Storage conditions are material- and batch-specific. Follow the current batch documentation and validated laboratory SOP first. When no more-specific instruction has been published, keep sealed lyophilized material cold, dry, protected from light, and under documented control.
Storage by Stage
| Stage | Baseline control | Record to retain |
|---|---|---|
| Receipt | Inspect promptly and move the shipment into the designated controlled environment without unnecessary delay. | Receipt date, condition, lot, quantity, storage location. |
| Sealed lyophilized vial | Keep sealed in the original container, cold, dry, upright when practical, and protected from direct light and repeated temperature cycling. | Temperature log and inventory movement. |
| Opened or prepared material | Use only a validated preparation and stability procedure. Container compatibility, concentration, solvent, sterility requirements, and hold time can change stability. | Preparation record, concentration, date, operator, storage condition, expiry or discard time. |
| Aliquots | Use compatible, clearly labeled containers and minimize repeated opening or freeze-thaw cycling where the validated procedure calls for frozen storage. | Aliquot count, identifiers, preparation and use dates. |
| Temperature excursion | Quarantine the affected material. Do not assume it remains suitable based only on appearance. | Duration, observed range, affected lots, disposition decision. |
Receiving Checklist
- Confirm the package and vial are intact.
- Match the compound, presentation, and lot to the order record.
- Note any cold-chain indicator or packaging issue before discarding materials.
- Photograph damage or suspected excursion evidence.
- Quarantine questionable material and contact AFL before use.
Inventory Practices
First-expiring, first-out
Rotate inventory by the documented retest, expiry, or internal review date rather than by memory.
Separate lots
Do not combine or relabel lots in a way that breaks traceability to the original batch record.
Limit access
Keep storage controlled and accessible only to personnel who can maintain the required records and conditions.