Table II

Results of Survey on Heat-Resistant Spores Identified in Production Environments of Japanese Manufacturers of Large-Volume Parenteral Solutions

Microorganism^*	Suspension Solution for The Determination of D-Value	Temperature (°C) for Measurement of D-Value	D-Value	D-Value Converted to 105 °C^**
Bacillus cereus	Water for injection	103 101	1.32 0.92	0.83 0.37
Bacillus cereus	Normal saline	102 100 100	0.68 1.90 1.40	0.27 0.60 0.44
Bacillus subtilis	Water for injection	102 103 100 100 100	1.44 0.87 1.69 1.46 1.23	0.72 0.55 0.53 0.46 0.39
Bacillus licheniformis	Normal saline	100	0.90	0.28
Bacillus licheniformis	Water for injection	100	0.82	0.26
Bacillus amyloliquefaciens	Water for injection	100	1.29	0.41
Bacillus lentus	Normal saline	100	1.20	0.38
Bacillus circulans	Water for injection	100	0.96	0.30
Brevibacillus nitrificans	Water for injection	102	0.60	0.30

* Heat-resistant microorganims identified by member companies of the Intravenous Solutions Society in their production environments or in their presterilized products. The survey was conducted by the Intravenous Solutions Society, Japan (survey period: 2012 to 2014).
↵** These conversion were calculated by using 10 °C for z-value.