Produkter » Insacal mk II

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Introduction


Insacal mk. II is made especially to perform low conductivity calibration, enabling you to easily validate your conductivity sensors inline. 

The features setting is apart from its, predecessor, Insacal is:

The software in combination with FT unit, which enables a categorization of the measurement. 

The option to make an electrical test of the entire system. 

The low conductivity calibrator has been created as our calibration technicians are often experiencing often a number of difficulties and irregularities at the customers’ sites. It appears to be because of the high documentation requirements in the pharmaceutical industry in relation to water purity.  

Insacal mk. II is made to overcome such difficulties. It is an easy-to-use, hand held low conductivity calibrator made to ensure you acquire the necessary documentation for your WFI (Water For Injection) applications.  

The conductivity calibrator is primarily introduced to the pharmaceutical industry, but is useful in industries with requirements for documentation of the water’s purity, such as in the biotech- and chemical industry. 

By introducing Insacal mk. II Insatech Pharmas main privilege is to make your low conductivity calibrations easy to document and perform, in order to save you hours on your total calibration time.

Contact our product manager for more information about utilization, customization, implementation and price.

How It Works

A significant feature of Insacal mk. II, is that we have poured 20 years of accumulated knowledge into its software, providing it with a transparent, logical and tamper free user interface. With the recomendable FT unit (Flow and Temperature) the conductivity calibrator will categorize each conducted measurement according to a defined set of values, which determines the accuracy of each calibration. The categorization goes as follows: 

A. Any influences during the measuremet are neglible and the measurement is accurate. 

B. There are some influences affecting the measurement, but the data can be used as a rought estimate. 

C. Too many influences are affecting the measurement and it is most likely inaccurate.

The reasoning for making this categorization has several means. 

First, the demands from the particular user at the particular place in the process may be high or lower. Second, flow and temperature are great influencers on the measurement. As such, taking them into account is an important part of performing the calibration. 

For example using a flow which is too low, could mean that contamination from instruments, pipes, hoses etc. could be affecting the conductivity measurement. A low flow could also affect the temperature from the Unit Under Test (UUT) to the reference, which would also result in inaccurate measurements.

Changes in temperature on its part will change the conductivity, as a solutions ability to conduct current, amongst other, depends on the temperature of the media. 

An additional feature of the conductivity calibrator enables you to carry out an electrical test of the entire system, thus providing you with the possibility to reach an uncertainty 4 times better than the 2% uncertainty specified in the USP (United States Pharmacopeia) at 100 µS/cm – when using a beaker, or preferably, the Insacal T9 calibration tank. 

The Insacal mk. II is calibrated at 1,3 µS/cm and 100 µS/cm. The cell constant being determined at 100 µS/cm by the use of a Denmark Federal Measuremet (DFM) Standard Reference Material (SRM) in a calibration process accredited to ISO 17025 by DANAK.

As its predecessor, the low conductivity calibrator enables the user to carry out the calibration in a closed loop, in an open beaker or by using the T9 Calibration Tank – as preferred. As part of the calibration procedure, the Unit Under Test, regardless of setup, will be compared to the reference, which is the Insacal mk. II.

Operation

Our Insacal mk. II, is made to be durable. The casing is made from AISI 304 and is IP 66, which means it is dust proof and is able to withstand powerful water jets. Hence the conductivity calibrator can be cleaned according to the pharmaceutical industry’s standards. 

The low conductivity calibrator is delivered with a shielded sensor to avoid influence from the surroundings, and all wetted parts are CIP-able (Cleaning-in-place). 

The optional flow and temperature (FT) unit is recommended as it aids the assessment of in situ measurements and their validity. In situ calibrations are very easily influenced by flow and temperature, both of which have the potential to affect the accuracy of the conductivity measurements.     

Easily Transported and No Permanent Installation Required

The low conductivity calibrator is hand held weighing less than 4 kg. The sturdy design together with the solid handle makes it easy to transport to the point of use and well suited for use anywhere on-site. Since Insacal mk. II can be easily inserted into the T9 calibration tank, a beaker or a drain valve, no permanent installation is required..

Is the Standard Solution Insufficient?

If the standard solution is insufficient for your specific use, we can, as a pre-order, work out a User Requirements Specification (URS) in accordance with your requirements. 

Documentation from Basic to Full Validation

We work according to well recognized standards, e. g. Good Automation Manufacturing Practice (GAMP). Thus Insatech Pharma documents the various components, the interaction between the components and the total delivery as agreed to with the customer. 

The extent of documentation is as per agreement with the customer, and goes from the basic operations manual to full validation in accordance with common practice of the pharmaceutical industry.

Service and Support

Maintenance is limited to a yearly calibration of the sensor. We can also offer training in the use of Insacal mk. II as part of the delivery. If you choose to sign a service agreement with us, we will ensure it functions correctly and we will take responsibility for timely calibration of it.

Contact our product manager for more information about utilization, customization, implementation and price.

Kontakt mig

Udfyld nedenstående felter, klik send, og vi vil kontakte dig snarest muligt.

 

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Insacal_brochure - [Brochure]

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