Audit-ready under cGMP?

Industry

Pharmaceutical glass — regulatory precision, particle inspection, full traceability.

USP Type I/II/III, EP standards, vial and ampoule precision, regulatory traceability.

Hot-end profile

Borosilicate (Type I) for parenterals · soda-lime (Type II/III) for orals · particle/visual inspection at full lot · regulatory audit-ready.

Defects that matter

Glass particles and delamination risk

Dimensional precision for autoinjectors and prefillable syringes

Surface treatment quality

Regulatory non-conformance traceability

Cosmetic defects under MFG visual inspection

Customer & regulatory

USP <660>, <1660>, <87>, <88>, <381> · EP 3.2.1 · ISO 4802 · 21 CFR Part 11 traceability · cGMP compliance.

Customer base

Schott, Gerresheimer, SGD Pharma, Stevanato Group, Nipro, plus pharma OEMs (J&J, Pfizer, Roche, GSK, Novartis, AstraZeneca).

How we apply

Independent audit of IS machines, forehearth, hot-end coating, ware handling and pack-to-melt KPIs.

Section timing, mould equipment, NNPB/BB/PB process control and defect taxonomy linked to root cause.

The world's first systemised Job Change Tool — SKU Library · Live Execution · KPI Tracking.

Live KPI dashboards, hot-end/cold-end data integration, digital audits, real-time defect tracking.

FAQ

Yes. Engagements run with full traceability and align to your QMS.

Bring a problem — leave with a direction.