HACCPLAN

FREEZE-DRYING (LYOPHILIZATION)

Preservation (Non-thermal)

Freeze-Drying (Lyophilization)

Prerequisite

Also: lyophilization · lyo

Removing water by sublimation under vacuum from a frozen product. Preserves structure and heat-sensitive nutrients; common for premium dried fruit, mushrooms, coffee, supplements.

Typical Hazards

B
Biological
Microbial survival (no kill step); rehydration risk if Aw not validated
C
Chemical
Vacuum-pump oil migration
P
Physical
Tray / shelf fragments

Typical Controls

Final Aw verification
Vacuum pump isolation from product zone
Pre-freeze-dry pathogen control if RTE

Regulatory Citations

2 cross-references across 2 documents

21 CFR Part 117

21 CFR Part 117 · § 117.80
Process controls

21 CFR Part 111

21 CFR Part 111 · § 111.95
Supplement operations

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