missing translation for 'onlineSavingsMsg'
Learn More
  1. Home
  2. Products
  3. Support Services and Compliance Services
  4. Equipment and Instrument Services
  5. Laboratory Equipment and Instrument Services
  6. Laboratory Equipment and Instrument Calibration and Certification Testing
  7. 13756909

Labconco IQ/OQ Documentation

Numéro de catalogue. 13756909
Change view
Click to view available options
For Use With (Equipment):
Isolater 2
1 product options available for selection
Product selection table with 1 available options. Use arrow keys to navigate and Enter or Space to select.
Numéro de catalogue. For Use With (Equipment)
13756909 Isolater 2
Use arrow keys to navigate between rows. Press Enter or Space to select a product option. 1 options available.
1 options
Numéro de catalogue. 13756909 Fournisseur Labconco Code fournisseur LSKCDMBQ

Pour de laide SVP utiliser la function de clavardage; nous envoyer un couriel à help@thermofisher.com ou appelez le service à la clientèle au 1-800-234-7437.

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.

Spécifications

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