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.
Ensure your medical device packaging meets industry regulations with Life Science Outsourcing’s heat seal validation services. Our process defines optimal sealing parameters, ensures sterility and integrity, and adheres to ISO 11607-2 standards. Trust LSO to reduce risks, maintain compliance, and provide the documentation needed to bring your products to market efficiently.
Heat seal validation is a process that ensures medical device packaging heat-sealing methods are reliable, consistent, and capable of producing seals able to maintain the sterility and integrity of the device. It requires a series of tests to determine optimal sealing parameters for specific medical device packaging.
Validation provides sterility assurance, safeguards product integrity, meets compliance requirements, and supports quality control efforts.
The validation process includes:
Defining seal parameters
This identifies temperature, pressure, and dwell time parameters.
Performing tests
A series of tests are conducted to establish optimal seal conditions.
Documentation
All test results and parameters are documented for repeatability and traceability.
Periodic revalidation
The sealing process is periodically revalidated to provide ongoing compliance.
Medical device manufacturers utilize heat seal validation to verify their packaging processes are compliant and reliable, while contract package organizations use it to validate processes for clients in the medical device industry. Quality assurance and regulatory affairs teams use this type of validation to oversee compliance outcomes, and packaging engineers use it to design and test packaging systems.
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:
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:
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:
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:
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.
As an FDA-registered and ISO 13485-certified contract manufacturing organization, Life Science Outsourcing (LSO) offers assembly, packaging, sterilization, and specialized capabilities in diagnostics packaging and design. Our unique business model combines comprehensive in-house services and extensive regulatory expertise, allowing us to provide the agility and flexibility needed to expedite market launches while standardizing the supply chain and minimizing risks.
Comprehensive packages for regulatory compliance.
From fractional to full cycles with EtO residual testing.
Secure with 2X qualification.
Tailored to your sterilization needs.
Life Science Outsourcing is an FDA registered and ISO 13485 certified full service Medical Device Contract Manufacturer.
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