Knowledge Base

IVD diagnostic test packaging in a modern clinical laboratory setting
IVD Packaging: Sterile Barrier Requirements and EU IVDR Compliance
Key Takeaways IVD packaging must maintain the defined microbial or sterile state of the product from manufacture to point of use — whether the IVD is a reagent, test strip,... Read more...
Variety of medical packaging materials including Tyvek, foil blisters and PETG trays
Medical Packaging Materials: A Comparative Guide for Sterile Barrier Systems
Key Takeaways Medical packaging materials must satisfy biocompatibility, microbial barrier, sterilization compatibility, and physical performance requirements under ISO 11607-1. No single material meets all application needs — selection requires balancing... Read more...
EU MDR regulatory compliance documentation with medical device packaging
EU MDR Packaging Requirements: Complete Compliance Guide for Manufacturers
Key Takeaways EU MDR 2017/745 Annex I (GSPR 11) requires that sterile medical device packaging maintains its defined microbial state under manufacturer-specified storage and transport conditions. Compliance with EN ISO... Read more...
Sterile blister packaging for medical devices in a clean pharmaceutical environment
Blister Packaging for Medical Devices: Types, Materials, and ISO 11607 Requirements
Key Takeaways Blister packaging for medical devices falls into two main categories: thermoformed rigid blisters and cold-form foil blisters, each suited to different device types and sterilization methods. ISO 11607-1... Read more...
Medical device packaging accelerated aging study in laboratory oven
Accelerated Aging Testing for Medical Device Packaging: ASTM F1980 Guide
14 min read
STANDARDSTESTING
Key Takeaways ASTM F1980 is the standard guide for accelerated aging of sterile barrier systems, enabling manufacturers to generate shelf life data without waiting for real-time studies to complete. The... Read more...
Tyvek medical packaging heat sealing in sterile manufacturing environment
Tyvek Medical Packaging: Materials, Grades, and Sterilization Compatibility
13 min read
MATERIALS
Key Takeaways DuPont Tyvek is a high-density polyethylene (HDPE) nonwoven material that is the dominant substrate for porous medical device packaging worldwide. Three primary Tyvek grades serve medical packaging applications:... Read more...
Medical packaging laboratory with sterile Tyvek pouches
ISO 11607 Explained: Complete Guide to Medical Device Packaging Compliance
11 min read
REGULATIONSSTANDARDS
Key Takeaways ISO 11607 is the globally harmonized standard for packaging terminally sterilized medical devices, covering both materials (Part 1) and process validation (Part 2). Compliance with ISO 11607 satisfies... Read more...
Seal integrity inspection of sterile medical device pouches in cleanroom
Seal Integrity Testing for Sterile Medical Packaging: Methods and Best Practices
15 min read
TESTING
Key Takeaways Seal integrity testing verifies that the seals of a sterile barrier system are free of defects that could allow microbial ingress, and is a mandatory element of ISO... Read more...