01
What lyophilised means
Lyophilisation, also called freeze-drying, removes water from a frozen material under reduced pressure. The resulting dry material may be easier to store and handle than a prepared solution, but lyophilisation does not make every material stable under every condition.
Temperature, moisture, light, oxygen, container closure and time can still affect a material. Exact requirements should therefore come from the applicable supplier information, batch record and validated laboratory procedure.
02
Receipt and initial inspection
On receipt, the laboratory should compare the product identity and container details with the order record, inspect the packaging for visible damage or loss of closure integrity, and record the date and condition received.
Quarantine or investigate a container if its identity is uncertain, its packaging is compromised or its transport history falls outside the laboratory's acceptance criteria. Do not rely on appearance alone to determine suitability.
03
Unopened storage
Unless the applicable documentation states otherwise, unopened material should remain sealed, dry and protected from direct light, excessive heat and moisture. It should be stored in a controlled location with access and inventory records appropriate to the organisation.
Do not invent a storage temperature from a general web page. Where exact conditions are not available, obtain the supplier information before deciding the laboratory's storage plan.
04
Laboratory preparation
Any preparation should follow an approved laboratory method and product-specific solubility information. The method should define the solvent, target concentration, equipment, mixing approach, container and acceptance checks.
Prepared material should be labelled with enough information to preserve identity and traceability, including the material name, concentration, solvent, preparation date and internal reference where applicable. Repeated temperature cycling and unnecessary exposure to light, heat, moisture or air should be minimised where the validated method requires it.
05
Maintain traceability
The laboratory record should connect the received container, any available batch or lot reference, supporting documents, preparation record and resulting samples. Secondary containers and aliquots should not lose that connection.
This guide provides general laboratory information only. It is not a substitute for a safety data sheet, supplier instruction, batch-specific document, risk assessment or validated standard operating procedure. These materials are not for human or veterinary use.