Our process
From raw material to released lot
Each lot goes through the same documented steps. Nothing ships until an independent lab confirms it meets spec.
Qualified suppliers
Raw peptide comes only from audited suppliers, and every drum is quarantined on arrival.
Incoming testing
Identity and purity are confirmed before material is released to production.
Controlled environment
Filling happens under ISO 5 laminar flow in a monitored cleanroom.
Independent release
Finished-lot samples go to a third-party ISO/IEC 17025 lab for release testing.
Retained samples
We keep retain vials from every lot for the full retest period.
Cold-chain dispatch
Orders ship insulated with cold packs, and tracking is shared the same day.
How it works
The process, step by step
- 01
Receive & quarantine
Material is logged, labeled and held until incoming tests clear.
- 02
Compound & sterile filter
Solutions are prepared to target concentration and passed through a 0.22 µm filter.
- 03
Fill
Vials are filled and fill weight is checked on a set sampling plan.
- 04
Lyophilize & seal
The validated freeze-dry cycle runs, then vials are stoppered under vacuum and crimped.
- 05
Test & release
HPLC, MS, endotoxin and sterility results are reviewed against spec before release.
- 06
Label, pack & ship
Vials are labeled with the lot and date, packed and shipped cold.
Specifications
- Filtration
- 0.22 µm sterile filter
- Fill environment
- ISO 5 laminar flow
- Release tests
- HPLC · MS · LAL · Sterility
- Retain period
- Through retest date
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