Bar Sealer Operational Qualification OQ Protocol | Medical Device

SKU: OQ-BAR
$199.00
$199.00
Unavailable
Our Bar Sealer Operational Qualification (OQ) Protocol is a comprehensive 17 page document developed specifically to address regulatory requirements for qualifying medical device bar sealing equipment/process used to seal sterile medical device packaging. The Bar Sealer Operational Qualification (OQ) Protocol is structured in accordance with ISO 11607 and FDA QSR Requirements. 
  • FDA QSR Compliant
  • MDR EU 2017/745 Compliant
  • ISO 11607-1/2:2019 Compliant
  • ASTM F88, F1886 and 1928 Compliant
  • MS Word Format
  • Digital Content - Instant Download

 

Bar Sealer Operational Qualification Protocol

​Our Bar Sealer Operational Qualification (OQ) Protocol is used to qualify equipment and operating parameters used for the sealing of sterile packaging materials (i.e. Tyvek/Mylar, Foil, PA/PE, Paper/Mylar Pouches, etc.) sealed with any make or model bar sealer. 

Bar Sealer Operational Qualification Protocol Content Overview

The protocol specifies the manufacturing conditions, controls, testing, and required acceptance criteria. The qualification protocol includes the following elements: 
  • The manufacturing conditions, including operating parameters, process limits, and raw material inputs.
  • The data to be collected and when and how it will be evaluated
  • Tests to be performed and detailed acceptance criteria
  • Sampling plan, number of samples and frequency of sampling for both variable and attribute data. The protocol includes a sample size justification section that notes the number of samples required to provide sufficient statistical confidence.
  • ​Provision for addressing deviations from expected conditions and handling of nonconforming data.
  • The qualification protocol includes prerequisite requirements in terms of equipment installation, personnel training and qualification, and verification of materials used in the qualification process and the review and approval of the qualification protocol by appropriate departments.
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To learn more about our Bar Sealer Operational Qualification (OQ) Protocol contact us at info@aplyon.com 
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RELATED LINKS
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Bar Sealer Operational Qualification Protocol
Bar Seal OQ Protocol
Fundamental Qualification Considerations

The three critical operating parameters, common to any make or model sealing machine, are: Temperature, Time and Pressure. (In the case of conveyor fed sealing machines these parameters may translate to Temperature, Speed and Gap).

​A prerequisite for qualification activity is gaining an understanding of the appropriate settings to be used to seal the materials selected. Input from packaging suppliers, preliminary testing such as Design of Experiments and/or Edge of Failure Analysis will help dial in the parameters used during the qualification process.

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