Specialized Services

We specialize in the following services:

• Heating, ventilation and air conditioning equipment, mainly for the manufacturing, pharmaceutical and food industry;
• Commissioning and testing of all types of air-handling units to the latest required standards (example, ISO14644)
• We are well acquainted with speed controllers and velocity sensors for maintaining positive and negative pressures as well as temperature control for specific areas;
• Air filtration on all units including laminar flow units e.g. Primary, secondary and tertiary filtration;
• Service and repair to normal extract systems and high velocity extract systems.
• HVAC performance verification and cleanroom qualification including full documentation preparation, execution and reporting thereof.
• Cleanroom / Clean bench Testing and Certification includes:
• Complete set of test protocols
• Particle counts;
• Air flow quantity measurements;
• Air Change Rate Calculations;
• Differential Pressure Verifications
• Pressure Display/Monitor gauge verifications;
• Air Flow Direction Visualisation
• DOP Testing
• Temperature/RH Monitoring
• All raw data, room diagrams, HEPA’s and returns, test points, procedures and equipment;
• Equipment is calibrated and certificates are traceable.
• Execution of risk assessments for processes, equipment, utilities, computerised systems and facilities
• Documentation Management – Development, generation and review of qualification documents for new or existing equipment, utilities, computerised systems and facilities (DQ, IQ, OQ, PQ) to comply with cGMP and international standards (WHO, MHRA, FDA, GAMP, etc.); and reporting of the results
• Execution and coordination of tender and qualification process: system qualification such as design, installation and operation qualification and reporting the results.
• Generation and review of commissioning protocols,
• Execute the protocols, analyse and interpret the data collected, resolve any deviations noted during the execution, and prepare final validation reports.
• Set up and plan qualification processes in close co-operation with internal clients/departments.
• Maintenance services including Filter Change outs and Fumigation
• Preparation, report generation and audit presentation of Current VMP.
• Planning, coordination, execution and report generation of investigations
• General process evaluation. This includes reporting of observed deficiencies to the correct persons, and follow up on corrective action liaising with production where necessary.
• Investigation into and solution of process and quality problems as well as preventative planning and action.
• Input into production training needs when so requested.
  
  

• Laboratory Computerised Systems:
  • Development, generation and review of qualification documents for new or existing Laboratory Computerised Systems
  • Execution of risk assessments/reviews against laboratory computerised systems for compliance to data integrity and electronic records requirements as per latest cGMP’s (FDA, MHRA, WHO, etc).
  • Provide assistance with System Administration and Validation (System Creation, Data Backup and Disaster Recovery, Usage Reporting, User Management, System Policy Management, Custom Report Development)
  • Periodic review of laboratory computerised systems relative to System Hardware, Software, System Policies, User Administration, User Access Control and Privileges, Password Management, System Changes, Error Classification and System Audit Trails
  • Development and compilation of all required associated Standard Operating Procedures
    
    
• Cleaning Validation
  • Assistance with development of Cleaning Validation Master Plans/Validation Plans
  • Assistance with Cleaning validation risk assessments for definition of “worst-case “products/molecules
  • Assistance with development of Cleaning Validation Master Plans/Validation Plans
  • Assistance with development of Cleaning Standard Operating Procedures
  • Equipment review for cleaning validation purposes (assessment of hard to clean areas and determination of total surface areas)
  • Assist with development and compilation of cleaning validation protocols
    
    
• Additional Laboratory Services
  • Development and Compilation of Laboratory Information Files.