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EESS | Calibration and Validation Services
EESS | Calibration and Validation Services
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    • Home
    • About EESS
      • About
      • Contact Us
      • EESS Lab Policy Statement
      • EESS Co. Quality Policy
      • EESS Company Profile
    • Services
      • Calibration Services
      • Clean Room Qualification
      • Thermal Validation
      • IQ-OQ-PQ Qualification
      • Steam Quality Test
      • Other Services
      • Onsite Calibration
    • Solutions
      • Pharma industry Services
      • Food Industry Solutions
      • Laboratories Calibration
      • CITRUS Station Solution
    • More
      • Shop
      • Request for Quotation RFQ
      • Customers Feedback
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  • Home
  • About EESS
    • About
    • Contact Us
    • EESS Lab Policy Statement
    • EESS Co. Quality Policy
    • EESS Company Profile
  • Services
    • Calibration Services
    • Clean Room Qualification
    • Thermal Validation
    • IQ-OQ-PQ Qualification
    • Steam Quality Test
    • Other Services
    • Onsite Calibration
  • Solutions
    • Pharma industry Services
    • Food Industry Solutions
    • Laboratories Calibration
    • CITRUS Station Solution
  • More
    • Shop
    • Request for Quotation RFQ
    • Customers Feedback

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Autoclave Validation

Autoclave Validation Services At EESS Company.

We perform Autoclave Validation for Porous and Fluids load Autoclaves.  ​ 

Our engineers perform Cycle Development, and Validation Services.   

We use TQSOFT With Fluke Validation Equipment.

we perform Autoclave Validation to  International Standards for the pharmaceutical, biotechnology and healthcare sectors.  

Our experience and expertise will give you a clear, compliant and transparent autoclave validation package. 

We can qualify your autoclave to EN285:2015, EN17665, PDA Technical Report 01 and PDA Technical Report 48 to meet MHRA, HPRA and FDA expectations. 

We specialise in Autoclave Validation, regularly working with the following manufacturers:  Fedegari, Getinge, Steris, Belimed, and more. ​ 

  • Porous, Fluids and Waste Autoclave 
  • Qualification Installation/Operation Qualification (IQ, OQ) 
  • Autoclave Load Patterns and Load Presentation 
  • Performance Qualification (PQ) 
  • Re-Qualification (RQ) 
  • Steam Quality Testing 

Autoclave Thermal Validation

Autoclave Thermal Validation 

EESS Thermal Validation - Temperature Mapping System

 Our thermal validation software TQSOFT provides compliance with FDA regulation in 21CFR Part 11 

It is providing a Full Automated Reporting and Report Management  

In addition, software provides all the essential elements for meaningful and successful  validation. , all parameters including calibration data associated with a validation study are stored in a specific 

secured, configuration file, printable for hardcopy filing. 

During the test, data is time stamped and stored at a default scan value in an unmodifiable. 

Operators can view in real time any or all parameters being measured with both graphical and digital 

displays. 

The configured validation test data can be printed for hardcopy in both graphical and tabular format. 

We Let you Know all you need from our Study Report With Clear Thermal Validation Reported contain 

Calibration Report and Calibration Check Report - Cycle Analysis - Cycle Mapping Supported With 

Chart , Chart Zoom , Sensor positioning , Data list - Data list Calculations , and finally you will find 

Thermal Validation Summary Report

Find out more

Depyrogenation Validation for Tunnel / Oven

Depyrogenation Validation Services At EESS Company.

We perform Depyrogenation Tunnel / Oven Validation.  ​ 

Our engineers perform Temperature Mapping, and Validation Services.   

We use TQSOFT With Fluke Validation Equipment.

we perform Depyrogenation  Validation to  International Standards 

Our experience and expertise will give you a clear, compliant and transparent  validation package. 


