Service model
Fill & Finish
ALDOCHEM performs aseptic filling of client-supplied qualified peptide powder into vials. The material remains the client's property throughout. Filling, controls, and documentation follow a GMP-aligned handling standard at the site in Opole, Poland.
What we do
The client supplies a qualified peptide powder with defined specifications. ALDOCHEM fills the powder into vials under aseptic conditions to the agreed fill weight or volume, then closes, caps, and labels each unit. ALDOCHEM does not synthesize or supply the powder under this service.
- Aseptic filling of client-supplied qualified powder into vials.
- Client keeps ownership of the material throughout the engagement.
- Fill weight or volume set by the client and confirmed at technical review.
- Vial closure, capping, and labelling to the agreed format.
- GMP-aligned handling; research use only.
Process and controls
Each project runs against a defined fill specification. Fill volumes and vial formats are fixed before the batch starts and recorded in the batch record. Filling takes place under controlled conditions with in-process checks.
- Defined fill volumes and vial formats agreed before filling.
- Controlled aseptic filling conditions with environmental monitoring.
- Line clearance and in-process weight or volume checks.
- Batch records covering materials, parameters, and sign-off.
- Full lot-level traceability from incoming powder to filled units.
Documentation and release
Each filled batch is released against its batch record. A Certificate of Analysis carrying a second-reviewer signature is issued where in-scope testing applies.
- Batch record and fill reconciliation per batch.
- Certificate of Analysis with second-reviewer signature where testing applies.
- Reference to the client's incoming qualified material.
- Lot-level traceability and record retention.
- REACH and EU regulatory alignment; GDPR-compliant data handling.
What we need from you
Fill & Finish depends on qualified input material and a clear specification. ALDOCHEM confirms scope and feasibility at technical review before scheduling the batch.
- Qualified peptide powder, client-supplied and client-owned.
- Identity and purity data for the incoming material (Certificate of Analysis or equivalent).
- Target fill weight or fill volume per vial.
- Vial format and closure type.
- Quantity of units required, labelling text, and any handling requirements.
- Confirmation of research-use-only intended use.
Discuss a fill project
Send your material specification, target fill weight or volume, and vial format for technical review.
Filling is carried out at a GMP-aligned manufacturing partner in Opole, Poland, under an ISO 9001-style quality management system. Products filled under this service are for laboratory research only, not for human or veterinary use.