4 Sided Seal (4SS) Qualification Protocols Bundle OQ - PQ | Medical Device

$199.00
$199.00
Unavailable
per item

4 Sided Sealer Sealer Operational Qualification (OQ) and Performance Qualification (PQ) Protocol Bundle product includes a 4 Sided Sealer OQ and a PQ Protocol. Each protocol is a comprehensive 22 page document developed specifically to address regulatory requirements for qualifying medical device sealing equipment/process used to seal sterile packaging. The 4 Sided Sealer OQ and PQ Protocols are 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: 4SS-BUNDL

4 Sided Sealer Qualification Protocol Bundle

​Our 4 Sided Sealer Qualification Protocol Bundle includes an Operational Qualification (OQ) Protocol and a Performance Qualification (PQ) Protocol  used to qualify process/equipment used to sterile packaging materials (i.e. Tyvek/Mylar, Foil, PA/PE, Paper/Mylar Pouches,, etc.) sealed with any make or model 4 sided sealer. ​

4 Sided Sealer Qualification Protocol Content Overview

Each protocol (OQ and PQ) specifies the manufacturing conditions, controls, testing, and required acceptance criteria. The OQ and PQ qualification protocols include 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) and Performance Qualification  (PQ) Protocols contact us at [email protected] 

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