 40 °C, then RFI + RFIII = 963 and TRS = 60.3.
↵i For example, materials with >10% by weight additives (500), a fast diffusion coefficient of 5 × 10–9 cm2/sec (80), with processing by heat (50), and with special interest alerts (200) has a RFIII of 830. If the value of RFI was 1000, corresponding to 1 day of storage at 60 °C, then RFI + RFIII = 1830 and TRS = 104.
↵j For example, materials with >10% by weight additives (500), a fast diffusion coefficient of 5 × 10–9 cm2/sec (80), with processing by heat (50), and with special interest alerts (200) has a RFIII of 830. If the value of RFI was 1000, corresponding to 1 day of storage at 60 °C, then RFI + RFIII = 1830 and TRS = 95.
↵k For example, materials with >10% by weight additives (500), a fast diffusion coefficient of 5 × 10–9 cm2/sec (80), with processing by irradiation (200), and with special interest alerts (200) has a RFIII of 980. If the value of RFI was 1000, corresponding to 1 day of storage at 60 °C, then RFI + RFIII = 1980 and TRS = 103.
↵l Solutions with 50% or higher ethanol.
↵m For example, materials with 1–10% by weight additives (125), a slow diffusion coefficient of 5 × 10–12 cm2/sec (10), no processing (1), and no special interest alerts (0) has a RFIII of 136. If the value of RFI was 100, corresponding to 1 day of storage at 40 °C, then RFI + RFIII = 236 and TRS = 120.
↵n For example, materials with 0.01–0.1% by weight additives (5), a slow diffusion coefficient of 5 × 10-12 cm2/sec (10), no processing (1), and no special interest alerts (0) has a RFIII of 16. If the value of RFI was 100, corresponding to 1 day of storage at 40°, then RFI + RFIII = 116 and TRS = 89.8.
↵o For example, materials with 1–10% by weight additives (125), a slow diffusion coefficient of 5 × 10–12 cm2/sec (10), no processing (1), and a special interest alert (200) has a RFIII of 336. If the value of RFI was 100, corresponding to 1 day of storage at 40 °C, then RFI + RFIII = 436 and TRS = 127.
↵p For example, materials with 1–10% by weight additives (125), a slow diffusion coefficient of 5 × 10–12 cm2/sec (10), no processing (1), and no special interest alerts (0) has a RFIII of 136. If the value of RFI was 100, corresponding to 1 day of storage at 40 °C, then RFI + RFIII = 236 and TRS = 76.5.
↵q Aqueous solutions with pH 1 or lower or pH 12 or higher or 40% or greater ethanol.
↵r Aqueous solutions with pH 3 or 10.
↵s For example, materials with 0.1–1% by weight additives (25), a slow diffusion coefficient of 5 × 10–12 cm2/sec (10), heat processing (50), and no special interest alerts (0) has a RFIII of 85. If the value of RFI was 100, corresponding to 1 day of storage at 40 °C, then RFI + RFIII = 185 and TRS = 128.
↵t For example, materials with 0.01–0.1% by weight additives (5), a slow diffusion coefficient of 5 × 10–12 cm2/sec (10), no processing (1), and no special interest alerts (0) has a RFIII of 16. If the value of RFI was 100, corresponding to 1 day of storage at 40 °C, then RFI + RFIII = 116 and TRS = 93.
↵u For example, materials with 0.01–0.1% by weight additives (5), a slow diffusion coefficient of 5 × 10–12 cm2/sec (10), heat processing (50), and no special interest alerts (0) has a RFIII of 65. If the value of RFI was 55, corresponding to 30 days of storage at 20 °C, then RFI + RFIII = 120 and TRS = 73.5.
↵v Solutions with 40% or greater ethanol.
↵w Aqueous solutions with pH 2 or lower or pH 11 or higher.
↵x Solutions with 30% ethanol.
↵y For example, materials with 0.1–1% by weight additives (25), a slow diffusion coefficient of 5 × 10–12 cm2/sec (10), no processing (1), and no special interest alerts (0) has a RFIII of 36. If the value of RFI was 55, corresponding to 30 days of storage at 20 °C, then RFI + RFIII = 91 and TRS = 118.
↵z For example, materials with 0.01–0.1% by weight additives (5), a slow diffusion coefficient of 5 × 10–12 cm2/sec (10), no processing (1), and no special interest alerts (0) has a RFIII of 16. If the value of RFI was 55, corresponding to 30 days of storage at 20 °C, then RFI + RFIII = 71 and TRS = 98.
