Our Services
Our comprehensive suite of services includes:
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Product Quality and Safety are the Foundation of Regulatory Compliance, where even minor deviations can lead to serious consequences.
Ensuring Optimal Equipment Performance and maintaining a Thorough Documented Evidence Trail are critical for a Successful Qualification Process.
At SOKOL, we partner with Your Operations Team to develop and execute comprehensive qualification protocols, including IQ, OQ, and PQ.
Our Expertise ensures your manufacturing practices not only Meet but Exceed Stringent Regulatory Standards, safeguarding your operations and Reputation from costly risks.
Equipment Qualification
Comprehensive Equipment Qualification: Our services cover the full lifecycle of equipment qualification, from initial risk assessments through to final validation, ensuring that our client’s equipment meets critical regulatory and operational standards for pharmaceutical manufacturing.
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Detailed Documentation and Compliance Support: With tailored qualification plans, protocols, and comprehensive reports, we provide the documentation needed to support regulatory submissions and maintain audit readiness, ensuring seamless compliance and operational efficiency.
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Qualification Project Planning and Execution: Our team provides end-to-end project planning and execution for equipment qualification, managing each phase to achieve regulatory compliance and operational readiness efficiently.
End-to-End Qualification and Commissioning: We offer comprehensive services from initial assessments through to final validation, ensuring that your facility and utilities meet stringent regulatory and operational standards for pharmaceutical manufacturing.
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Critical Utility Validation: Our expertise covers HVAC, water systems, process gases, and cleanrooms, validating the performance and reliability of each system to ensure product integrity and maintain compliance.
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Customized Documentation and Audit Support: We provide tailored commissioning plans, protocols, and reports, including risk assessments and validation master plans, ensuring audit readiness and ongoing regulatory compliance.
Facility and Utilities Qualification and Commissioning
Airflow Visualization Studies
Comprehensive Airflow Visualization Testing: We provide comprehensive airflow visualization and contamination control assessment services for cleanrooms, barrier systems, and interfaces between different classified areas (e.g., Grade A/ISO Class 5 and Grade B/ISO Class 7), ensuring that controlled environments meet strict regulatory standards.
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Advanced Visualization with Neutrally Buoyant Tracers: Using neutrally buoyant tracers in accordance with ISO 14644-3:2005 standards, we capture and verify airflow direction and behavior, allowing for precise identification of contamination control effectiveness and potential cross-contamination risks.
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Professional Video Recording and Compliance Documentation: Equipped with professional video technology, our assessments include comprehensive documentation and video recordings, providing clear, visual evidence of airflow performance to support regulatory compliance and ensure effective, safe operation of controlled environments.
Thorough CTU Mapping and Qualification: We offer expert temperature and humidity mapping for controlled temperature units (CTUs), including refrigerators, freezers, and warehouses, to guarantee consistent environmental conditions essential for the safety and integrity of sensitive products.
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Detailed Mapping Studies: Our team conducts thorough mapping studies using both wired and wireless validation equipment to verify uniformity of environmental conditions and detect any fluctuations within the CTU, ensuring quality and regulatory compliance.
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Regulatory Compliance and Documentation: We deliver detailed reports and documentation to support regulatory requirements, ensuring controlled storage environments meet the highest standards of product safety and integrity.
Cold Storage Temperature Mapping
Sterilization Validation
Cycle Development: Our team designs customized sterilization cycles for Steam-in-Place (SIP) systems and autoclaves, precisely tailored to meet specific sterilization standards and optimized for varying load configurations to achieve maximum efficacy.
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Physical and Biological Testing for Lethality Verification: We perform rigorous physical testing alongside biological indicator (BI) testing to confirm the lethality of the sterilization process, guaranteeing robust microbial control.
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Comprehensive Process Validation: Leveraging advanced validation techniques, we assess temperature uniformity, exposure time, and overall system performance, ensuring consistent, reliable sterilization that meets stringent regulatory requirements.
Validation Services and Deliverable Creation
In addition to our technical proficiency, we provide extensive assistance in deliverable creation and project oversight.
Our committed team collaborates closely with clients to craft thorough validation plans, User Requirements Specifications (URS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) protocols, Requirements Traceability Matrices (RTMs), Validation Summary Reports, and more.
We execute validation studies with efficiency and compliance, delivering precise and coherent documentation to align with project schedules and goals.