Thus, checking that these critical parameters are happening each time is essential and should be tested (monitored) to ensure a proper seal. Newer models of heat sealers display the temperature and some even have alarms if the temperature varies a few degrees from the set temperature to help ensure a proper seal every time.
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ANSI/AAMI has a few documents that we need to examine on verifying the seal on peel pouches. These documents are ISO/TS and ISO .
In ANSI/AAMI ST79, there is support for risk assessment if any failures occur within the sterilization process. Failed seals on peel pouches are a significant concern, and a way to decrease this is to verify the heat sealer is properly functioning. Thus, having a process in place with a verification test for the sealing function would be part of the department's Quality Management System (QMS) and help reduce sealing failures caused by an improperly working heat sealer.
ANS/AAMI ST90 outlines the QMS process and the requirements for Performance Qualification (PQ). This process is what the user performs on all their equipment to verify that equipment is working correctly (in this case, a heat sealer). PQ is also concerned with obtaining and documenting that the equipment, as installed and operated per procedures, consistently performs following predetermined criteria and yields product meeting its specifications (a proper seal).
Next, we need to look at the standards of survey agencies, like The Joint Commission (TJC) standard E.C.06.2, which states that medical equipment is maintained, tested and inspected. All equipment within a medical device reprocessing department is tagged by the facility's biomedical engineering department, which puts those pieces of equipment into the facility's medical device inventory. The inventory would then include heat sealers within the reprocessing department because they have been tagged.
Within the TJC standard is Infection Control (IC) standard IC.02.02.01, which requires hospitals to reduce the risk of infections associated with medical equipment, devices, and supplies. Therefore, making sure a heat sealer works properly (providing a proper seal) fulfills this requirement. Remember that this process must be documented.
To determine if a heat sealer is working correctly, a medical device reprocessing department should institute a QMS for their heat sealer:
IQ
' Check-in process when the heat sealer arrives.
OQ
' Preventive maintenance program to ensure it is properly functioning and all work should be documented.
' Clinically relevant, evidence-based products for testing and verification of the seal:
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° Seal tests
° Electrical testing
° Other tests
PQ
' Independent testing and verification of the heat-sealing process using clinically relevant, evidence-based products is key to reducing unsterile surgical instruments and hospital infections.
° Daily testing of equipment
° If a poor seal exists, then no sterile barrier is provided by the peel pouch (i.e., ensuring proper sealing).
° Staff training on use and testing of the heat sealer.
° Documentation of training and test results.
The method discussed in the standards for seal verification testing is an Ink Pouch test or the Dye leak penetration test for the routine testing of peel pouch sealing seams as per ISO -1 and ASTM F. This Ink Pouch test or the Dye leak penetration test will show any irregularities that occur (e.g., channels of ink in the seal are a sign of a poor sealing process) and become visible immediately after the single-use dye test pack. It is easy to use, and the process can be documented. (See Figure 2). There are specific dye tests for TYVEK and paper plastic pouches.
Measuring Heat Seal parameters involves Temperature + Pressure + Time. However, maintaining optimal conditions in production and identifying the root cause of poor sealing is a challenge. We measure these parameters by creating controlled seals on a calibrated Laboratory Heat Sealer (ASTM F). The seals are then peeled apart with a Seal Strength Tester to measure either Ultimate Seal Strength (ASTM F88) or Hot Tack Strength (ASTM F). Adjusting sealing temperature and dwell time helps determine the optimal sealing conditions.
Packaging professionals routinely examining heat seal parameters of incoming film, as part of a robust quality system, this can leverage the measured data to fine-tune the heat sealing process during production, optimising sealing conditions. Sealing parameter disparities are common across film suppliers, rolls, and even within a roll. The introduction of new materials with functional and barrier layers has heightened the need for precise sealing tolerances. Minor variations in sealing parameters can significantly impact seal quality, manifesting as weak seals, channel leaks, edge leaks, back seal/end seal junction leaks, and issues like hardened brittle areas due to overheating or unsealed sections due to under-heating.
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