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How every lot is manufactured, tested and released, what our cleanroom certifications mean, and which documents we share with brands evaluating us as a supplier.
A wholesale peptide supplier is only as good as the vial that reaches you. At ICARUS Biologics, quality means three things you can check for yourself: where the finished vial was made, what was tested on the exact lot you receive, and whether the paperwork matches the product.
This page explains how a lot moves from raw material to release, what our facility certifications mean, and which documents we provide to brands and distributors evaluating us as a supplier.
| Stage | What happens |
|---|---|
| 1. API sourcing | The active ingredient is sourced from FDA-registered green list facilities and arrives with the manufacturer’s own certificate of analysis. |
| 2. Manufacturing | Finished vials are formulated, filled and lyophilized at cGMP facilities in California and South Carolina, operating ISO 5 and ISO 7 cleanrooms. |
| 3. Independent testing | Each finished lot is tested by an independent US laboratory for identity and assay by HPLC, bacterial endotoxin and sterility. |
| 4. COA review | The certificate of analysis for the lot is issued, and you can review and approve it before your order ships. |
| 5. Release and shipping | The lot ships with its COA. The lot number on the COA matches the lot number on the vials. |
Testing happens at two stages: the API is tested by its manufacturer, and the finished product is tested by an independent laboratory. Only the second stage is third-party, and it is the one that describes the vial you actually receive. See how to read a peptide COA.
Cleanrooms are classified under ISO 14644-1 by how many airborne particles they allow. The lower the class number, the cleaner the air. An ISO 7 room allows up to 352,000 particles of 0.5 microns or larger per cubic meter of air. An ISO 5 environment allows up to 3,520, a hundred times fewer.
In aseptic filling, the critical work, where open vials are exposed, happens in an ISO 5 environment such as a laminar flow clean bench, inside a room held to ISO 7. Certification is performed by an independent certification company that tests particle counts and airflow and issues a report for each room and each clean bench.
| Classification | Max particles ≥0.5 µm per m³ | Typical use |
|---|---|---|
| ISO 5 | 3,520 | Clean benches where vials are filled |
| ISO 7 | 352,000 | Cleanroom surrounding the filling area |
Aseptic filling follows a written sterile fill standard operating procedure. The aseptic process itself is validated with media fills, where a growth medium is run through the same filling process in place of product and then incubated to confirm that nothing grows. Cleaning and disinfection of the filling areas also follow written procedures.
Brands and distributors evaluating ICARUS Biologics as a supplier can request a due diligence package. It is shared directly with qualified business buyers rather than posted publicly.
| Document | What it shows |
|---|---|
| Certificate of analysis | Independent lab results for a specific lot |
| Cleanroom certification reports | ISO 14644-1 classification of the filling room |
| Clean bench certification reports | ISO 5 classification of the laminar flow benches used for filling |
| Sterile fill SOP | The written procedure for aseptic filling |
| Media fill validation SOP | How the aseptic process is validated |
| API source documentation | FDA green list documentation for the API source facility |
Yes. Every lot of finished product is tested by an independent US laboratory for identity and assay by HPLC, bacterial endotoxin and sterility before release.
Yes. The certificate of analysis for your lot is available to review and approve before the order ships.
ISO 5 is a cleanroom classification under ISO 14644-1 allowing no more than 3,520 particles of 0.5 microns or larger per cubic meter of air. It is the environment used for aseptic filling.
Yes. Qualified business buyers can request our due diligence package, which includes cleanroom and clean bench certification reports and our sterile fill and media fill SOPs.
Book a call and our team will confirm availability and walk you through wholesale pricing.
Research brands, distributors and licensed medical practices. All information is kept strictly confidential.