การตรวจสอบบรรจุภัณฑ์ทางการแพทย์ที่ปลอดเชื้อ Sterile Medical Package Inspection

การผลิตอุปกรณ์ทางการแพทย์มีข้อกำหนดและคุณสมบัติเฉพาะของบรรจุภัณฑ์ ที่ต้องการแนวทางครอบคลุมในการเลือกวิธีการตรวจสอบที่ถูกต้อง ละเอียด และแม่นยำ มีวิธีการตรวจสอบที่หลากหลายสำหรับการตรวจสอบบรรจุภัณฑ์ทางการแพทย์ที่ปลอดเชื้อ Sterile Medical Package Inspection ที่ต้องการความเข้าใจอย่างละเอียดเพื่อให้มั่นใจในคุณภาพ

ไม่แปลกที่บริษัทยาและอุปกรณ์การแพทย์หลายแห่ง เพิ่มความเข้มงวดในการทดสอบบรรจุภัณฑ์ โดยเฉพาะบรรจุภัณฑ์ปลอดเชื้อ Sterile Medical Package Inspection และปรับปรุงวิธีการทดสอบเพื่อเพิ่มความมั่นใจต่อผลการทดสอบ และเมื่อต้องชั่งใจระหว่างความผิดพลาดที่เกิดจากคนเทียบกับเครื่องจักร และปริมาณของเสียจากการทดสอบ เราจึงได้ยินศัพท์ Container Closure Integrity Testing (CCIT) และ Non-Destructive Testing (NDT) / Non-Invasive Testing (NIT) กันบ่อยขึ้น จนกลายเป็นแนวทางในการทดสอบความสมบูรณ์ของบรรจุภัณฑ์ของผลิตภัณฑ์ปลอดเชื้อของ USP Chapter 1207 ไปแล้ว

Sterile Medical Package Inspection

Introduction
Class III medical devices have a unique set of requirements and package characteristics that need a comprehensive approach to selecting the right inspection methods. A variety of inspection methods exist for medical package inspection that require a thorough understanding to ensure quality.

The predominant inspection method for medical device packaging has been manual visual inspection. While this approach is covered by an ASTM method (ASTM F1886), it may not be appropriate for certain applications and is limited in capability. Manual visual inspection has the capability to detect a 75-micron channel defect, but even the ASTM method F1886 outlines that the probability of detection ranges from 60% to 100%. This wide range of uncertainty does not provide the confidence needed for higher risk medical device packaging.

An operator’s ability to detect defects diminishes as the time spent inspecting packaging increases. Manual visual inspection effectiveness is also dependent on the package materials, lighting and the scope of inspection. Non-transparent and foil-barrier pouch formats are excluded from manual visual inspection as an option. Sandia National Laboratories produced the report

“Visual Inspection: a Review of Literature”, which outlines in detail the challenges associated with visual inspection. When inspecting for seal quality and package integrity there are better alternatives.

Some offline leak detection methods can provide a quantitative assessment of seal quality, but they neglect to capture some of the most common seal defects with Class III medical packaging. Random seal defects will not be identified by testing peel strength or using other destructive approaches. The use of online non-destructive inspection methods is ideal for class III products, providing the ability to control quality with complete production lot data.

Defining Scope
Product sterility is a common thread between all Class III medical devices, but package materials and design vary greatly. Inspecting a porous pouch or tray requires a completely different approach than a format that is non-porous. Tyvek® provides a sterile barrier and the material porosity limits available leak test methods to test the package body. In the case of porous packaging the focus for online inspection shifts from leak detection to evaluating seal quality.

Ahead of pursuing any inspection solution it is critical to understand the primary scope of the inspection. What are the most common defects produced in manufacturing? What are the risks associated with those defects? An analysis of FDA warning letters and recalls shows that the vast majority of issues are related seal defects attributed to both process and personnel error. While micro leaks pose a risk, the majority of defects are larger seal related quality deviations. Avoid losing a view of the bigger picture by focusing on quality outliers.

