Specialist Investigations

Packaging & Contact Materials Testing

Extractables, leachables, container closure integrity and product compatibility for pharmaceutical, nutraceutical and food packaging. We help you prove that what protects the product does not contaminate it.

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What It Covers

Scope of Work

Extractables screening on candidate primary packaging

Leachables study design, execution and toxicological liaison

Container closure integrity (CCI) by dye ingress, vacuum decay or He-leak (referral)

Moisture-vapour transmission rate (MVTR) and oxygen transmission rate (OTR)

Product / packaging compatibility studies

Migration testing for food-contact materials

Cap-torque, child-resistance and tamper-evidence (referral)

Stability of packaged product across packaging variants

How We Do It

Methods & Instrumentation

LC-MS / LC-MS/MS

Extractables / leachables identification and quantification.

GC-MS / Headspace

Volatile and semi-volatile extractables profiling.

ICP-MS

Elemental leachables and trace metal extractables.

HPLC / UPLC

Quantitative leachables monitoring during stability.

MVTR / OTR

Permeation testing per ASTM and ISO methods.

Dye Ingress / Vacuum Decay

Container closure integrity verification.

Regulatory Framework

Standards This Work Maps Onto

Methods, documentation and acceptance criteria are designed to align with the standards below. This describes design intent — formal accreditations are listed on the About page.

USP <1663> — Assessment of Extractables

USP <1664> — Assessment of Drug-Product Leachables

USP <661>, <671> — Containers

EU Regulation 10/2011 — Plastic Food-Contact Materials

ICH Q3E — Extractables and Leachables (final / draft per region)

PQRI recommendations for OINDP / PODP

What You Receive

Typical Deliverables

Extractables study protocol and report

Leachables study protocol, execution and final report

CCI test report with acceptance criteria

MVTR / OTR test report per packaging variant

Migration testing report for food-contact components

Risk assessment linking extractables to leachables

Who It's For

Sectors We Support

Pharmaceutical drug-product manufacturers

Inhalation, ophthalmic and parenteral product owners

Consumer healthcare brands launching new pack formats

Food and beverage manufacturers using novel packaging

Packaging suppliers needing customer-facing data

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