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  • 4 Sided Seal (4SS) Performance Qualification PQ Protocol | Medical Device

4 Sided Seal (4SS) Performance Qualification PQ Protocol | Medical Device

SKU: PQ-4SS
$119.00
$119.00
Unavailable
per item

Our 4 Sided Sealer Performance Qualification (PQ) 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 Performance Qualification (PQ) 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
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4 Side Sealer Performance Qualification Protocol

​Our Four Sided Sealer Performance Qualification (PQ) 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. 

4 Sided Sealer Performance Qualification Protocol Content Overview

The Performance Qualification (PQ) 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 Performance Qualification  (PQ) Protocol  contact us at info@aplyon.com 

RELATED LINKS
Bar Seal Qualification Protocol Bundle (OQ and PQ)    
Tray Seal Qualification Protocols Bundle (OQ and PQ)
4 Sided Seal Qualification Protocol Bundle (OQ and PQ)
Product Stability Shelf Life Procedure
​Accelerated Aging Study

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

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

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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. 

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Product Stability Shelf-Life Procedure | ISO 13485 | FDA QSR Compliant

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The Shelf Life Procedure defines the required testing needed to support medical device shelf life claims. The Shelf Life Procedure provides instruction on product considerations, accelerated aging studies, and post accelerated aging product testing and reports. 
  • ASTM F 1980-16 Compliant
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Accelerated Aging Study

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  • FDA Compliant
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  • HOME
  • STORE
    • ISO 13485 QUALITY SYSTEMS >
      • MANUFACTURING PLUS
      • MANUFACTURING SYSTEM
      • DESIGN PLUS SYSTEM
      • DESIGN SYSTEM
      • BASE PLUS SYSTEM
      • BASE SYSTEM
      • ISO 13485 Quality Management System Manual
    • ISO 13485 PROCEDURE BUNDLES >
      • ISO 13485 Document Control Procedure Bundle
      • Design Control Procedures Bundle
      • Risk Management Procedures Bundle
      • ISO 13485 Process Validation Procedure Bundle
      • Medical Device Sterilization Procedure Bundle
      • Medical Device Labeling Bundle
      • Medical Device Software Procedure Bundle
      • Clinical Evaluation Procedure Bundle
      • Cleanroom Procedure Bundle
      • Complaint Handling Procedures Bundle
    • ISO 13485 QUALITY SYSTEM PROCEDURES >
      • ISO 13485 DOCUMENTATION REQUIREMENTS PROCEDURES >
        • Engineering Change Notice Procedure
        • Document Control Procedure
        • Record Retention Procedure
      • ISO 13485 MANAGEMENT RESPONSIBILITIES PROCEDURES >
        • Management Review Procedure
      • ISO 13485 RESOURCE MANAGEMENT PROCEDURES >
        • Training Procedure
        • Facility Inspection Procedure
        • Respiratory Protection Procedure
        • Biohazard Procedure
        • Lockout - Tagout Procedure
        • Preventive Maintenance Procedure
      • ISO 13485 PRODUCT REALIZATION PROCEDURES >
        • ISO 13485 DESIGN - DEVELOPMENT PROCEDURES >
          • Design Control Procedure
          • Customer Requirements Validation
          • Human Factors - Usability Engineering Procedure
          • Design Review Procedure
          • Risk Management Procedure
          • Design Transfer Procedure
          • Shelf Life Procedure
          • Technology Transfer Procedure
          • Design Verification - Validation Procedure
          • Design Risk Management Procedure
          • Design Analysis Procedure
          • Biocompatibility - Toxicity Testing Procedure
          • ISO 13485 Label Review and Approval Procedure
          • Unique Device Identification Procedure
          • Software Development Procedure
          • Software Clinical Evaluation Procedure
          • Clinical Evaluation Procedure
          • Clinical Investigation Procedure
          • Product Performance Specification Procedure
          • CE Marking Procedure
        • ISO 13485 PURCHASING PROCEDURES >
          • Supplier Management Procedure
          • Purchase Order Procedure
        • ISO 13485 PRODUCTION - SERVICE PROVISION PROCEDURES >
          • Cleanroom Design and Validation Procedure
          • Environmental Controls Procedure
          • Controlled Environment Cleaning Procedure
          • Sterile Load Preparation - Release Procedure
          • Gamma Irradiation Sterilization Validation Procedure
          • Ethylene Oxide EO Sterilization Validation Procedure
          • Software Validation Procedure
          • Installation Qualification (IQ) Procedure
          • Medical Device Process Validation
          • Validation Protocols - Reports Procedure
          • Process Risk Management Procedure
          • Device History Record
          • Identification Procedure
          • Lot Inspection Procedure
          • First Article Inspection Procedure
          • Line Clearance Procedure
          • ISO 13485 Contract Review Procedure
        • ISO 13485 CONTROL MONITORING MEASUREMENT DEVICES PROCEDURES >
          • Calibration System Procedure
      • ISO 13485 MEASUREMENT ANALYSIS IMPROVEMENT >
        • Complaint Handling Procedure
        • Complaint Trending Procedure
        • Nonconforming Material Procedure
        • Corrective - Preventive Action Procedure
        • Internal Audit Procedure
        • Medical Device Report MDR Procedure
        • Product Hold Procedure
        • Remedial Action - Recall Procedure
        • Statistical Techniques Procedure
        • Post Market Surveillance Procedure
        • Post Market Clinical Follow Up Plan
        • Post Market Clinical Follow Up Evaluation Report
        • Periodic Safety Update Report (PSUR) Procedure
        • Vigilance Procedure
        • Failure Investigation Procedure
    • VALIDATION PROTOCOLS >
      • Clinical Investigation Report
      • Clinical Investigation Plan
      • Ethylene Oxide (EO) Product Adoption
      • Accelerated Aging Study
      • Injection Mold Validation Procedure
      • Medical Device Software Development Plan
      • Final Cleaning Orthopedic Implants
      • Bar Sealer Operational Qualification OQ Protocol
      • Bar Sealer Performance Qualification PQ Protocol
      • Bar Sealer Qualification Protocol Bundle OQ - PQ
      • Tray Sealer Operational Qualification OQ Protocol
      • Tray Sealer Performance Qualification PQ Protocol
      • Tray Sealer Qualification Protocol Bundle OQ - PQ
      • 4 Sided Sealer Operational Qualification OQ Protocol
      • 4 Sided Sealer 4SS Performance Qualification PQ Protocol
      • 4 Sided Sealer Qualification Protocol Bundle OQ - PQ
    • CONTRACTS - AGREEMENTS >
      • Medical Device Quality Agreement | US
      • Medical Device Quality Agreement | EU
      • Master Consulting Agreement
  • CONSULTING
    • QUALITY SYSTEM INSTALLATION - TRAINING
    • FDA QSIT AUDIT PREPARATION
    • DESIGN - PROCESS VALIDATION
  • FDA US AGENTS
    • US AGENTS
    • FACILITY REGISTRATION SERVICES
    • FDA FURLS DATABASE DATA ENTRY SERVICES
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