Independent collagen data and a complete file.

A certificate of analysis shows that a material passed. It does not show how one lot compares with the last, or with another supplier’s. Alpstein reports measured values for every lot and has Intertek, Oxford and Cambridge test consecutive batches for purity, structure and consistency. Those results ship alongside the release file.

COA · TRC · TSE · END

Certifications and quality systems

Certificate

ISO 13485ISSUED — · PENDING

Certificate

GMP statusISSUED — · PENDING

Certificate

Master file arrangementsISSUED — · PENDING

Certificate

AdditionalISSUED — · PENDING

Pending: certifications held or in progress, with issue dates

Documentation shipped with every batch

COACertificate of analysis

TRCTraceability record

TSETSE and BSE statement

ENDEndotoxin data

Pending: additional documents per founder; whether to name the independent laboratories and university partners

Independently analysed

COA · TRC · TSE · END

Consistency between deliveries

Batch to batch consistency is a claim until a customer can check it. Four things make it checkable.

01One specification, measured valuesEvery certificate of analysis reports the measured value for each parameter, not pass or fail. Two certificates can be set side by side.

02Lot history on requestThe values for every lot a customer has received, so a delivery can be read against the ones before it.

03Independent multi batch studyIntertek tests consecutive batches for identity and purity. Oxford and Cambridge test structure and mechanical properties. The laboratories have no stake in the result.

04Retained samplesA sample of every lot is retained, so a question about a delivery can be answered by testing the lot itself.

Pending: confirm lot history access and retained samples with Andy before publishing

Release through Switzerland

Release testing and certification run through Alpstein Biotech AG in Switzerland.

Pending: word to whatever the founder confirms Switzerland actually does

Supplier audits are welcome.

Customer quality teams can visit the line by arrangement.

Pending: keep only if the founder will honour the invitation

Request the quality documentation pack

Request the documentation pack