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Labconco IQ/OQ Documentation
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Catalog No. 13756909 Shop All Labconco Corporation Products
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For Use With (Equipment):
Isolater 2
Catalog No. For Use With (Equipment)
13-756-909 Isolater 2
1 options

Catalog No. 13-756-909

Supplier: Labconco LSKCDMBQ

Please contact your sales representative for a quote or further ordering instructions.

Description

The pure2 Isolator IQ/OQ Qualification document has comprehensive Installation Qualification (IQ) and Operational Qualification (OQ) protocols. It includes testing procedures, documentation requirements, and criteria to meet standards.

  • Comprehensive IQ/OQ Qualification Documentation – The Pure2 Isolator IQ/OQ Qualification document provides a thorough and structured approach to verifying system installation and operational performance, ensuring compliance with industry standards and regulatory requirements.
  • Installation Qualification (IQ) Protocols -Covers all necessary checks to confirm proper installation, including verification of system components, utility connections, software configuration, and adherence to manufacturer specifications.
  • Operational Qualification (OQ) Protocols - Outlines systematic testing procedures to validate the isolator's functionality under normal operating conditions, ensuring all key parameters perform within specified limits.
  • Detailed Testing Procedures - Includes step-by-step methodologies to assess critical performance aspects such as airflow dynamics, pressure control, leak integrity, and system alarms.
  • Extensive Documentation Requirements - Provides structured templates and forms to record qualification results, ensuring a standardized and auditable process.
  • Clear Acceptance Criteria - Establishes measurable pass/fail benchmarks for each qualification test, allowing for objective evaluation of compliance.
  • Traceability and Regulatory Compliance -; Designed to align with global regulatory requirements, supporting compliance with GMP (Good Manufacturing Practice), ISO 14644-7, and other applicable standards.
  • System Verification and Functional Testing - Ensures that all critical subsystems, including ventilation, decontamination, and control interfaces, perform reliably within defined specifications.
  • Risk Mitigation and Process Validation - Helps identify potential risks related to system operation and provides structured guidance for corrective actions if deviations are observed.
  • Supporting Documentation for Audits - Generates detailed records that facilitate regulatory audits and inspections, demonstrating compliance with qualification requirements.
  • Customizable Protocols - Allows for adaptation to specific user requirements, ensuring flexibility in validation processes while maintaining adherence to regulatory guidelines.
  • Essential for GMP-Validated Environments -; A critical tool for pharmaceutical, biotechnology, and healthcare facilities that require validated isolator performance to support sterile manufacturing and research applications.
  • Comprehensive Training and User Guidance - Includes instructional materials and guidelines to assist personnel in properly executing qualification protocols and maintaining compliance.

Specifications

For Use With (Equipment) Isolater 2
Product Type Comprehensive Qualifications (IQ/OQ/PQ)
For Use With (Application) Tailored Cycle Development Services
Product Title
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