Pharmaceutical Packaging Testing
Pharmaceutical Packaging Requirements
A pharmaceutical product is only as well protected as its packaging, and regulators require proof of that before it reaches the market. FDA submissions require validated records covering shelf life, seal integrity, and packaging performance. Controlled substance packaging adds another layer: federal law requires testing at a DEA-registered facility.
Packaging Testing & Validation Services
Pharmaceutical Package Testing
Accelerated aging, sterile barrier validation, conditioning, and controlled substance packaging testing for FDA-regulated pharmaceutical packaging, under DEA Controlled Substance Registration and ANAB ISO/IEC 17025 accreditation.
Environmental Package Testing
Accelerated aging and conditioning testing for pharmaceutical shelf life validation programs, supporting expiration date claims and FDA documentation requirements.
Most labs can't touch controlled substance packaging
What We Test for Pharmaceutical Companies
Climatic stressing for distribution qualification
Pharmaceutical packaging that ships via parcel delivery must demonstrate performance through temperature and humidity variation in the distribution environment.
Sterile barrier systems for pharmaceutical products
ISO 11607 requires that packaging for terminally sterilized pharmaceutical products be validated
Applicable Standards and Methods
Packaging conditioning before performance testing
Pre-test conditioning establishes consistent material properties across pharmaceutical packaging validation programs, required in most FDA-aligned packaging validation protocols.
Applicable Standards and Methods
Accelerated aging for shelf life validation
FDA and ICH Q1A guidelines require documented evidence that packaging maintains performance through the claimed shelf life. Accelerated aging compresses the real-time aging period into a validated test program.
Controlled substance packaging qualification
Federal law requires that packaging testing for Schedule I through V controlled substances be conducted at a DEA-registered facility.
Cold chain packaging for temperature-sensitive products
Biologics, vaccines, and other temperature-sensitive pharmaceutical products require insulated shipper validation confirming payload temperature is maintained through the distribution environment.
Applicable Standards and Methods
Accreditations That Apply
Our accreditations determine which standards we test to, which regulatory submissions our results support, and which retailer programs our clients can qualify for.
Our Accreditations
ANAB ISO/IEC 17025 Accreditation
DEA Controlled Substance Registration
Frequently Asked Questions
DEA Controlled Substance Registration is a federal requirement for any laboratory that handles or tests packaging associated with Schedule I through V controlled substances. Pharmaceutical companies packaging controlled substances must complete packaging qualification at a DEA-registered facility, as the registration is what gives the testing record its compliance standing. TEN-E’s active registration covers the full Schedule I through V range and is held alongside ANAB ISO/IEC 17025 accreditation, so controlled substance packaging testing and broader pharmaceutical packaging validation programs can be completed in the same accredited lab.
The test methods and applicable standards overlap substantially: both categories use ISO 11607, ASTM F1980, and conditioning standards. The regulatory context differs: medical device packaging falls under 21 CFR Part 820 and related FDA quality system requirements, while pharmaceutical packaging falls under FDA pharmaceutical regulations and ICH guidance. The additional layer for pharmaceutical companies is DEA registration for controlled substance packaging. TEN-E holds both ANAB ISO/IEC 17025 accreditation and DEA registration, covering the full compliance requirement set for pharmaceutical packaging validation programs.
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