Ever since the beginning of terminally sterilized medical device packaging—AWT has led the medical products labels and packaging industry. Expert advice and reliable processes ensure medical products hit the receiving dock in a safe, timely and compliant manner.
Tamper Evident Labels and Packaging: AWT created the first tamper evident label ever used on a medical device. This groundbreaking innovation has become the staple of terminally sterilized medical device packaging and adopted in across a broad array of other packages. Ease of use, while maintaining security, is a key element in all of our tamper evident closure labels.
Terminally Sterilized Labels and Packaging: A sterile barrier package must be qualified, validated, produced and sealed consistently every single time. It also needs to be properly labeled, an aspect of medical products manufacturing that attracts more than its share of FDA scrutiny. We’ve been producing labels and Tyvek® lidding that meets these standards for almost 40 years.
Qualified and Validated Quality System: AWT uses a robust ISO 9001 certified quality system. Documented systems, traceability, and change control are the tools our experienced team uses to ensure the highest level of quality—a documented rate higher than 99%.
Validation and Qualification Expertise: For labeling changes and upgrades, our clients work directly with the R&D department at AWT. We develop options and prototypes – and our internal test lab will even conduct some of the validation testing. We know protocols that your Regulatory Affairs and Quality Departments demand and have the expertise and facilities to support you through this process.
Supplier Managed Inventory (SMI) Programs: Our skilled account management teams are trained to manage our customer’s inventory like an extension of their supply chain. We are flexible to implement SMI with customers or interface with our customer’s legacy inventory systems and operate min/max, Kanban, Hold and release programs.
Dock to Stock Certified: Some of our medical customers have qualified AWT’s label parts to bypass their incoming/receiving inspection step and proceed directly to label storage. Our medical customers tell us this saves significant time and cost!
Unique Device Identifier (UDI): Unique Device Identifier (UDI): The final rule was passed after a long, rigorous review in September of 2013. The rule requires medical devices and device packages to have a product identifier on the units with specific production information. For a more detailed synopsis of the new ruling, please check out the FDA Guidance Document.