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Packaging and simulated distribution testing

Demonstrate packaging performance to protect medical device, drug product, and consumer goods integrity. Container Closure Integrity (CCIT) testing, container qualification, and simulated distribution testing services are designed to mitigate transit risk, support compliance and ensure safe delivery to end users.

Packaging and simulated distribution testing

Confidence from pack to patient

Packaging plays a critical role in protecting product quality throughout storage, transport, and delivery. Our packaging and distribution testing services help you verify that your packaging systems can withstand real-world hazards without compromising product integrity or patient safety.

Our experienced teams work with you to evaluate packaging performance against drops, vibration, compression, altitude-pressure, temperature changes, freeze-thaw cycles, and other common distribution stresses. By combining standardized test methods with custom study design, we help identify vulnerabilities, optimize packaging configurations, and demonstrate compliance with industry and regulatory expectations.

Our packaging and distribution services include:

Simulated distribution testing: Evaluation of packaged products using ASTM, IEC, and ISTA methods to replicate real-world transport and handling conditions.
Packaging system qualification: Verification that packaging configurations protect product integrity throughout storage, distribution, and in-use.
Cold chain container qualification: Testing and validation of passive and active thermal containers for temperature-sensitive products.
Process optimization support: Identification of packaging failure points and validation of production parameters across packaging components.
Regulatory and standards compliance: Testing aligned with ISO 11607 and other applicable packaging and distribution standards.
Functional performance assessment: Evaluation of product functionality following exposure to physical and environmental transit hazards.

Specialized package performance testing

Our flexible, collaborative approach allows us to tailor testing programs to your product, packaging design, and supply chain.

Component Quality Testing

Our services range from feasibility assessments to full method optimization and validation programs to stability program storage and routine testing.

Test method references include:

USP Packaging Component Quality Tests
USP <660>, Pharmaceutical Glass Testing,
USP <661> / <662>, Plastic Container Testing,
USP <670>, Auxiliary Packaging Components
USP <671> Containers – Performance Testing
Moisture Vapor Transmission Rate (MVTR)
Oxygen Transmission (OTR)
Spectral Transmission
Classification Study

Package Label Testing

Assessment of label legibility, adhesion, and durability through temperature and humidity exposure, peel resistance and abrasion testing to support compliance and end-user safety.

Test method references include:

ASTM D6252, Peel Adhesion of Pressure-Sensitive Label Stocks at a 90° Angle
ASTM D6862, 90 Degree Peel Resistance of Adhesives
ASTM D3330, Peel Adhesion of Pressure-Sensitive Tape
ASTM D2979, Pressure-Sensitive Tack of Adhesives Using an Inverted Probe Machine
ASTM D6195, Loop Tack
FINAT Methods #1 – #9
ASTM D5264, Abrasion Resistance of Printed Materials by the Sutherland Rub Tester
PSTC Methods
Attribute Inspections over Time

Package Strength Testing

Characterize and monitor package seal quality to monitoring the consistency over time despite pressure differentials or physical defects. Evaluating package strength ensures a robust barrier against contamination and damage through the product lifecycle.

Test method references include:

ASTM F88 – Seal Strength of Flexible Barrier Materials
ASTM F1140 – Internal Pressurization Failure Resistance of Unrestrained Packages
ASTM F1886 – Integrity of Primary Packaging by Visual Inspection
ASTM F2054 – Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates
ASTM F2096 – Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
ASTM D3078 – Determination of Leaks in Flexible Packaging by Bubble Emission

Package Material Testing

The physical, and sometimes chemical, properties of the packaging materials are critical to informing the design process. We offer a wide variety of testing options when it comes to testing packaging materials, such as material qualification and identification, or characterizing material response to fatigue. We evaluate flexure, compression, tensile, puncture and impact, dye ingress, and abrasion performance.

Test method references include:

ASTM D780 – Printing Ink Permeation of Paper
ASTM F392 – Conditioning Flexible Barrier Materials for Flex Durability
ASTM D882 – Tensile Properties of Thin Plastic Sheeting
ISO 527 – Determination of tensile properties
ASTM F1306 – Slow Rate Penetration Resistance of Flexible Barrier Films and Laminates
ASTM D3420 – Pendulum Impact Resistance of Plastic Film
USP <381> Elastomeric Components in Injectable Pharmaceutical Product Packaging/Delivery Systems
ISO 11040 – Prefilled syringes
ASTM D1876 – Peel Resistance of Adhesives (T-Peel Test)
ASTM D6862 – 90 Degree Peel Resistance of Adhesives
ASTM D3330 – Peel Adhesion of Pressure-Sensitive Tape
ASTM D903 – Peel or Stripping Strength of Adhesive Bonds
ASTM D5264 – Abrasion Resistance of Printed Materials by the Sutherland Rub Tester

