Heat Seal Validation
Heat seal validation is necessary for medical device manufacturers to meet industry packaging regulations and help verify product sterility and integrity for the end user.
Heat Seal Validation
Heat seal validation requires a series of tests to determine optimal sealing parameters for specific medical device packaging. These parameters can include temperature, pressure, and time. Validation also verifies that the sealing process will produce consistent seals able to meet strength, integrity and uniformity requirements, and can identify potential seal failure before a product is released to market.
ISO 11607-2 recommends that sterile barrier systems and manufacturing processes undergo a validation process across several package options, including pouches and trays. Life Science Outsourcing heat seal validation follows ISO medical device packaging requirements to meet industry regulations and provides comprehensive documentation of the validation process, regular re-validation to support continued compliance, and quality control measures.
Heat Seal Validation Methods
Heat seals are a common method used to ensure a proper seal and to create the sterile barrier. The following are the most common methods used to verify the process and meet industry regulations.
Heat seal qualificationÂ
Heat seal qualification (HSQ) focuses on proving that the process will produce a predefined criteria for strength, integrity, and uniformity under controlled conditions. It’s a necessary stage to verify that the package process is reliable, reproduceable, and capable of maintaining the sterility and integrity of the medical device throughout its intended shelf life. This method typically involves the following steps:Â
- Define seal parametersÂ
- Equipment calibration and validationÂ
- Produce qualification samplesÂ
- Analyze dataÂ
- DocumentationÂ
- Approval and implementationÂ
Installation qualification
The installation qualification (IQ) phase focuses on verifying equipment performance and reliability by testing installation, configuration, and set up according to the manufacturer’s directions and meets predefined requirements and regulatory standards necessary for the intended operation. IQ also establishes a baseline for documentation and is necessary for regulatory compliance. The following steps are part of the IQ process:Â
- Prep and planningÂ
- Receipt and inspection of equipmentÂ
- Verification of installation requirementsÂ
- Installation of equipmentÂ
- Verification of equipment specificationsÂ
- Calibration and configurationÂ
- DocumentationÂ
- ApprovalÂ
Operational qualificationÂ
The purpose of operational qualification (OQ) is to determine that the heat seal equipment is operating correctly within the specified parameters under all anticipated conditions. Operational equipment ranges are tested to verify that it will maintain consistent performance throughout those ranges. OQ requires the following steps:Â
- Definition of operational parametersÂ
- Development of test protocolsÂ
- Execution of test protocolsÂ
- Assessment and equipment functionsÂ
- Recording and analysis of dataÂ
- Identification and resolution issuesÂ
- DocumentationÂ
Performance qualificationÂ
Performance qualification (PQ) is used to verify that equipment will perform as expected under actual product conditions. Given real world variations that can be caused by the operators, machinery or materials, PQ is used to determine that the package will remain sterile regardless of environmental changes. Steps in PQ include:Â
- Selection of production conditionsÂ
- Development of protocolsÂ
- Execution of test runsÂ
- Sample testing and evaluationÂ
- Data collection and analysisÂ
- Resolution of any issuesÂ
- DocumentationÂ
Heat Seal Validation Sample Size
Life Science Outsourcing recommends the following sample size for heat seal validation:Â
Sample Quantity RequirementsÂ
HSQ = 30 samples (10 Low, 10 Nominal, 10 High)Â
OQ = 3 Runs of 30 (30 Low, 30 High)Â
PQ = 3 Runs of 30 ( 30 Nominal, 30 Nominal, 30 Nominal)Â