Alab.Aprotocol.Apapertrail.
Every roll that ships from PharmaFoil carries 47 measured parameters, sampled at six in-process checkpoints, signed off against an ISO 15378 batch record.
3,200 sq.ft. of analytical capacity.
Our independent quality laboratory is segregated from production and equipped with chromatography, spectroscopy and barrier-measurement instrumentation calibrated against NABL-traceable standards.
What we measure, and how.
Six analytical disciplines. One audit trail.
Substrate Inspection
Incoming foil thickness, temper, surface finish and pinhole density per AQL sampling.
WVTR / OTR Testing
Mocon Permatran-W and Ox-Tran systems for moisture and oxygen barrier validation.
Heat Seal Strength
Instron 5944 tensile testing at multiple seal temperatures and dwell times.
Migration Studies
USP <661>, EU 10/2011 and ICH Q3D migration testing in dedicated analytical lab.
Print Adhesion & COF
Tape test, scratch test and coefficient-of-friction measurement on every print run.
Stability Testing
ICH Q1A long-term and accelerated stability chambers at 25°C/60%RH and 40°C/75%RH.
Re-certified continually. Audited annually.
Our quality systems are externally audited every 12 months by TÜV SÜD, BSI and DNV. We host an average of 14 customer audits per year and have never recorded a critical observation in five consecutive audit cycles.
Every batch ships with a Certificate of Analysis, Material Safety Datasheet, batch genealogy and regulatory declaration pack. For US-bound shipments, our DMF Type III (#34218) is referenced under master files for 28 finished-dosage manufacturers.
Ready to qualify a Tier-1 packaging partner?
Share your specifications and we'll respond with a technical quotation, sample reels and a stability protocol in under 72 hours.