Storage and laboratory handling

Start with the supplied documentation

Storage requirements are material- and batch-specific. Follow the product label, batch documentation and the approved laboratory protocol. Do not replace a stated condition with a general rule found online.

Temperature, light, moisture, container closure and time can all influence stability. Where the documentation is unclear, quarantine the material until an appropriate laboratory decision is made.

Control the environment

A storage temperature is meaningful only when the environment is monitored. Laboratories should use suitable equipment, record temperatures and have a process for reviewing excursions. Avoid repeated temperature cycling and keep materials protected from unnecessary light and moisture.

• Use a suitable monitored storage unit
• Keep containers sealed and clearly identified
• Record receipt, storage location and movements
• Separate quarantined or compromised material
• Document and assess temperature excursions

Handling and traceability

Use clean, appropriate tools and a controlled workspace. Record who handled the material, when it was opened or prepared and any relevant observations. Good records reduce mix-ups and help an investigation if a result later appears unusual.

Do not use material when the seal is compromised, the label cannot be reconciled, or there are unexpected visible changes without an approved assessment.

Stability supports storage claims

The TGA describes stability evidence as part of quality control used to justify shelf life and storage conditions for regulated medicines. While FCW research materials are not presented as approved medicines, the general lesson remains useful: storage claims should be tied to appropriate evidence and documentation, not assumption.