What Is Pharmaceutical Package Testing?
Pharmaceutical package testing validates that packaging maintains product integrity through manufacturing, distribution, and the product’s intended shelf life. Testing covers two primary areas: performance validation for sterile pharmaceutical packaging, which follows the same sterile barrier requirements as medical device packaging under ISO 11607, and packaging qualification for products that require DEA-registered testing facilities because the product is a controlled substance.
For sterile pharmaceutical packaging, testing confirms that the sterile barrier survives distribution and storage conditions and that accelerated aging data supports the product’s labeled shelf life. For controlled substance packaging, DEA registration is a compliance requirement for the testing facility: only DEA-registered labs may handle or test packaging associated with Schedule I through V substances.
Why Does Pharmaceutical Package Testing Matter?
FDA requirements for pharmaceutical packaging are defined across multiple regulations and guidance documents. Sterile pharmaceutical products require packaging validated under ISO 11607. Shelf life labeling requires documented accelerated aging data. Distribution performance must be validated for packaging that moves through supply chains before reaching pharmacies, hospitals, or patients.
For pharmaceutical companies packaging controlled substances, the compliance requirement extends to the testing lab itself. Testing packaging for a Schedule I through V controlled substance at a facility without DEA registration is a federal compliance violation. TEN-E’s active DEA Controlled Substance Registration covers the full range of controlled substance schedules and is one of the credentials that gives TEN-E’s pharmaceutical testing scope its practical depth for this segment.
Who Is Pharmaceutical Package Testing For?
Pharmaceutical
Pharmaceutical manufacturers validate packaging for shelf life, sterile barrier integrity, and controlled substance handling at a DEA-registered lab.
Accreditations That Apply
Every pharmaceutical testing program is built from recognized procedures, run on calibrated equipment, and backed by laboratory accreditation and federal registration.
Our Accreditations
ANAB ISO/IEC 17025 Accreditation
DEA Controlled Substance Registration
Pharmaceutical Testing Methods & Standards
Testing Methods
Frequently Asked Questions
DEA Controlled Substance Registration authorizes TEN-E to handle and test packaging associated with Schedule I through V controlled substances. For pharmaceutical companies packaging controlled substances, federal law requires that testing be performed at a DEA-registered facility. Sending controlled substance packaging to a lab without DEA registration creates a compliance gap in the packaging qualification record. TEN-E’s active DEA registration covers the full Schedule I through V range, which means pharmaceutical clients can complete controlled substance packaging qualification at the same accredited lab where they conduct accelerated aging, conditioning, and performance testing.
The testing methods and applicable standards overlap substantially. Both pharmaceutical sterile packaging and medical device sterile packaging are validated under ISO 11607 and use accelerated aging (ASTM F1980), seal strength testing, and conditioning protocols. The primary distinction is regulatory context: medical device packaging is governed by FDA’s 21 CFR Part 820 and related quality system requirements, while pharmaceutical packaging falls under FDA’s pharmaceutical regulations and guidance documents. For pharmaceutical products that are also classified as controlled substances, the additional compliance layer is DEA registration at the testing facility. TEN-E holds both ANAB ISO/IEC 17025 accreditation and DEA registration, covering the full requirement set for pharmaceutical packaging validation.
Yes. Many pharmaceutical packaging validation programs require both sterile barrier testing and distribution performance testing. TEN-E tests pharmaceutical packaging to ASTM F2825 for climatic stressing through parcel delivery conditions and can sequence distribution performance testing after conditioning or accelerated aging within a single lab program. Combined testing at a single accredited facility maintains sample chain of custody and simplifies the validation documentation record.
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