EU 10/2011, EN 1186 & FDA-Aligned Food-Contact Migration Solutions
A Total Migration Tester — also known as an Overall Migration Tester — is a precision analytical instrument that measures the total mass of non-volatile substances that transfer from a food-contact material (plastic film, packaging laminate, container coating, cap liner, sealing gasket) into a food simulant under controlled conditions of time and temperature. Overall migration testing is one of the foundational compliance requirements of every modern food-contact regulation worldwide — EU Regulation 10/2011 (10 mg/dm² overall migration limit), EN 1186 test methods, FDA 21 CFR Part 177, Japanese JFSL, Korean KFDA, and dozens of national standards. Without rigorous migration testing, no plastic packaging material can legally enter food, pharmaceutical, or medical-device service in any major market.
The challenge is that traditional manual migration testing is notoriously labor-intensive: it requires hours of repetitive evaporation, drying, cooling, and constant-weight weighing — each step prone to operator error, atmospheric variation, and weighing inconsistency that can invalidate weeks of work. The Qualitest AUTO QMT™ Series eliminates that challenge. By integrating water-bath evaporation, precise 105 °C chamber heating and drying, cooling functionality, and high-resolution (0.01 mg) constant-temperature weighing into a single fully-automated system, the AUTO QMT platform performs the entire heat-cool-weigh-repeat-to-constant-weight cycle without any manual involvement — delivering the accuracy, repeatability, and regulatory defensibility that modern food-contact compliance programs require.
Qualitest offers three fully-automated platforms covering every throughput requirement: the AUTO QMT-900 is the entry-level standard model for routine pharmaceutical and food-packaging QC operations; the AUTO QMT-1800G is the advanced mid-range platform offering higher throughput and accelerated batch turnaround; and the flagship AUTO QMT-3600 is the highest-capacity model in the lineup, featuring 36 sample stations for maximum-throughput parallel testing in commercial test houses, government inspection bodies, and large multi-line manufacturing operations. All three share Qualitest's premium-engineering foundation: integrated automation, water-bath evaporation, 105 °C drying, 0.01 mg weighing balances, automatic solvent feeding, and the ability to measure not only total migration but also non-volatile matter, evaporation residue, water content, loss on drying (LOD), and total dissolved solids (TDS) in water-quality analysis — making them versatile analytical workhorses far beyond their core migration-testing application.
Applications in Industries
- Food & Beverage Packaging — EU 10/2011 / EN 1186 overall migration compliance testing for flexible films, multi-layer laminates, food trays, beverage containers, coffee capsules, and aseptic packaging.
- Pharmaceutical Packaging — Migration verification of blister-pack films, pre-filled syringes, IV bags, ampoule coatings, primary pharmaceutical packaging, and drug-contact materials per USP, EP, and JP requirements.
- Medical Device Manufacturing — Extractables and leachables screening for medical-grade polymers, implant materials, and sterile-barrier packaging per ISO 10993 and FDA guidance.
- Purified Water & Beverage Production — Total dissolved solids (TDS) analysis, water-quality verification, and packaging-material migration testing for bottled-water and beverage operations.
- Cigarette Tipping Paper & Tobacco Packaging — Migration testing of tipping paper, filter materials, packaging laminates, and other tobacco-product-contact materials.
- Chemical Reagents & Specialty Chemicals — Non-volatile matter, evaporation residue, water content, and loss-on-drying analysis for reagent QC, purity verification, and chemical-product release testing.
- Flexible Packaging Converters — Incoming-material qualification and outgoing-product compliance testing for high-volume converter QC laboratories serving food and pharmaceutical brand owners.
- Third-Party Testing & Inspection Laboratories — Commercial test houses, accredited regulatory laboratories, and customs/border-control inspection bodies running high-throughput migration compliance programs.
- Universities & R&D Laboratories — Food-contact materials research, sustainable-packaging development, novel-polymer characterization, and graduate-level packaging-science training.
