Packaging & Container-Closure E&L — Pharma and Device Study Design

Pharmaceutical container-closure and delivery systems can leach compounds into a drug product over its shelf life. E&L programmes for packaging follow the product's dosage form, contact conditions and the applicable compendial and PQRI-informed expectations — not a device template.

Match the study to the dosage form

Inhalation, injectable, ophthalmic and oral products carry different risk and different expectations for extraction and simulation studies. Define the container-closure system components — glass, elastomers, polymers, adhesives, inks and labels — and the formulation's composition, pH and co-solvents. Simulation under actual storage conditions and leachables surveillance over shelf life answer different questions than a one-time exaggerated extraction.

Set the analytical evaluation threshold with the product in mind

Thresholds depend on daily dose and route. Agree the AET basis, identification and quantitation strategy, and how elemental impurities are handled alongside organic leachables. A screening method validated for one matrix may not transfer directly to a complex formulation; ask how matrix effects and method suitability are demonstrated.

Plan lifecycle and change control

Supplier changes, resin or elastomer changes and new manufacturing sites can require comparative or repeat work. Agree how the laboratory documents system suitability, mass balance and trend data so a change assessment can rely on earlier studies. The data support the marketing authorization holder's assessment; they do not replace it.

Extractables, leachables and product context

Extractables describe constituents released under defined laboratory extraction conditions; leachables concern release under actual or justified simulated use. Start with composition, polymers, additives, adhesives, coatings, processing aids and manufacturing/sterilization residues. Device patient exposure differs from drug-container interactions and pharmaceutical stability programmes. Combination products need coordinated device and drug evidence—not an unqualified device protocol applied to every container.

Distinguish final guidance from draft recommendations

FDA's September 2024 chemical-analysis guidance is draft — not for implementation; it is not final guidance or mandatory law. FDA's September 2023 risk-based biological-evaluation guidance remains final. Agree the applicable evidence strategy rather than treating draft chemistry recommendations as a universal test requirement.

What to include in your buyer brief

Start with the decision the work must support. Unknown details can be clarified after the initial inquiry.

Product, materials/formulation, patient or drug contact, contact duration, intended use and target market; identify changed materials, suppliers or processes.
Finished configuration, sample count and lots, sterilization modality/cycles, aging and storage history; justify worst-case variants and destructive allocations.
Existing evaluation plan, drawings, specifications, methods/editions, previous reports and acceptance criteria; send confidential files only through the private intake.
Required report, quality/accreditation scope, budget range, location, shipping constraints and decision deadline; ask the provider to explain exclusions and subcontracted work.

Sample considerations

Provide container-closure component specifications, suppliers and material disclosures.
Describe the drug product: dosage form, formulation, fill volume, storage conditions and shelf life.
Agree extraction and simulation designs, thresholds, time points and retained samples.

Questions to ask a laboratory

How is the AET derived for our dose and route?
Which compendial and PQRI-informed expectations frame the study design?
How will supplier or material changes be bridged to the existing dataset?

Laboratories with relevant capabilities

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Frequently asked questions

What makes an E&L study defensible?: A documented rationale for study design, appropriate analytical coverage, and a toxicological assessment of what was found.