Validation & Qualification Services

Validation  and qualification are the processes that  ensure that the equipment, systems, processes, and methods used in pharmaceutical manufacturing are adequate and compliant with regulations. Validation is to ensure that a process or piece of equipment is working as intended, while qualification focuses on making sure that a piece of equipment or system is suitable for its intended use and meets the specific requirements. 

  • Clean Room Validation

    QSGroup’s clean room  and monitoring system validation service  ensures that clean rooms and facilities used in the production of pharmaceuticals are adequate and compliant with regulations.

    Clean room validation consists of a series of measurements and tests to ensure that environmental characteristics such as temperature, humidity, pressure, and particle concentration, meet the specific requirements for drug manufacturing. These tests are conducted using specific measuring instruments and may include measuring differential pressure, particle concentrations, and air velocity.

    Monitoring systems are validated to ensure that they can detect and record critical environmental conditions such as particle concentrations or temperature, and that they can generate alarms in the event of out-of-specification conditions.

    Once the clean rooms and monitoring systems have been validated, our service also supports you in periodic retrofitting to ensure that they continue to function as expected over time.

  • Smoke Study

    Our 21 CFR 11 compliant Smoke Study service ensures maximum data integrity. We only use high-quality professional equipment to perform the tests in order to provide accurate and reliable results. 

    The smoke study is an assessment that uses visual and/or instrumental techniques to verify the quality of the air and the distribution of flows within a clean room. This is critical to ensure that the working environment is adequate for carrying out contamination-sensitive activities, such as pharmaceutical manufacturing or biomedical research. The result of the study provides information on any air circulation problems and the need for any corrections to ensure air quality and the protection of sensitive products. 

    The study of visualization of air flows in clean rooms is carried out using smoke generators which, by producing a visible cloud, shows the circulation of air in the room. This method is perfect for identifying any circulation problems.

    The results of the test are documented with video footage, which is useful both as a reference for future evaluations and to verify any corrections made, and to verify compliance with established standards and procedures.

  • Isolator validation, open RABS, closed RABS

    Our Isolator/RABS Validation Service  ensures that production systems are safe, reliable, and comply with quality standards. 

    QSGroup’s insulator validation consists of eight tests:

    • The first test, through the verification  of the number of air changes, allows to evaluate the performance of the isolator in terms of air circulation within the system.
    • The second test is the verification of the integrity of the absolute filters (2 filters). This verifies that the filters are able to properly remove contaminants and particles from the air circulating inside the isolator.
    • The third test, known as the leak test, verifies the integrity of the isolator by observing that there are no leaks within the system, and that the isolator maintains a properly sealed environment.
    • The fourth test we perform is the glove breach test which verifies that the seals of the insulator sleeves are properly sealed and there are no leaks inside the system.
    • The fifth test is the “at-rest” (2 points) and “in operation” (2 points) particle verification. This test allows you to assess the air quality inside the isolator both when the system is idle and when it is operating.
    • The sixth test is the recovery time test, which allows you to assess how long it takes for the isolator to return to optimal condition after changing settings or interrupting the manufacturing process.
    • The seventh test is the smoke test which, by visualizing the air flows inside the isolator, allows you to evaluate the quality of the air and its distribution within the system.
    • At closing, we perform biological validation and evaluate the correct sterilization cycle. This test verifies that the isolator is properly sterilized and that there are no biological contaminants within the system.

    QSGroup offers you a  comprehensive insulator validation service that  ensures that your system meets the required quality and safety requirements. 

  • Validation of glove boxes and fume hoods

    Our validation service for fume hoods, laminar flow hoods and glove boxes, offers comprehensive performance verification to ensure process safety and quality. 

    Our team performs validation to identify any anomalies and determine the class of the hoods through particle testing in accordance with ISO 14644 or GMP, through:

     

    • Determination of Laminar Flow Velocity and Frontal Barrier
    • Smoke test
    • Verification of security and alarm systems
    • testing the integrity of the P.A.O.
    • Check operating hours (if any) 

    At the end of the tests, we return you a detailed report with all the results.

  • Autoclave Validation

    Our autoclave validation service aims, through a series of specific tests, to ensure that your machine is in perfect working order. 

    Our team provides validation services for autoclaves through:

    • Verification of the machine’s nameplate data
    • Verifying the Installation
    • Functional verification
    • Check alarm list (if any)
    • Operational Qualification Pre-requisites
    • Verification of safety and user interface (if any)
    • Calibration of control instrumentation (temperature probes and pressure transducer)
    • No-load/load Thermal Mapping 1

    Thanks to our autoclave validation service, you can be sure that your machine is safe, reliable and compliant with the required standards. 

