Closures, Package Inspection and Labeling

Package Closures and Maintaining Sterility

In the sterile processing department, sterile processing technicians bear direct responsibility for the cleaning, decontamination, inspection, assembly, packaging, sterilization, and storage of surgical instruments. At every stage of this workflow, technicians must strictly adhere to device and packaging manufacturer instructions for use and facility policy. Packaging closures serve an essential role in this chain of infection prevention. An effective closure must maintain sterility until the package is deliberately opened by clinical staff at the point of use. Furthermore, package closures must preserve package integrity while simultaneously allowing the packaging system to support sterilant penetration and removal as required by the chosen sterilization method.

Wrapped packages rely on specific sealing materials to remain intact during processing, handling, and storage. Technicians must secure wrapped packages using a closure method approved by the wrap manufacturer for the sterilization process, commonly process-specific indicator tape. This tape is specifically engineered to hold the wrapping material in place and visually indicate exposure to a sterilization process. It is vital to use only process-specific indicator tapes designed for the specific sterilization modality in use. Everyday office supplies represent severe hazards to sterile packaging; rubber bands, paper clips, staples, and safety pins must never be used to close sterile packaging. These unapproved items cause punctures, tear wrapping fibers, or fail to secure the pack.

Rigid sterilization containers and peel pouches have their own specialized closure requirements. Rigid containers do not use tape; instead, technicians must apply tamper-evident seals as required by the manufacturer instructions for use and facility policy. Tamper-evident seals break upon opening to signal that the container has been accessed. However, technicians and surgical teams must understand that a tamper-evident seal indicates only whether a container has been opened, but does not verify sterility. For paper-plastic and plastic-plastic peel pouches, heat sealing is commonly used. Heat seals must be smooth, continuous, and completely free of gaps, wrinkles, channels, or burns. When using self-seal peel pouches, technicians must fold the flap strictly along the pre-scored manufacturer fold line to prevent channeling that could compromise the sterile barrier.