Packaging Engineering & Design
Structural design, material selection, stability testing support, and full packaging validation from early development through commercial launch - aligned with USP, ASTM, and ISTA standards.
OVERVIEW
Effective pharmaceutical packaging starts long before a product reaches the packaging line. The choices made during packaging development - material selection, structural design, closure systems, barrier properties, and distribution packaging configuration - directly determine product stability, patient safety, regulatory compliance, and total cost of ownership throughout the product's commercial lifecycle. Meridan's engineering team partners with pharmaceutical manufacturers from early-stage development through commercial launch and lifecycle management, providing the technical expertise to optimize every aspect of the packaging system.
Our packaging engineers bring deep knowledge of pharmaceutical materials science, container closure system design, regulatory testing requirements, and commercial packaging operations. This combination of development expertise and production experience means our engineering recommendations are not only technically sound but also practically executable on commercial packaging lines. We design packaging that protects the product, meets regulatory requirements, and runs efficiently at scale - reducing development timelines and avoiding costly redesigns during technology transfer and scale-up.
DESIGN
Structural Design
Our structural design services develop complete packaging configurations optimized for product protection, regulatory compliance, and commercial manufacturing efficiency. Starting from the product's physical characteristics, dosage form, and stability profile, our engineers design primary container closure systems, secondary packaging structures, and distribution packaging configurations that work together as an integrated system.
Structural design encompasses blister cavity tooling design, bottle and closure system specification, carton construction and die-line development, and shipper case design. We use CAD modeling and rapid prototyping to evaluate design alternatives before committing to production tooling, reducing development time and cost. Every structural design is evaluated against the packaging line capabilities at our production facilities to ensure seamless technology transfer from engineering to commercial manufacturing without modification.
- ✓Primary container closure system design
- ✓Blister tooling and cavity design
- ✓CAD modeling and rapid prototyping
- ✓Design for manufacturability on commercial lines
MATERIALS
Material Selection
Pharmaceutical packaging material selection requires balancing multiple technical requirements: moisture and oxygen barrier properties, light protection, chemical compatibility, extractable and leachable profiles, mechanical strength, and suitability for commercial packaging processes. Our engineers evaluate materials across all these dimensions to identify the optimal configuration for each product, weighing performance requirements against cost, availability, and sustainability considerations.
We maintain deep expertise in the full range of pharmaceutical packaging materials including PVC, PVDC, Aclar, cold-form aluminum, HDPE, PET, card-dark (Type I, II, and III), elastomeric closures, film laminates, and paper-based materials. For each material option, we provide detailed moisture vapor transmission rate, oxygen transmission rate, and light transmission data to support stability predictions and regulatory submissions. Our material selection process includes supply chain assessment to ensure long-term material availability and multiple sourcing options for critical components.
- ✓Barrier property analysis (MVTR, OTR, light transmission)
- ✓Extractable and leachable assessment support
- ✓Chemical compatibility evaluation
- ✓Supply chain and dual-sourcing assessment
STABILITY
Stability Testing Support
Packaging plays a critical role in product stability, and the container closure system must be demonstrated to maintain product quality throughout its shelf life under defined storage conditions. Meridan's engineering team supports stability testing programs by preparing stability samples in the target packaging configuration, managing sample storage under ICH stability conditions, and coordinating pull schedules with the sponsor's analytical laboratories.
We support both formal ICH stability studies for regulatory submissions and accelerated screening studies used during packaging development to evaluate alternative material and configuration options. Our stability sample preparation processes are documented and controlled within our GMP quality system, ensuring the integrity and traceability of every sample throughout the study duration. We also support container closure integrity testing using vacuum decay, high-voltage leak detection, and dye ingress methods to verify seal performance under stressed conditions.
- ✓ICH stability sample preparation and storage
- ✓Accelerated screening studies for packaging development
- ✓Container closure integrity testing
- ✓Pull schedule coordination with analytical labs
VALIDATION
Packaging Validation (IQ/OQ/PQ)
Packaging validation provides documented evidence that the packaging process consistently produces finished packages that meet all predetermined specifications and quality attributes. Meridan executes comprehensive validation programs following the traditional IQ/OQ/PQ (Installation Qualification, Operational Qualification, Performance Qualification) framework, ensuring every packaging line and process is qualified before commercial production begins.
