Quality Control system
The system
Four load-bearing walls behind every batch.
Management, testing, analytics and traceability run as four independent systems. A failure in one is caught by the other three — that overlap is the point.
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Quality system
A GMP plant, organised to ISO 13485
Facility, procedures and people sit under one GMP quality system aligned with ISO 13485 — the same framework our EU notified-body audit measures us against.
ISO 13485Quality management -
Product testing
Endotoxin and residual DNA, held well below the limits
Endotoxin stays under 0.05 EU/mg and residual DNA under 10 pg/µg — the two markers that decide whether a collagen material is safe to place in tissue.
< 0.05 EU/mgEndotoxin · DNA < 10 pg/µg -
Quality control
Purity proven by orthogonal methods
SEC-HPLC for molecular-weight distribution, SDS-PAGE for structural integrity, gas chromatography for residual solvents. Independent methods, so each result can be cross-checked against another.
SEC-HPLC · SDS-PAGEPlus gas chromatography -
Batch traceability
One batch, one electronic record
Every batch carries an electronic record label, so any unit shipped can be traced back through its raw-material lot, its fermentation run and its release tests.
1 batch = 1 recordEnd-to-end trace
Document control
Four tiers of documentation, down to the last wipe.
A quality system is only as good as what it can prove. Ours runs in four tiers — from the manual that sets policy to the form that records a single cleaning step.
- 01
Quality Manual
Quality policy, objectives, organisational structure and responsibilities — the top-level document everything else derives from.
- 02
Procedures
How the system actually runs: deviation handling, change control, CAPA and risk management.
- 03
Work Instructions
The step-by-step layer — equipment operation, cleaning and maintenance, written for the person standing at the machine.
- 04
Records & Forms
Batch production, testing, cleaning and maintenance. Every action leaves a signed, retrievable trace.
Control points
The route a batch travels — and where we stop it.
Six control points from supplier to dispatch. Nothing advances to the next stage until the stage behind it has been signed off.
- 01
Supplier qualification
Incoming materials are only accepted from approved suppliers, and those suppliers are audited as part of our own certification scope.
- 02
Raw material
Identity, purity and bioburden are verified before anything is released to production.
- 03
Fermentation & purification
1,000 L fermentation with automated purification; in-process samples are taken at each step, not only at the end.
- 04
Isolator filling
Aseptic filling inside isolation technology, with environmental monitoring running for the whole fill.
- 05
Batch testing & release
Endotoxin, residual DNA, purity and sterility. A batch is released only against a complete, signed record.
- 06
Warehouse & dispatch
Released stock is held under controlled conditions and shipped with full documentation attached.
The whole system is built to GMP Annex 2 and ICH Q7 for pharmaceutical starting materials — the same reference framework our EU notified body audits against.
Certification
Audited in Europe. Certified in China.
In May 2025 our sterile disposable injection needle and sterile disposable blunt-tip injection needle passed an on-site system audit by the EU notified body UDEM — five days, three sites, four companies.
The audit covered the same product family we ship — one of the reasons the certificate is worth reading rather than framing.
Next step
Ask for the batch record.
Sample requests, OEM programmes and registration documentation — our team answers with the paperwork, not a brochure.