SERVICES

  • HVAC SYSTEM VALIDATION

  • Duct Leakage Test

  • HEPA Filter Leakage Test

  • Air Flow  and Air Change Rate

  • Differential Pressure

  • Temperature and Humidity

  • Decontamination Time-Recovery Test

  • Particle Counting&Classification of Clean Rooms

  • HEAT DISTRIBUTION TEST OF INCUBATORS, DRYING OVENS, COLD ROOMS, REFRIGERATORS, STABILITY CABINETS AND WAREHOUSE

Determining of the temperature distribution at different points in the risk assessment in equipments and area , monitoring and reporting on the application of temperature and humidity of the unusual scenario.

  • LAMINAR FLOW CABINETS VALIDATION

  • HEPA Filter Leakage Test

  • Air Flow Rate

  • Identification of Air Flow Direction Characteristics

  • Particle Counting

  • QUALITY TEST OF MEDICAL GAS

  • Particle Test

  • HydrocarbonTest

  • Dew Point (Humidity)

  • Carbon dioxide

  • Carbon monoxide

  • WATER (WPU/WFI) SYSTEM VALIDATION

Preparing of validation protocol of WPU/WFI systems, performing of validation study,  finalization of tests carried out by customer and preparing of validation report.

  • CLOSED LOOP  WATER HEATING SYSTEM VALIDATION  

 

Monitoring temperature according to risk assessment on circulation and sterilization of WPU/WFI systems by appropiate equipment. Calculation of lethality rate.

  • FREEZE DRYING (LYOPHILIZATOR) VALIDATION

Heat distribution test of lyophilizators. Determinig of homogenity between the shelves and heating / cooling rates. Control of compressor efficiency and conformity  of sterilization criteria.

  • STERILIZERS  (AUTOCLAVES,  DRY HEAT OVENS, DEPYROGENATION  TUNNELS) VALIDATION

 
According to the risk assessment to determine the temperature distribution in sterilizers by using related standarts and equipment. Calculation of temperature and lethality rate in materials .To check whether sterilizers are appropriate by using biological indicators and Endotoxin Challenge Vials.

  • STEAM QUALITY TESTING &TRAINING

Ipsum Validation provides a range of specialist products, consultancy and training services associated with sterilization processes and steam quality testing to an international market.

GMP AUDIT
 

According to Eudralex Volume 4, Part 1,Chapter 5’ (Production) “On the qualification of suppliers in order to reflect the legal obligation of manufacturing authorisation holders to ensure that active substances are produced in accordance with GMP.”

 

“Audits should be carried out at the manufacturers and distributors of active substances to confirm that they comply with the relevant good manufacturing practice and good distribution practice requirements. The holder of the manufacturing authorisation shall verify such compliance either by himself or through an entity acting on his behalf under a contract. For veterinary medicinal products, audits should be conducted based on risk. “

 

“Audits should be of an appropriate duration and scope to ensure that a full and clear assessment of GMP is made; consideration should be given to potential crosscontamination from other materials on site. The report should fully reflect what was done and seen on the audit with any deficiencies clearly identified. Any required corrective and preventive actions should be implemented.”

 

“Further audits should be undertaken at intervals defined by the quality risk management process to ensure the maintenance of standards and continued use of the approved supply chain.”

 

Audit has been made compulsory.

 

Ipsum Validation finds  the cost/effective solutions to you.  Our auditors have audit experiences over 25 years for pharmaceuticals and radiopharmaceuticals and they are “Lead Auditor” on QMS  approved by IRCA . We audit  and report your raw material and packaging material suppliers  independently in Turkey and abroad.