Our validation engineers develop validation master plans, write and execute qualification protocols, and compile validation reports that support regulatory submissions and inspection readiness. Validation activities include equipment qualification, process validation at target operating parameters, challenge testing at process limits, and ongoing process verification to demonstrate sustained control. We also manage change control processes for validated packaging operations, ensuring that any changes to materials, equipment, or processes are evaluated, documented, and requalified as required.
- ✓IQ/OQ/PQ protocol development and execution
- ✓Validation master plans and summary reports
- ✓Process challenge testing at operating limits
- ✓Change control and requalification management
CHILD RESISTANCE
Child-Resistant Packaging Testing
Products requiring child-resistant packaging must comply with the Poison Prevention Packaging Act and meet the performance requirements specified in 16 CFR 1700.20. Meridan's engineering team supports child-resistant packaging development by designing packaging configurations that meet child-resistance requirements while maintaining senior-friendly accessibility. We evaluate child-resistant closure systems, blister configurations, and unit-dose packaging formats against the applicable performance standards.
Our engineers work with accredited testing laboratories to coordinate child-resistance and senior-friendliness testing, manage test protocols and panel recruitment, and interpret results to guide packaging design decisions. For products requiring compliance with both US (CPSC) and international (ISO 8317) child-resistance standards, we develop packaging configurations that meet both frameworks simultaneously, simplifying global regulatory submissions and reducing the number of unique package configurations required.
- ✓16 CFR 1700.20 child-resistant packaging design
- ✓Senior-friendly accessibility evaluation
- ✓ISO 8317 international CR standard compliance
- ✓Accredited laboratory test coordination
SUSTAINABILITY
Sustainability-Focused Design
Pharmaceutical companies are increasingly focused on reducing the environmental impact of their packaging without compromising product protection or regulatory compliance. Meridan's engineering team supports these sustainability initiatives by evaluating packaging designs for material reduction opportunities, recyclability improvements, and the use of bio-based or recycled-content materials where technically and regulatorily feasible.
Our sustainability-focused engineering services include packaging weight and volume optimization to reduce material usage and transportation impact, evaluation of alternative materials such as fiber-based packaging and mono-material structures that improve recyclability, and life cycle assessment support that quantifies the environmental impact of different packaging options. We balance environmental objectives with the non-negotiable requirements of product stability, patient safety, and regulatory compliance, identifying practical improvements that can be implemented within existing regulatory frameworks.
- ✓Material reduction and weight optimization
- ✓Recyclability and mono-material design evaluation
- ✓Bio-based and recycled-content material assessment
- ✓Life cycle assessment support
STANDARDS
Testing Standards & Capabilities
Our packaging engineering programs are aligned with the industry's most widely referenced testing standards for pharmaceutical packaging. These standards define the test methods, acceptance criteria, and performance requirements that packaging systems must meet for regulatory approval and commercial use. Our engineers maintain current expertise across all relevant standards and coordinate testing with accredited laboratories to ensure results support regulatory submissions worldwide.
Referenced Standards
USP Standards
- USP <671>
Containers - Performance Testing - USP <661>
Plastic Packaging Systems and Their Materials of Construction - USP <1079>
Good Storage and Distribution Practices
Distribution Testing
- ASTM D4169
Standard Practice for Performance Testing of Shipping Containers - ISTA 3A
Packaged Products for Parcel Delivery System Shipment - ASTM D7386
Performance Testing of Packages for Single Parcel Delivery
Engineering Certifications
- •FDA-compliant packaging validation programs
- •USP <671> container performance testing
- •ASTM D4169 distribution testing
- •ISTA 3A certified testing protocols
- •16 CFR 1700 child-resistant packaging compliance
- •ISO 11607 medical device packaging validation
Related Resources
View Case Study: Packaging Redesign for SustainabilityReady to optimize your packaging operations?
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