Under LOW RISK conditions, solid frozen state at -20 C stored without sterility testing for how many days?

• A. 15 days
• B. 60 days
• C. 30 days
• D. 45 days

Answer: (D)

In low-risk sterile compounding, how long you can store a product depends on the temperature and whether sterility testing is performed. When the material is kept in a solid frozen state around -20°C, it’s considered frozen storage, which minimizes microbial growth and chemical changes. Under these conditions, the maximum storage time without sterility testing is 45 days. This aligns with guidance that freezing at -25°C or colder typically allows about 45 days for low-risk products without sterility testing. If you need to store longer, sterility testing or other stability data would be needed. For comparison, refrigeration at 2–8°C is about 14 days, and room temperature (~25°C) is roughly 48 hours.