We provide complete services for validation and qualification of HVAC systems and controlled environments to comply with cGMP requirements.
Our services include all aspects of clean room testing & validation including:
Precise calibration and adjustment to ensure optimal performance of HVAC systems.
Setting up differential pressures to maintain cleanroom integrity and controlled environments.
Accurate assessment of air circulation rates to meet specified requirements.
Monitoring and analysis of airborne particle levels for cleanroom compliance.
Evaluating the time required for a controlled environment to return to specified cleanliness levels.
Visualization techniques to assess airflow patterns and ensure efficient ventilation.
Verification of containment systems to prevent contamination.
Ensuring the performance and reliability of HVAC and environmental control systems.
Mapping and analysis of temperature and relative humidity distributions within controlled environments.
Assessment of HEPA filter efficiency and integrity to maintain air quality standards.
Validation protocols and testing procedures developed by Prime Systems are comprehensive and are based on latest international regulatory and cGMP requirements. All instruments used in validation testing are calibrated and a valid calibration certificate is provided for each instrument. Our personnel execute all validation work by following our SOP’s and approved protocols for validation jobs. All personnel assigned to validation jobs are trained on the relevant SOP’s and protocols.
We provide complete services for thermal validation of sterilizers and temperature mapping of controlled temperature storage equipment and storage areas.
Our services include following:
Ensuring sterilization efficacy and reliability through meticulous validation procedures.
Validation processes confirming consistent performance and adherence to sterilization standards.
Comprehensive validation to ensure uniformity and effectiveness in sterilization and drying processes.
Detailed procedures verifying the reliability and efficiency of tray dryers in drying applications.
Precise mapping of temperature distributions for optimal storage conditions of sensitive materials.
Thorough qualification and mapping to maintain temperature integrity for stored products.
Systematic mapping to ensure consistent temperature conditions across warehouse facilities.
Accurate mapping of temperature and humidity distributions for optimal chamber conditions.
Validation protocols and testing procedures developed by Prime Systems are comprehensive and are based on latest international regulatory and cGMP requirements. All instruments used in validation testing are calibrated and a valid calibration certificate is provided for each instrument. Our personnel execute all validation work by following our SOP’s and approved protocols for validation jobs. All personnel assigned to validation jobs are trained on the relevant SOP’s and protocols.
We provide complete services for validation of pharmaceutical production equipment including:
Ensuring that the design of pharmaceutical production equipment meets specified requirements and regulatory standards, laying the foundation for reliable and compliant manufacturing processes.
Verifying that the installation of pharmaceutical production equipment is performed correctly and in accordance with design specifications, ensuring proper functionality and adherence to regulatory guidelines.
Testing and documenting the operational performance of pharmaceutical production equipment under various operating conditions to ensure consistent and reliable functionality throughout its intended use.
Assessing the ability of pharmaceutical production equipment to consistently produce products that meet predetermined specifications and quality standards, confirming its suitability for commercial production.
Validation / Qualification protocols developed by Prime Systems are comprehensive and are based on latest international regulatory and cGMP requirements. All instruments used in validation testing are calibrated and a valid calibration certificate is provided for each instrument.
We provide validation (DQ, IQ, OQ & PQ) services for utilities which include:
Thorough validation ensures the integrity and reliability of compressed air systems, verifying their compliance with regulatory standards and operational requirements. From DQ to PQ, we meticulously assess system design, installation, operation, and performance to guarantee optimal functionality and safety.
Our validation protocols cover every aspect of boiler and steam systems, ensuring their proper design, installation, operation, and performance. Through rigorous testing and qualification procedures, we validate the efficiency, reliability, and safety of these essential utilities, adhering to industry standards and regulations.
Validation services for purified water systems encompass DQ, IQ, OQ, and PQ phases, ensuring the consistent production of high-quality water for various pharmaceutical and industrial applications. We meticulously assess system design, installation, operation, and performance to meet stringent regulatory requirements and quality standards, ensuring the integrity and purity of the water produced.
