Labconco IQ/OQ Documentation

Description

• 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.