In the medical field, patient safety is paramount, and ensuring the sterility of surgical tools is a critical part of this safety. Suture packs as well as other surgical instruments, must be maintained in a sterile condition to prevent infections and other complications during surgery. To achieve this, rigorous package integrity testing is required to confirm that suture packs remain sealed and uncontaminated until the moment they are used.
Suture packs are pre-packaged sets containing surgical sutures and occasionally other related instruments. These packs are sterilized and sealed to ensure that they remain uncontaminated until they are opened for use in surgical procedures. Sutures are crucial for closing wounds and surgical incisions, so maintaining their sterility is essential to prevent infections, promote healing, and reduce the risk of complications.
Applications of Suture Packs
Suture packs are used in a wide range of surgical procedures across various medical disciplines, including:
- General Surgery: For closing wounds and surgical incisions.
- Orthopedic Surgery: To repair torn ligaments and tissues.
- Cardiovascular Surgery: For stitching blood vessels and tissues.
- Emergency Medicine: For stitching wounds in trauma cases.
In each of these applications, the integrity of the suture pack is crucial for maintaining sterility and ensuring that the patient receives the highest standard of care.
CCI Testing of Suture Packs
The integrity of suture packs must be thoroughly tested to ensure they have not been compromised during manufacturing, shipping, or storage. Any breach in the packaging seal could lead to contamination, rendering the sutures unsafe for use. Traditional methods of container closure integrity testing(CCIT) include dye ingress testing and bubble emission testing. However, these methods can be limited in sensitivity, are highly subjective and may not detect all potential leaks, particularly those that are very small or in hard-to-detect areas.
CCI Testing using VeriPac 410
The VeriPac 410 is an advanced inspection system that utilizes force decay technology for non-destructive leak detection in blister packs, sachets, and pouches with limited headspace. This system builds on PTI’s vacuum decay technology, adding a force-based measurement component to improve detection accuracy. The force decay technology measures the force resulting from the deflection of a package’s surface during a standard vacuum test cycle. This measurement allows the VeriPac 410 to accurately identify defective packages, even in those with minimal headspace.
Technology Overview
The VeriPac 410 benchtop inspection system operates with a drawer-style test chamber that is specifically designed for the purpose. The system uses a custom package insert that adapts to the shape of the package, enhancing test sensitivity. The vacuum levels are continuously monitored throughout the test cycle, following the ASTM F2338 Vacuum Decay Leak Test Method. A drop in the vacuum level indicates that air is leaking from the package into the test chamber. After the vacuum phase, a pressure plate maps the surface pressure of the package’s lidding. The system detects defects by recognizing deviations in the pressure pattern, thus pinpointing the location of the defect within the package or cavity. VeriPac 410 technology can be scaled for fully automated inspection on the production line.
Benefits of Force Decay leak testing
- Non-destructive, non-subjective, no sample preparation
- Multiple packages can be tested in a single test cycle
- Great choice for in-process testing
- The test is operator independent and can be performed with minimal training
- The test protocol is programmed into the testing unit, hence force decay tests are repeatable