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Ensuring Sterility Standards

Comprehensive Isolator Validation Services

Isolator validation ensures optimal protection for pharmaceutical products and operators. With isolators maintaining positive pressure to prevent contamination, it becomes essential to validate these systems to meet strict industry standards. This process involves ensuring only filtered air enters, maintaining sterility and high air quality.

Containext Technologies specializes in isolator validation, covering various types and manufacturers. Their expertise spans installation (IQ), operational (OQ), and performance (PQ) qualifications, adhering to international standards. With resources for user requirements, acceptance testing, and operational assistance, Containext Technologies offers end-to-end support, helping manufacturers achieve compliance and operational efficiency in sterile production environments​

Features

Air Quality

Ensures the maintenance of filtered air within the isolator, achieving a contamination-free environment that complies with sterility standards for pharmaceutical manufacturing

Pressure Control

Employs positive pressure to prevent unfiltered air from entering the isolator chamber, protecting both products and operators from contamination​

Compliance Testing

Adheres to international guidelines, performing tests like Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to meet regulatory requirements​

Versatile Applications

Validates isolators of various types and manufacturers, ensuring compatibility with multiple safety cabinet designs and sterile environments​

Comprehensive Support

Offers end-to-end assistance, including generating user requirement specifications, conducting acceptance tests, and operational resources to streamline validation processes​

Enhanced Efficiency

Improves sterile production workflows by ensuring isolators function optimally, minimizing risks, and maintaining high-quality output standards

Contact Details

Germany (corporate office)
India (factory- headoffice)

    Containext Technologies specializes in advanced containment solutions for the pharmaceutical and healthcare industries. We offer customized isolators and containment systems that prioritize safety, compliance, and operational efficiency, ensuring a high standard of protection for both workers and environments.

    Office
    Germany (corporate office)
    India (factory- headoffice)
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