Sterile Peptide Lyophilisation
Manufacturing Standards
Ten controls govern every peptide lot we produce — from incoming identity and purity through lyophilisation, release testing and moisture-tight distribution.
01–02
Materials & Components
Incoming peptide qualification
Identity, purity and related-substance profile confirmed on every incoming lot before it enters the process.
Depyrogenated vials, proven closures
Dry-heat depyrogenation of glass, with closure systems qualified for seal integrity and moisture ingress.
03–05
Lyophilisation & Fill
Validated, mapped freeze-dryers
Documented cycle control per product, with full optimisation of both cycle and formulation.
Residual moisture by Karl Fischer
Acceptance limits set from product stability data, never generic targets.
Uniform fill, controlled environment
Fill-weight uniformity held under monitored humidity and particulate limits.
06
Release Testing — every lot
HPLC / MS
Purity and mass confirmation.
Cake appearance
Structure, colour, collapse.
Reconstitution
Time to clear solution.
Endotoxin
Bacterial endotoxin testing.
07–08
Pack-out & Distribution
Inert headspace, moisture-tight pack
Hygroscopic cakes sealed under inert gas and packed to exclude ambient moisture.
Desiccated storage & shipping
Controlled desiccated conditions end to end, with documented excursion records.
09–10
facilityEquipment & Equipment
Validated cleaning & sterilisation
Cleaning, sterilisation and depyrogenation validated for all product-contact equipment.
Full ISO 5 clean room production
All aseptic operations performed within a classified ISO 5 / Class 100 production area.