↵aa For example, materials with 0.1–1% by weight additives (25), a very slow diffusion coefficient of 5 × 10–14 cm2/sec (1), no processing (1), and no special interest alerts (0) has a RFIII of 27. If the value of RFI was 55, corresponding to 30 days of storage at 20 °C, then RFI + RFIII = 82 and TRS = 90.
↵bb For example, materials with 0.01–0.1% by weight additives (5), a slow diffusion coefficient of 5 × 10–12 cm2/sec (10), no processing (1), and no special interest alerts (0) has a RFIII of 16. If the value of RFI was 55, corresponding to 30 days of storage at 20 °C, then RFI + RFIII = 71 and TRS = 196.
↵cc For example, materials with 0.01–0.1% by weight additives (5), a slow diffusion coefficient of 5 × 10–12 cm2/sec (10), no processing (1), and no special interest alerts (0) has a RFIII of 16. If the value of RFI was 1, corresponding to 1 day of storage at 5 °C, then RFI + RFIII = 17 and TRS = 88.
↵dd For example, materials with 0.01–0.1% by weight additives (5), a slow diffusion coefficient of 5 × 10–12 cm2/sec (10), no processing (1), and no special interest alerts (0) has a RFIII of 16. If the value of RFI was 19, corresponding to 365 days of storage at 5 °C, then RFI + RFIII = 35 and TRS = 86.
↵ee Aqueous solutions with pH 3 or lower or pH 10 or higher.
↵ff Aqueous solutions with pH 4 or 9.
↵gg Aqueous solutions with pH between 5 and 8.
↵hh For example, materials with 0.01–0.1% by weight additives (5), a very slow diffusion coefficient of 5 × 10–14 cm2/sec (1), no processing (1), and no special interest alerts (0) has a RFIII of 7. If the value of RFI was 19, corresponding to 365 days of storage at 5 °C, then RFI + RFIII = 26 and TRS = 136 to 140.
↵ii For example, materials with 0.01–0.1% by weight additives (5), a very slow diffusion coefficient of 5 × 10–14 cm2/sec (1), no processing (1), and no special interest alerts (0) has a RFIII of 7. If the value of RFI was 2.7, corresponding to 730 days of storage at -20 °C, then RFI + RFIII = 9.7 and TRS = 70.8 to 74.8.
↵jj This analysis is also valid for the case of RFIV = 1 (no special steps) and RFV = 0.5 (low risk).
↵kk This analysis is also valid for the case of RFIV = 2 (concentrator step) and RFV = 1 (nominal risk).
↵ll For example, materials with 0.1–1% by weight additives (25), a slow diffusion coefficient of 5 × 10–12 cm2/sec (10), heat processing (50), and no special interest alerts (0) has a RFIII of 85. If the value of RFI was 100, corresponding to 1 day of storage at 40 °C, then RFI + RFIII = 185 and TRS = 106.
↵mm For example, materials with 0.1–1% by weight additives (25), a moderate diffusion coefficient of 5 × 10–11 cm2/sec (20), no processing (1), and no special interest alerts (0) has a RFIII of 46. If the value of RFI was 55, corresponding to 30 days of storage at 20 °C, then RFI + RFIII = 101 and TRS = 109.
↵nn For example, materials with 0.01–0.1% by weight additives (5), a slow diffusion coefficient of 5 × 10-12 cm2/sec (10), no processing (1), and no special interest alerts (0) has a RFIII of 16. If the value of RFI was 55, corresponding to 30 days of storage at 20 °C, then RFI + RFIII = 71 and TRS = 158.
↵oo For example, materials with 0.01–0.1% by weight additives (5), a slow diffusion coefficient of 5 × 10–12 cm2/sec (10), no processing (1), and no special interest alerts (0) has a RFIII of 16. If the value of RFI was 19, corresponding to 365 days of storage at 5 °C, then RFI + RFIII = 35 and TRS = 144.
↵pp For example, materials with 0.01–0.1% by weight additives (5), a slow diffusion coefficient of 5 × 10–12 cm2/sec (10), no processing (1), and no special interest alerts (0) has a RFIII of 16. If the value of RFI was 1, corresponding to 1 day of storage at 5 °C, then RFI + RFIII = 17 and TRS = 72.