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• British Pharmacopoeia Volume IV
• Appendices

Steam sterilisation 

The use of biological indicators intended for steam sterilisation is recommended for the validation of sterilisation cycles. Spores of Bacillus stearothermophilus (for example, ATCC 7953, NCTC 10007, NCIMB 8157 orCIP 52.81) are recommended. The number of viable spores exceeds 5 × 105 per carrier. The D-value at 121 °C exceeds 1.5 min. It is verified that exposing the biological indicators to steam at 121 ± 1 °C for 6 min leaves revivable spores, and that there is no growth of the reference micro-organisms after the biological indicators have been exposed to steam at 121 ± 1 °C for 15 min.

Dry heat sterilisation 

 Spores of Bacillus subtilis (for example, var. niger ATCC 9372, NCIMB 8058 or CIP 77.18) are recommended for the preparation of biological indicators. The number of viable spores exceeds 1 × 105 per carrier and the D-value at 160 °C is approximately 1 min to 3 min. Dry heat at temperatures greater than 220 °C is frequently used for sterilisation and depyrogenation of glassware. In this case, demonstration of a 3 log reduction in heat resistant bacterial endotoxin can be used as a replacement for biological indicators.

Ionising radiation sterilisation Biological indicators may be used to monitor routine operations, as an additional possibility to assess the effectiveness of the set dose of radiation energy, especially in the case of accelerated electron sterilisation. The spores of Bacillus pumilus (for example, ATCC 27.142, NCTC 10327, NCIMB 10692 or CIP 77.25) are recommended. The number of viable spores exceeds 1 × 107 per carrier. The D-value exceeds 1.9 kGy. It is verified that there is no growth of the reference micro-organisms after the biological indicators have been exposed to 25 kGy (minimum absorbed dose).

Gas sterilisation 

The use of biological indicators is necessary for all gas sterilisation procedures, both for the validation of the cycles and for routine operations. Gas sterilisation is widely used for medical devices, isolators, chambers, etc. Use for such purposes is outside the scope of the European Pharmacopoeia. The use of spores of Bacillus subtilis (for example, var. niger ATCC 9372, NCIMB 8058 or CIP 77.18) is recommended for ethylene oxide. The number of viable spores exceeds 5 × 105 per carrier. The parameters of resistance are the following: the D-value exceeds 2.5 min for a test cycle involving 600 mg/l of ethylene oxide, at 54 °C and at 60 per cent relative humidity. It is verified that there is no growth of the reference micro-organisms after the biological indicators have been exposed to the test cycle described above for 60 min and that exposing the indicators to a reduced temperature cycle (600 mg/l, 30 °C and 60 per cent relative humidity) for 15 min leaves revivable spores. Exposing the indicators to 600 mg/l of ethylene oxide at 54 °C for 60 min without humidification must leave revivable spores to ensure that the biological indicator is able to reveal insufficient humidification.