วันนี้การทดสอบบรรจุภัณฑ์ทางด้านยาและเวชภัณฑ์ (CCI) หันมาทำกันแบบ NDT ด้วยวิธีการที่อยู่ในรูปแบบของการตรวจวิเคราะห์ มากกว่าการสุ่มตัวอย่างและดูความน่าจะเป็นเหมือนสมัยก่อน
อาจด้วยเพราะเทคโนโลยีที่ก้าวหน้ามากขึ้น และค่าใช้จ่ายที่สามารถเข้าถึงได้ ด้วยผลลัพธ์ที่แน่นอนกว่า แม่นยำกว่า
เราจึงเห็นแนวโน้มผู้ผลิตยา และเวชภัณฑ์ทางการแพทย์ หันมาใช้เทคโนโลยี Vacuum Decay แบบ Non-Destructive กันมากขึ้น
When assuring the quality of all packaged products, testing container closure integrity (CCI) is critical, especially as related to parenteral pharmaceuticals. If there is a breach of the seal, even a microscopic one, it affects the sterility and the stability of the product – the drug may not be as effective due to oxidation or moisture ingress impacting the active ingredient.
But more importantly, a defect in the seal can lead to patient safety concerns. Parenterals are sterile preparations intended to be administered directly into the systemic circulation in humans or animals (think solutions, suspensions, and powders for injection, infusion, or implants).¹ A compromised parenteral container can act as a vehicle for microbialtransmission and pose a significant risk to patient safety. Once bacteria find their way into the container, the drug is no longer a treatment but instead is a threat to the patient.
Therefore, packaging and closure of such containers must be up to high quality standards, as described by pharmacopeias. For example, the United States Pharmacopeia (USP) chapter 1207 “Package Integrity Evaluation—Sterile Products” provides guidance that emphasizes the importance of using reliable and sensitive methods for CCI testing and sets out recommendations on developing and validating a compliant CCI test.² This article will explore the need for sensitive and fast automated CCI testing technologies that are also reliable and how existing solutions can help achieve optimum quality goals for pharmaceutical manufacturers.
MOVING TOWARD MORE RELIABLE TESTING
Traditionally, to ensure that the container closure is preserving the sterility of a drug package throughout its shelf life, methods such as water bath, dye, and microbial ingress tests have been used. Particularly, dye ingress (also known as the liquid tracer test) is still widely used across the pharmaceutical industry due to its simplicity and versatility. However, these traditional methods are destructive, time-consuming, and limited in their effectiveness and reliability, as they are probabilistic methods. Often, probabilistic methods lack standardization within the industry. In addition, test operators may not be in control of certain test elements, and results obtained may be subjective.⁴
In light of these inadequacies, USP chapter 1207 was revised in 2016 to urge the industry to move away from probabilistic test methods in favor of deterministic ones that allow more control of variables, perform uniformly under different conditions, and detect even the smallest leaks with reliability.²
“There is a huge shift in the industry toward deterministic and quantitative test methods,” says Oliver Stauffer, Chief Executive Officer at PTI – Packaging Technologies & Inspection. “This includes vacuum decay, headspace analysis, and high voltage leakage detection (HVLD) for parenteral products. The industry is currently moving away from dye ingress and microbial ingress methods because there are so many blind spots in applying them and there’s a huge false sense of assurance.” Vacuum decay is one deterministic method that is known to provide reproducible and reliable results for CCI testing of high-risk package applications. The test involves placing a package in a test chamber, applying vacuum, and monitoring the vacuum level for any change, which would indicate the presence of a leak.⁵ On the other hand, high voltage can also be used to quantitatively detect leaks without destroying the sample. When it is applied to a non-conductive package material that contains a semi conductive product inside, a spike in the voltage reading would indicate a defect in the packaging.⁶ Both methods have proven to be reliable non-destructive testing technologies and, depending on the specific characteristics of the product and container, one or the other can be chosen for inspection.
#nondestructivetesting #containerclosureintegrity #pharmaceuticalpackaging #qualityassurance #leakdetection #futureofpharma
