Lyophilisation cycle development and contract freeze-drying, to support the stability of sensitive materials during storage and transit.
Water is often what limits how long a sensitive material lasts. Freeze-drying removes it without heating the product, leaving a stable solid in the vial.
The science
Freeze-drying removes water from a frozen product under vacuum. Instead of melting, ice passes directly to vapour, a process called sublimation. Because the product stays frozen while most of the water leaves, heat-sensitive materials are spared the temperatures that conventional drying would involve.
Cycle development
Cycle parameters depend on the material and the fill format. Dry too quickly and the structure of the product can collapse. Dry too slowly and the cycle costs more time than it needs to.
Cycles are developed for the product and recorded with each batch, so a successful cycle can be repeated.
Checks
Filled vials are stoppered and checked after lyophilisation. Cake appearance gives an immediate indication of how the cycle performed, and moisture checks confirm how much water remains.
Post-lyophilisation results are recorded alongside the cycle and batch records.
Scope, equipment and accreditations for this service are to be confirmed before publication.
The process
Tap through the stages, from assessing the material to checking the finished batch.
Material properties and fill format are reviewed.
Freezing and drying parameters are established.
The batch is filled and lyophilised.
Post-lyophilisation checks are completed and recorded.
Scope
Outputs
Facilities and infrastructure
One company, five locations across the UK, the Netherlands and India. Every service is backed by the same lot records, wherever the work happens.
United KingdomBridgendFormulation, production and manufacturing
ISO 7 accredited
GMP certified
United KingdomWickfordHPLC, analytical testing and freeze-dryingISO 7 accreditedGMP certified
United KingdomThetfordUK warehousing, cold-chain storage and distributionLot-tracked stockCold-chain storage
NetherlandsAmsterdamEU warehousing, cold-chain storage and distributionEU distributionCold-chain storage
IndiaBaddiBiologics facilityBiologicsGood to know
Removing water helps to protect sensitive materials during storage and transit.
The material and its properties, fill volume, vial format and batch size.
The formulation affects how a product dries, so the two are often developed together.
Questions
Removing water helps to protect sensitive materials during storage and transit.
No. Cycle parameters depend on the material and fill format.
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