  • Heat Distribution and Penetration Study  
  • Cold and Hot Points Detecting  
  • Depyrogenation Period Calculation  ( Min , Max , Sterilization Time)
  • Qualification Installation/Operation Qualification (IQ, OQ) 
  • Performance Qualification (PQ) 
  • Re-Qualification (RQ) 

 Depyrogenation Tunnel Validation  

Ethylene Oxide ETO Sterilizer Validation

ETO Sterilizer Validation At EESS Company.

We provides ETO Sterilizer Validation services in accordance to ISO 11135 ​ 

The main objective of validation is to ensure that the sterilization process has been consistent in achieving sterility and did not cause undesirable impact on the device or packaging. The tests conducted on ETO sterilized medical devices includes:

  • Sterilization Cycle Development 
  • Physical Performance Analysis
  • Temperature and Relative Humidity monitoring 
  • Pressure monitoring
  • Empty Chamber Studies 
  • Loaded Chamber Studies
  • Validation Maintenance / Revalidation

Our team ensures and prepares validation protocols which specify the procedures and tests to be conducted.  Typical validation processes consist of the following:  

  • Leak Teat
  • Commissioning Cycle
  • Fractional, Half and Full Cycles
  • Cycle Mapping and Load Pattern  



EO Sterilizers Validation  

Sterilizers Validation

Warehouse temperature mapping

Temperature and Humidity Mapping

A temperature mapping study is an exercise to qualify temperature and humidity mapping of storage environments used for temperature sensitive 

products.  

This can include but is not limited to Warehouses (Controlled, uncontrolled, Dedicated or Multi Market), Cold stores/Fridges, Freezers, Containers, Vehicles, Stability Chambers, Incubators)

The temperature mapping report will document any 

recorded Hot & Cold spots as well as recommendations for continuous monitoring positions where required.

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Temperature and Humidity Mapping

Warehouse Temperature Mapping

TEMPERATURE MAPPING FOR WAREHOUSES

TEMPERATURE MAPPING FOR COLD STORES, VEHICLES, CONTAINERS, CABINETS (FRIDGES, FREEZERS, STABILITY CHAMBERS):

TEMPERATURE MAPPING FOR COLD STORES, VEHICLES, CONTAINERS, CABINETS (FRIDGES, FREEZERS, STABILITY CHAMBERS):

  • Empty & With load (product)
  • Summer & Winter
  • External ambient temperature (outside of facility)
  • Date stamp of any notable 

events (e.g. power failure)

  • temperature and humidity mapping during normal operations
  • Impact tests (e.g. HVAC power down, Door open tests)
  • MKT (Mean Kinetic Temperature)

Incubator Temperature Mapping

TEMPERATURE MAPPING FOR COLD STORES, VEHICLES, CONTAINERS, CABINETS (FRIDGES, FREEZERS, STABILITY CHAMBERS):

TEMPERATURE MAPPING FOR COLD STORES, VEHICLES, CONTAINERS, CABINETS (FRIDGES, FREEZERS, STABILITY CHAMBERS):

TEMPERATURE MAPPING FOR COLD STORES, VEHICLES, CONTAINERS, CABINETS (FRIDGES, FREEZERS, STABILITY CHAMBERS):

  • Empty & With load (product)
  • External ambient temperature (outside of 

cabinet/cold store/vehicle) 

  • Date stamp of any notable 

events (e.g. power failure)

  • Impact tests (e.g. door open , Power cut)
  • Mapped during normal operations

Standards and Regulations: HTM2010 Part 3 , BS EN 554 , ANSI/AAMI/ISO 11135 , GMP, FDA , WHO , USP

عربى
  • خدمات المعايرة
  • اختبارت الغرف النظيفة
  • دراسة التوزيع الحرارى
  • اختبار كفاءة المعدات
  • خدمات المعايرة والاختبار
  • مدونة المعايرة والاختبار

EESS | Calibration and Validation Services

27 Zoheny St. , El-Zaher , Cairo , Egypt

0120 888 0773

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