4 Sided Seal (4SS) Operational Qualification OQ Protocol | Medical Device

$119.00
$119.00
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per item

Our 4 Sided Sealer Operational Qualification (OQ) Protocol is a comprehensive 22 page document developed specifically to address regulatory requirements for qualifying medical device 4SS sealing equipment/process used to seal sterile packaging. The 4 Sided 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
SKU: OQ-4SS

4 Side Sealer Operational Qualification Protocol

​Our Four Sided 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 four sided sealer. ​
The Operational Qualification (OQ) 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.

​To learn more about our 4SS Operational Qualification (OQ) Protocol contact us at [email protected] 

RELATED LINKS
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4 Sided Seal Qualification Protocol Bundle (OQ and PQ)
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