Ask fundamental questions at the core of package inspection:

> What are the materials used? Is it flexible, semi-flexible or rigid? Porous or non-porous?
> Is it a dual barrier system? Are sterile barrier requirements the same for both barriers?
> What are the product requirements? Sterility requirements?
> What seals are being created in the process? Any specific risks associated with that process? Any specific requirements of those seals?
> What needs to be inspected?
> Is there a requirement for 100% inspection? What is the production throughput?

The Six-Sigma curriculum focuses on DMAIC (Define, Measure, Analyze, Improve, Control). If the quality related issues cannot be properly defined, achieving the final stage of control will be fleeting. Define the target with respect to the primary quality related issues and introduce an effective method to measure against those attributes. The first two steps, define and measure, are vital to success of any quality assurance plan.

Technology Overview
An ideal test method must meet two fundamental criteria. The method must be capable of measuring or detecting the quality attribute, and the method must be reliable. If a test method is not reliable it is at the very least a headache, and in many cases the primary source for your quality woes.

PTI offers two primary technologies to inspect medical device packaging; vacuum decay and airborne ultrasound. Both technologies aim to offer quantitative and deterministic test results to evaluate the package quality. The two technologies are vastly different in function and performance. Vacuum decay is focused on package integrity and detection of leak paths. Airborne ultrasound is focused on seal inspection and seal quality. Some package applications can be addressed with both technologies while other package inspection applications only have a singular solution. Both technologies aim to provide the fundamental requirements of being reliable and sensitive inspection methods for Class III medical device applications.

Vacuum Decay (ASTM F2338)
PTI’s VeriPac leak testers connect to a test chamber that is specially designed to contain the package to be tested. When testing pouches a flexible adaptable test chamber can be used universally across different pouch sizes. The package is placed inside the test chamber to which vacuum is applied. During the short test cycle both the level of vacuum as well as the change in vacuum over a predetermined test time is measured. The changes in vacuum level indicate the presence of leaks and defects within the package.

The sensitivity and reliability of a vacuum decay test method makes it a go-to standard for sterile products. Test systems can be designed for manual or automatic operation, making the method suitable for laboratory offline testing and production applications for quality assurance process control.

PTI’s technology was used to develop the ASTM vacuum decay leak test method (F2338) recognized by the FDA as a consensus standard for package integrity testing. Vacuum decay is referenced in ISO 11607 and the new USP 1207 guidance document as a deterministic test method for package integrity testing.

Airborne Ultrasound (ASTM F3004)
PTI’s Seal-Scan® and Seal-Sensor® are non-contact airborne ultrasonic testing technologies. To use ultrasonic inspection effectively, it must be possible to move the seal through the direct point of focus within the inspection head along the direction of the seal. The technology can operate at a line speed of 40 cm/sec keeping up with typical pouch line operations.

Similar to the principles of how a double-pained glass window blocks sound, a good seal will transmit sound between the transducers while a defect disrupts the signal with the multiple unbonded layers. Channel defects, inclusions, wrinkles and weak seals also affect the signal transmission through the seal and are detectable. Various types of defects, visible and invisible, leaking and non-leaking, process-related and random, are detectable.

Ultrasound technology is an ASTM Test Method F3004-13 and is also referenced in in ISO 11607 and the new USP 1207 guidance document. Airborne ultrasound technology has been established as one of the most effective methods for non-destructive testing of flexible packaging. The leaking nature of porous packaging introduces a unique challenge to most inspection methods, and airborne ultrasound effectively resolves those challenges with its non-destructive measure of seal quality.
Inspecting the integrity of class III medical device packaging is diverse in the array of package types and materials. The critical requirements associated with sterile packaging raises the bar in both the sensitivity and reliability needed for the inspection. Asking the right questions of the application and understanding technological capabilities will provide the best foundation for improving quality control.

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