Controlled environmentProfessional Laboratory Process
ISO 5 controlled work zone
Laminar-flow workstations reduce airborne particulate exposure during controlled processing.
Validated SOPs & traceability
Repeatable procedures and full batch records document materials, processing and checks.
Calibrated precision equipment
Controlled dispensing and calibrated balances support repeatable, verified fill quantities.
Documented aseptic diluents
Sterile diluents supplied with certificates of analysis: bacteriostatic water (0.9% benzyl alcohol) or 0.9% sodium chloride, as specified.
Controlled aseptic filling
Filling with 0.22 µm PTFE vent barriers supports pressure equalisation and controlled air exchange.
Analytical identity & purity checks
HPLC and mass-spectrometry assessment supports peptide identity and purity verification against specification.