  • Integrity Testing of HEPA/ULPA Absolute Filters

    The integrity tests of the HEPA and ULPA absolute filters are carried out with certified instrumentation to verify that they are able to function correctly and protect the environment from potentially dangerous contamination.

    The documentation relating to the tests is drawn up and managed in compliance with current regulations.

  • Thermo-hygrometric mapping

    The thermal  and humidity mapping service for warehouses, climatic rooms and refrigerators in the pharmaceutical sector, analyzes the internal temperature and humidity to verify that they meet the standards required for the storage of pharmaceutical products. 

    At QSGroup we use measuring tools to obtain a precise thermo-hygrometric map, with relative report, of the distribution of temperature and humidity within the place. Map and report identify any problems, and implement solutions to keep the environment constant and suitable for the storage of pharmaceutical products.

  • Qualification and requalification of HVAC systems

    The qualification and upgrading of HVAC systems is essential to ensure the safety and quality of pharmaceutical production. HVAC systems must maintain a controlled and stable indoor environment, both in terms of temperature and humidity, to preserve the purity and stability of pharmaceutical products. 

    The HVAC system qualification and requalification process involves verifying environmental contamination control systems, such as negative pressure and physical barriers, to ensure that there is no chance of cross-contamination between different production areas. 

    The service is carried out by our team of specialized technicians who perform checks and verifications based on specific industry regulations, such as ISO and GMP.

  • Particle Contamination Class Verification

    The Particulate Contamination Class Verification Service measures particles in the air in pharmaceutical environments, both when they are inoperative (At rest) and during their operation (In operation). Particle contamination verification is performed through the use of particle counters to determine the concentration of airborne particles and classify these environments according to industry standards. Particulate contamination helps identify any problems and take corrective measures to maintain a clean and safe environment for drug production.

  • Preparation of impact assessments, gap analysis and risk analysis

    QSGroup offers Impact Assessment, Gap Analysis and Risk Analysis services, to ensure that the processes and business activities of the pharmaceutical sector are safe, effective and compliant with regulatory standards such as GXP and ISO.  

    In detail:

    • Impact assessment is a process of assessing the impact that a change, such as new legislation, will have on business activities and processes.
    • Gap analysis is a process that identifies the differences between the current situation and a desired state, in order to identify the necessary interventions for improvement.
    • Risk analysis is a process that identifies potential risks associated with a situation or activity, and assesses the likelihood and impact of these risks.

Clean Room Validation

QSGroup’s clean room  and monitoring system validation service  ensures that clean rooms and facilities used in the production of pharmaceuticals are adequate and compliant with regulations.

Clean room validation consists of a series of measurements and tests to ensure that environmental characteristics such as temperature, humidity, pressure, and particle concentration, meet the specific requirements for drug manufacturing. These tests are conducted using specific measuring instruments and may include measuring differential pressure, particle concentrations, and air velocity.

Monitoring systems are validated to ensure that they can detect and record critical environmental conditions such as particle concentrations or temperature, and that they can generate alarms in the event of out-of-specification conditions.

Once the clean rooms and monitoring systems have been validated, our service also supports you in periodic retrofitting to ensure that they continue to function as expected over time.

Smoke Study

Our 21 CFR 11 compliant Smoke Study service ensures maximum data integrity. We only use high-quality professional equipment to perform the tests in order to provide accurate and reliable results. 

The smoke study is an assessment that uses visual and/or instrumental techniques to verify the quality of the air and the distribution of flows within a clean room. This is critical to ensure that the working environment is adequate for carrying out contamination-sensitive activities, such as pharmaceutical manufacturing or biomedical research. The result of the study provides information on any air circulation problems and the need for any corrections to ensure air quality and the protection of sensitive products. 

The study of visualization of air flows in clean rooms is carried out using smoke generators which, by producing a visible cloud, shows the circulation of air in the room. This method is perfect for identifying any circulation problems.

The results of the test are documented with video footage, which is useful both as a reference for future evaluations and to verify any corrections made, and to verify compliance with established standards and procedures.

Isolator validation, open RABS, closed RABS

Our Isolator/RABS Validation Service  ensures that production systems are safe, reliable, and comply with quality standards. 

