Business Details
Expert Package Engineering Services for Medical Devices
PackWise Consulting specializes in package engineering for sterile medical devices, offering tailored solutions to meet global regulatory standards. With over 30 years of experience in packaging design, validation, and optimization, we provide unbiased expertise for projects ranging from material testing to cold chain shipping. Our founder, Jan Gates, has led industry task groups and collaborated with major medical device companies to develop compliance frameworks. We prioritize sterile barrier integrity, sustainable packaging strategies, and distribution testing to ensure product safety. Our services align with ISO 11607, ASTM D10, and ISTA standards, supporting clients through every phase of packaging development.By combining technical rigor with practical problem-solving, we deliver solutions that enhance efficiency and regulatory compliance. Our work extends to pharmaceuticals, diagnostics, and combination products, reflecting a deep understanding of complex packaging challenges. Clients benefit from our hands-on approach to validation master planning and equipment qualification. We maintain active memberships in leading industry organizations to stay at the forefront of packaging innovation. Whether addressing accelerated aging studies or sustainable material selection, our focus remains on ensuring sterile medical device packaging meets both regulatory and operational demands.
Services
Sterile Barrier Engineering
Packaging Validation
Cold Chain Shipping
Material Testing
Sustainability Consulting
Distribution Testing
Equipment Validation
Highlights and features
- We offer 30+ years of specialized experience in sterile medical device packaging engineering
- Our team led ISO 11607 compliance frameworks adopted as industry standards
- We provide hands-on validation master planning for complex packaging systems
- Our expertise spans FDA, EU, and Japanese regulatory requirements for medical devices
- We maintain active leadership roles in ASTM D10 and IoPP packaging standards committees
Associations and certifications
- ASTM International
- ISO (International Organization for Standardization)
- ISTA (International Safe Transit Association)
Services
Sterile Barrier Engineering
Design and validation of sterile barrier systems compliant with ISO 11607 standards. Our engineering services ensure medical device packaging maintains sterility throughout distribution and storage. We conduct comprehensive testing for seal integrity, material compatibility, and sterilization method validation.
Packaging Validation
Comprehensive validation master planning for medical device packaging systems. Our services include protocol development, accelerated aging studies, and distribution simulation testing to meet FDA and EU regulatory requirements. We ensure packaging performance under real-world conditions.
Cold Chain Shipping
Specialized packaging solutions for temperature-sensitive medical devices. We develop validated cold chain shipping systems that maintain required temperature ranges during global distribution. Our services include thermal mapping and environmental stress testing.
Material Testing
Comprehensive evaluation of packaging materials for medical devices. Our testing services assess physical properties, chemical resistance, and compatibility with sterilization methods. We provide failure analysis and material selection guidance for optimal performance.
Sustainability Consulting
Strategic consulting for sustainable medical device packaging. We help clients reduce environmental impact while maintaining compliance through material optimization, waste reduction strategies, and eco-friendly packaging design.
People
Jan Gates
Founder
30+ years of package engineering experience across medical devices, pharmaceuticals, and consumer goods. Led ISO 11607 compliance initiatives and served as task group leader for AAMI TIR 22. Holds extensive expertise in sterile barrier systems and regulatory compliance.
Questions
What packaging validation services do you offer for medical devices?
We provide comprehensive validation services including protocol development, accelerated aging studies, and distribution simulation testing to meet FDA, EU, and ISO 11607 requirements.
How do you ensure sterile barrier system integrity?
We conduct seal integrity testing, material compatibility assessments, and sterilization validation using industry-standard methods to guarantee sterile barrier performance throughout product lifecycle.
Can you help with cold chain packaging requirements?
Yes, we develop validated temperature-controlled packaging systems and perform thermal mapping to ensure medical device stability during global cold chain distribution.
What sustainability solutions do you provide for medical packaging?
We offer material optimization strategies, waste reduction programs, and eco-friendly packaging design solutions that maintain regulatory compliance while minimizing environmental impact.
How do you handle international regulatory requirements?
Our team has extensive experience with FDA, EU MDR, and Japanese regulatory frameworks, ensuring packaging solutions meet global compliance standards for medical devices.
What is your approach to packaging material testing?
We perform physical property analysis, chemical resistance testing, and compatibility assessments with sterilization methods to ensure optimal material performance for medical device packaging.
