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 qualification 

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: 

  • Define seal parameters 
  • Equipment calibration and validation 
  • Produce qualification samples 
  • Analyze data 
  • Documentation 
  • Approval and implementation 

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: 

  • Prep and planning 
  • Receipt and inspection of equipment 
  • Verification of installation requirements 
  • Installation of equipment 
  • Verification of equipment specifications 
  • Calibration and configuration 
  • Documentation 
  • Approval 

Operational qualification 

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: 

  • Definition of operational parameters 
  • Development of test protocols 
  • Execution of test protocols 
  • Assessment and equipment functions 
  • Recording and analysis of data 
  • Identification and resolution issues 
  • Documentation 

Performance qualification 

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: 

  • Selection of production conditions 
  • Development of protocols 
  • Execution of test runs 
  • Sample testing and evaluation 
  • Data collection and analysis 
  • Resolution of any issues 
  • Documentation 

Heat Seal Validation Sample Size

Life Science Outsourcing recommends the following sample size for heat seal validation: 

Sample Quantity Requirements 

HSQ = 30 samples (10 Low, 10 Nominal, 10 High) 

OQ = 3 Runs of 30 (30 Low, 30 High) 

PQ = 3 Runs of 30 ( 30 Nominal, 30 Nominal, 30 Nominal) 

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