QSGroup’s insulator validation consists of eight tests:

  • The first test, through the verification  of the number of air changes, allows to evaluate the performance of the isolator in terms of air circulation within the system.
  • The second test is the verification of the integrity of the absolute filters (2 filters). This verifies that the filters are able to properly remove contaminants and particles from the air circulating inside the isolator.
  • The third test, known as the leak test, verifies the integrity of the isolator by observing that there are no leaks within the system, and that the isolator maintains a properly sealed environment.
  • The fourth test we perform is the glove breach test which verifies that the seals of the insulator sleeves are properly sealed and there are no leaks inside the system.
  • The fifth test is the “at-rest” (2 points) and “in operation” (2 points) particle verification. This test allows you to assess the air quality inside the isolator both when the system is idle and when it is operating.
  • The sixth test is the recovery time test, which allows you to assess how long it takes for the isolator to return to optimal condition after changing settings or interrupting the manufacturing process.
  • The seventh test is the smoke test which, by visualizing the air flows inside the isolator, allows you to evaluate the quality of the air and its distribution within the system.
  • At closing, we perform biological validation and evaluate the correct sterilization cycle. This test verifies that the isolator is properly sterilized and that there are no biological contaminants within the system.

QSGroup offers you a  comprehensive insulator validation service that  ensures that your system meets the required quality and safety requirements. 

Validation of glove boxes and fume hoods

Our validation service for fume hoods, laminar flow hoods and glove boxes, offers comprehensive performance verification to ensure process safety and quality. 

Our team performs validation to identify any anomalies and determine the class of the hoods through particle testing in accordance with ISO 14644 or GMP, through:

 

  • Determination of Laminar Flow Velocity and Frontal Barrier
  • Smoke test
  • Verification of security and alarm systems
  • testing the integrity of the P.A.O.
  • Check operating hours (if any) 

At the end of the tests, we return you a detailed report with all the results.

Autoclave Validation

Our autoclave validation service aims, through a series of specific tests, to ensure that your machine is in perfect working order. 

Our team provides validation services for autoclaves through:

  • Verification of the machine’s nameplate data
  • Verifying the Installation
  • Functional verification
  • Check alarm list (if any)
  • Operational Qualification Pre-requisites
  • Verification of safety and user interface (if any)
  • Calibration of control instrumentation (temperature probes and pressure transducer)
  • No-load/load Thermal Mapping 1

Thanks to our autoclave validation service, you can be sure that your machine is safe, reliable and compliant with the required standards. 

Integrity Testing of HEPA/ULPA Absolute Filters

The integrity tests of the HEPA and ULPA absolute filters are carried out with certified instrumentation to verify that they are able to function correctly and protect the environment from potentially dangerous contamination.

The documentation relating to the tests is drawn up and managed in compliance with current regulations.

Thermo-hygrometric mapping

The thermal  and humidity mapping service for warehouses, climatic rooms and refrigerators in the pharmaceutical sector, analyzes the internal temperature and humidity to verify that they meet the standards required for the storage of pharmaceutical products. 

At QSGroup we use measuring tools to obtain a precise thermo-hygrometric map, with relative report, of the distribution of temperature and humidity within the place. Map and report identify any problems, and implement solutions to keep the environment constant and suitable for the storage of pharmaceutical products.

Qualification and requalification of HVAC systems

The qualification and upgrading of HVAC systems is essential to ensure the safety and quality of pharmaceutical production. HVAC systems must maintain a controlled and stable indoor environment, both in terms of temperature and humidity, to preserve the purity and stability of pharmaceutical products. 

The HVAC system qualification and requalification process involves verifying environmental contamination control systems, such as negative pressure and physical barriers, to ensure that there is no chance of cross-contamination between different production areas. 

The service is carried out by our team of specialized technicians who perform checks and verifications based on specific industry regulations, such as ISO and GMP.

Particle Contamination Class Verification

The Particulate Contamination Class Verification Service measures particles in the air in pharmaceutical environments, both when they are inoperative (At rest) and during their operation (In operation). Particle contamination verification is performed through the use of particle counters to determine the concentration of airborne particles and classify these environments according to industry standards. Particulate contamination helps identify any problems and take corrective measures to maintain a clean and safe environment for drug production.

Preparation of impact assessments, gap analysis and risk analysis

QSGroup offers Impact Assessment, Gap Analysis and Risk Analysis services, to ensure that the processes and business activities of the pharmaceutical sector are safe, effective and compliant with regulatory standards such as GXP and ISO.  

In detail:

  • Impact assessment is a process of assessing the impact that a change, such as new legislation, will have on business activities and processes.
  • Gap analysis is a process that identifies the differences between the current situation and a desired state, in order to identify the necessary interventions for improvement.
  • Risk analysis is a process that identifies potential risks associated with a situation or activity, and assesses the likelihood and impact of these risks.

Contamination Control

Solutions for every step of the contamination control process

We support our customers through comprehensive, tailor-made contamination control solutions, a highly trained team of experts, and a dedicated 24/7 support service.< /span>

Products

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