Product Comparison Table
Specification | AUTO QMT-900 (Standard) | AUTO QMT-1800G (Advanced) | AUTO QMT-3600 (Highest Capacity) |
Model Tier | Entry-level fully-automatic platform | Mid-range advanced fully-automatic platform | Highest-capacity flagship — 36 sample stations |
Test Process | Fully automatic — no manual involvement | Fully automatic — no manual involvement | Fully automatic — no manual involvement |
Integrated Functions | Water-bath evaporation + heating & drying + cooling + constant-temp weighing | Water-bath evaporation + heating & drying + cooling + constant-temp weighing | Water-bath evaporation + heating & drying + cooling + constant-temp weighing |
Drying Temperature | 105 °C chamber drying after water-bath evaporation | 105 °C chamber drying after water-bath evaporation | 105 °C chamber drying after water-bath evaporation |
Weighing Resolution | Balance resolution 0.01 mg | Balance resolution 0.01 mg | Balance resolution 0.01 mg |
Solvent Feeding | Automatic feeding system with solvent storage tray | Automatic feeding system with solvent storage tray | Automatic feeding system with solvent storage tray |
Test Mode | Heat → cool → weigh → repeat to constant weight | Heat → cool → weigh → repeat to constant weight | Heat → cool → weigh → repeat to constant weight |
Sample Capacity | Standard throughput suitable for routine QC labs | Higher throughput than QMT-900 — accelerated batch testing | 36 sample stations — maximum-throughput, multi-sample parallel testing |
Primary Tests | Total/overall migration, non-volatile matter, evaporation residue, water content, loss on drying, total dissolved solids | Total/overall migration, non-volatile matter, evaporation residue, water content, loss on drying, total dissolved solids | Total/overall migration, non-volatile matter, evaporation residue, water content, loss on drying, total dissolved solids |
Target Industries | Pharma packaging, food packaging, purified water, cigarette tipping paper, chemical reagents | Pharma packaging, food packaging, purified water, cigarette tipping paper, chemical reagents | Pharma packaging, food packaging, purified water, cigarette tipping paper, chemical reagents — high-throughput operations |
Best Suited For | Entry-level food-contact and pharma packaging QC labs needing automated compliance testing | Mid-volume converter and brand-owner labs needing accelerated turnaround with full automation | High-throughput third-party test houses, government inspection bodies, multi-line manufacturing QC |
Why Choose Qualitest for Your Migration Testing Needs
Qualitest is a globally recognized supplier of advanced testing and analytical instruments, serving customers worldwide with one of the most comprehensive Total Migration Tester portfolios available. A real-world case study from Dubai-based Emirates Printing Press (EPP) — a leading provider of tailored packaging solutions — confirmed the Qualitest Total Migration Tester as the ideal solution for testing migration of non-volatile materials in plastic packaging.
Three-Tier Portfolio — One Trusted Source
From the entry-level AUTO QMT-900 standard platform, through the advanced AUTO QMT-1800G for mid-volume operations, to the flagship 36-station AUTO QMT-3600 for the highest-throughput laboratories worldwide — Qualitest offers a coordinated AUTO QMT™ Series that matches every throughput tier, budget, and compliance requirement.
Fully Automated — Zero Manual Involvement
Every AUTO QMT platform performs the complete migration-testing cycle automatically: solvent feeding from the storage tray, water-bath evaporation, 105 °C chamber drying, cooling, and constant-temperature weighing — all without operator intervention. The system repeats the heat-cool-weigh cycle automatically until a stable constant weight is achieved, eliminating the operator-introduced variability that plagues manual migration testing.
0.01 mg High-Resolution Weighing
Every AUTO QMT platform integrates a high-resolution balance with 0.01 mg readability — the analytical sensitivity required to detect migration values well below regulatory limits, deliver defensible compliance data, and support extractables and leachables screening programs in pharmaceutical and medical-device applications.
Versatile Multi-Parameter Capability
Beyond core total/overall migration testing, every AUTO QMT instrument also measures non-volatile matter, evaporation residue, water content, loss on drying (LOD), and total dissolved solids (TDS) in water-quality analysis — making it three or four instruments in one, delivering exceptional value-per-bench-foot of laboratory space.
Regulatory Compliance Built In
Qualitest AUTO QMT platforms are engineered for full compliance with the most demanding global food-contact, pharmaceutical, and packaging regulations — EU 10/2011, EN 1186, FDA 21 CFR Part 177, USP, EP, JP — ensuring every test result is universally accepted, audit-ready, and defensible in customer certifications, regulatory submissions, and EU/FDA inspections.
Cost-Effective Value & Global Support
Qualitest delivers premium migration-testing performance at a transparent, competitive price point — backed by global service, training, IQ/OQ/PQ qualification support, calibration services, and stocked spare parts. Worldwide presence ensures expert installation, operator training, and ongoing service are always within reach, with proven deployments at converter QC operations and contract-packaging facilities.
Migrate Confidence into Every Package
In modern food, pharmaceutical, and medical packaging, the question isn't whether migration is happening — it always is. The question is whether you can prove, in defensible regulatory submissions, that the migration falls below the legal limit. A failed migration test means a recalled product, a blocked customs shipment, a damaged brand, and lost market access. The packaging manufacturers, converters, food and beverage producers, pharmaceutical companies, and contract-packaging operations that consistently launch compliant, durable, market-winning products are the ones equipped with migration testers built for automation, precision, and full international-standards compliance — and the Qualitest AUTO QMT™ portfolio gives you exactly that.
Whether you are qualifying flexible-packaging films for an EU 10/2011 food-contact submission, supporting pharmaceutical-packaging compliance for an FDA Drug Master File, running high-volume converter QC, or commissioning a third-party test house migration program, Qualitest has the AUTO QMT platform engineered to meet your exact needs. From the entry-level AUTO QMT-900 to the flagship 36-station AUTO QMT-3600, every Qualitest migration tester delivers world-class fully-automated performance backed by industry-leading service and support.