Package Integrity Testing

For medical devices, package integrity pertains to testing sterile barrier packaging (SBS). Similarly, drug products prioritize parenteral packaging integrity to maintain a sterile product closure system by keeping detrimental environmental contaminants out. Such contaminants may include microorganisms, reactive gases, and other substances. The product includes the pharmaceutical formulation as well as the package headspace – which may consist of ambient air or nonreactive gases with a specified water-vapor content, under full or sub atmospheric pressure levels.

Test method references include:

ISO 11607 Packaging for terminally sterilized medical devices
USP <1207> Package Integrity Evaluation – Sterile Products
ASTM D3078 Determination of Leaks in Flexible Packaging by Bubble Emission
ASTM F2096 Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
ASTM F1929 Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
ASTM F3039 Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration
ASTM D4991 Leakage Testing of Empty Rigid Containers by Vacuum Method
ASTM D6653 Determining the Effects of High Altitude on Packaging Systems by Vacuum Method
ASTM D2063 Measurement of Torque Retention for Packages with Continuous Thread Closures Using Non-Automated (Manual) Torque Testing Equipment

Custom Packaging Solutions

Development of tailored testing strategies to support new packaging configurations, international shipment requirements and evolving supply chain challenges, delivered with expert guidance across all project phases.

Key Considerations for End-to-End Primary Packaging Solutions for Pharmaceuticals & Medical Devices

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Parenteral Product Packaging and Delivery Systems

USP <382> guidance took effect on December 1, 2025, with new regulatory requirements for parenteral product packaging and delivery systems. This standard establishes responsibility for maintaining package integrity to finished product manufacturers and requires thorough risk assessment and the use of deterministic testing methods.

Our experts offer reliable guidance and testing services to achieve compliance at any stage of the product lifecycle, including new product development, packaging changes, line extensions, and remediation studies. Compared to USP <381> standards, testing must now evaluate the entire packaging system holistically rather than just the individual components.

Trust our team to evaluate your parenteral drug product packaging and delivery systems to comply with USP <382> and other key distribution standards. When compared to USP <381> standards, USP <382> now requires testing to evaluate the entire packaging system holistically rather package components evaluated individually.

Component Quality Testing

Employ our container closure integrity (CCI) testing programs to provide accurate, sensitive, and reliable data regarding your product packaging performance. We help maintain sterile packages by evaluating system integrity with deterministic test methods outlined in USP <1207> guidance.

This information enables you to characterize packages and materials, optimize sealing parameters, evaluate package storage temperature impact, replace sterility tests for product stability batches, screen production lots for faulty packages, and support regulatory submission applications.

We offer numerous sophisticated programs for assessing package system integrity, including all crucial instrumentation for deterministic test methods as outlined in the United States Pharmacopoeia:

High Voltage Leak Detection (HVLD)
Laser Based Headspace Analysis (HSA)
Vacuum Decay Leak Detection
Tracer Gas (Helium) Leak Detection (HeLD)

Container Closure Integrity (CCI) Testing

Employ our container closure integrity (CCI) testing programs to provide accurate, sensitive, and reliable data regarding your product packaging performance. We help maintain sterile packages by evaluating system integrity with deterministic test methods outlined in USP <1207> guidance.

This information enables you to characterize packages and materials, optimize sealing parameters, evaluate package storage temperature impact, replace sterility tests for product stability batches, screen production lots for faulty packages, and support regulatory submission applications.

We offer numerous sophisticated programs for assessing package system integrity, including all crucial instrumentation for deterministic test methods as outlined in the United States Pharmacopoeia:

High Voltage Leak Detection (HVLD)
Laser Based Headspace Analysis (HSA)
Vacuum Decay Leak Detection
Tracer Gas (Helium) Leak Detection (HeLD)

Secure Data Accessibility

PacePort is our secure client data access portal; a web-based data delivery system that allows you to access to methods, specifications, reports, and other information at any time, from any location. The materials available via PacePort are of sufficient quality to be used during audits.

Portal access

Analytical testing to help you move forward and stay ahead

Raw Materials

ICH Stability Storage Services

ICH Stability Storage Services

Microbiology Testing

Microbiology Testing

Extractables and Leachables Testing

Extractables and Leachables Testing

Impurities Testing

Impurities Testing

Reference Standards

Reference Standards

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