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TRANG CHỦ Sản phẩm Hamilton Thiết bị trong sản xuất Calibration and Validation

GMP, GLP, ISO 9001, EN 45000, calibration, verification, traceability, certification from an accredited organization: key words that are increasingly important. The calibration of pH and Redox electrodes has never been easy. All calibration procedures assume that the labeled values of the calibration buffers are correct. But buffer values can change over time and so can your results.

 

 

 

 

 

 

 

 

 


 

pH Buffers

All calibration procedures assume that the labeled values of the calibration buffers are correct. But buffer values can change over time and so can your results. A complete range of patented buffer solutions provides pH stability up to 5 years, something never achieved before. The pH buffers 9.21 and 10.0 are even stable in air. High buffering capacity provides rapid, stable calibration. The growth of fungus and micro-organisms is prevented.

 

 

 

 

 

 

 

 

 

 


ORP Buffers

All calibration procedures assume that the labeled values of the calibration buffers are correct, but buffer values can change over time and so can your results. Therefore it is essential to have reliable ORP buffers on hand. Hamilton ORP buffers are stable for 2 years even if they have been used. The growth of fungus and micro-organisms is prevented.

 

 

 

 

 

 

 

 

 

 


 

Conductivity Standards

 

For measurements in the low conductivity range stable and reliable calibration standards have been completely lacking up to now. Since a conductivity standard is not a buffer solution, the lower the value of the conductivity standard, the greater the effect of entry of CO2 or contamination. Hamilton is the first manufacturer to offer patented conductivity standards of 1.3 and 5 µS/cm with a certified accuracy of  ±1% and a lifetime of 1 and 3 years, respectively. The procedure for determining conductivity was developed in collaboration with DFM. Many metrological institutes choose Hamilton standards because of their unprecedented stability and independent verification by PTB. During an interlaboratory test among prestigious European metrological institutes Hamilton standard were used as measurement solutions.

 

 

 

 

 

 

 


 

Cell Density

 

Two different technologies are summarized under cell density monitoring: viable cell density and total cell density. The viable cell density measurement is based on capacitance and gives the user a deep insight on their cell culture or fermentation. It’s insensitive to microcarriers and cell debris. The total cell density measurement is based on turbidity, resp. on optical density measurement at NIR (Near Infra-Red) wavelengths. The measuring loops for viable and total cell density monitoring consist of an Incyte resp. Dencytee sensor, an individual pre-amplifier and an Arc View Controller. The controller can display both parameters at once using the 2 (Arc View 265) or 4 (Arc View 465, 465 XL) channel inputs. Additionally Arc pH and DO sensors with a wireless module can be displayed on the controller giving the user the ability to regard all relevant parameters of a cell culture or fermentation on one screen.

 

 

 

 

 

 

 


 

Validation Services

 

Leave the paperwork to us

Qualified measuring systems are essential in the pharmaceutical industry. The execution of an Installation Qualification (IQ) and Operation Qualification (OQ) are important components. Documentation according to GMP (Good Manufacturing Practice) guidelines causes a lot of work for many companies.

Hamilton offers a comprehensive solution for the qualification (IQ/OQ) of sensors and their documentation. Qualified service engineers test the functionality and set parameters of the sensors using certified testing equipment.

Your benefits

  • Documents for qualification by GMP guidelines
  • Certified testing equipment is provided
  • Documentation of the testing equipment and sensor information
  • Sensor calibration and comparison with specifications
  • Verification of the measurement in the system
  • IQ/OQ report

sensor qualification


 

Maintenance Services

 

Comprehensive maintenance work and spare parts service

Would you like your sensors or accessories to be checked, maintained or repaired by Hamilton? Our comprehensive maintenance work and the spare parts service enable your process to be securely and reliably sustainable.

Hamilton's good return system allows a straightfoward completion of logistics. The returned products are cleaned, maintained and function tested. You will be informed of every process step and receive a comprehensive test report. Hamilton supports you also with replacement equipment.

 

 

 

 

 

 

Your benefits

  • Reliable repair and maintenance of sensors, housings and instruments
  • Evaluation of sensor data for targeted troubleshooting analysis
  • Professional function testing, firmware updates for Arc sensors and accessories, calibration and re-qualification
  • Customer-specific performance tests

 

Maintenance work - a complete service report documents the work carried out

 

Oxygen sensors
  • Test of the responsive behavior
  • Calibration with air and nitrogen 5.0
  • With amperometric sensors: replacement of the electrolyte, cleaning of the internal body, replacement of the cathode (if necessary). O-ring replacement, membrane body replacement
  • Check of the temperature probe
  • Sensor quality check of VisiFerm DO

 

pH sensors

  • Test of the response behavior
  • Calibration with buffer solutions traced back to NIST
  • Cleaning of the diaphragm and, if necessary, reactivation of the glass membrane

 

Conductivity sensors

  • Test of the response behavior
  • Calibration with traced conductivity standards
  • Cleaning of the sensors
  • Check of the temperature probe

 

Cell density sensors

  • Test of the response behavior
  • Calibration with traced conductivity standards
  • Cleaning of the sensors
  • Function test with display device

 

Housings

  • Cleaning of instruments
  • Replacement of O-rings
  • Check of alignment
  • Check of the pneumatics
  • Function test

 

Beverly - portable oxygen measuring device

  • Cleaning of the device (housing, tubes, VisiFerm DO B sensor, instrument)
  • Replacement of parts subject to wear and tear
  • Pressure/tightness test
  • Display and sensor firmware update
  • Check of sensor quality
  • Calibration of sensor in air and nitrogen 5.0
  • Maintenance report