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Biotech Calibrators & Controls

Our line of biotech calibrators and controls are used on osmometers across bioprocessing workflows. These products are designed to ensure osmometers’ optimal performance and accuracy of test results across instrument reportable range.

Osmolality is considered a critical quality attribute and critical process parameter in bioprocessing. Using our calibrators and controls to ensure the results are accurate and precise—protecting the quality of your batch samples. These products work hand in hand with our Advanced Instruments osmometers to comply with the pharmacopeia guidelines listed below to perform osmolality testing, calibration and verification.

• United States Pharmacopeia
• European Pharmacopeia

• Japanese Pharmacopeia
• Chinese Pharmacopeia

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Trusted Results With Streamlined Daily Checks

According to the Pharmacopeia guidelines for osmolality testing, it is important to perform a daily calibration check or verification prior to testing your samples, therefore ensuring instrument calibration and performance. Advanced Instruments Calibrators and Controls are manufactured to a tight tolerance so you can quickly spot shifts in performance.

Advanced Instruments osmometers are factory calibrated. You only need to use the Clinitrol 290 and require minimum testing prior to use.

During the preventative maintenance, we recommend the use of the linearity set to verify the calibration check which ensures the accuracy of the result and monitors a full range of instrument performance.

Dedicated to Quality

With more than 65 years of experience in osmolality testing, Advanced Instruments Quality Management System is certified according to ISO 9001 and ISO 13485.

  • Each lot of our osmolality standards is tested and analyzed by the Advanced Instruments laboratory using an osmometer that is calibrated against NIST Traceable Reference Solutions to ensure accurate and precise testing.
  • Certificates of Analysis (COA) are available for each specific lot, providing all required information about the standards. For your convenience, these COAs are available electronically on our website.

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Clinitrol 290 for Calibration Check

Clinitrol is the instrument reference solution and it is used for calibration check. It is a daily system check to strengthen your laboratory’s quality control program.

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Controls for Sample Osmolality Check

In addition to instrument verification, it is important to test an osmolality standard that is closer to your sample osmolality to ensure sample testing accuracy. We offer a wide range of osmolality standards from 0-4000 mOsm/kg H2O. Refer to the “Interpreting Results” page in the instrument user’s guide for each osmolality standard’s expected specification.

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Protinol Control for Protein Based Samples

When testing protein-based samples, Protinol is recommended to use as an additional precise reference solution. It is ready to use and available in three relevant levels: 240, 280, and 320 mOsm/kg H2O.

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Easy & Ready-to-use

The Advanced Instruments Calibrators and Controls are pre-mixed with the right concentration of Sodium Chloride in individual ampules available in either 2 mL or 5 mL. The ampules are designed to be easily opened and ready-to-use.

Open a new ampule before each test. These can be used straight out of the box and are specifically made to work with our Advanced Instruments osmometers.

Calibration For Peace of Mind

Calibration is the process of configuring an instrument to provide a result for a sample within an acceptable range. Calibration precisely adjusts the osmolality of the instrument using the Advanced Instruments calibration standards.

Our instruments are calibrated with a minimum of two points and comply with the pharmacopeia guidelines.

Please see the table below for the different calibration points used for Advanced Instruments osmometers. The zero point calibration standard is used to determine the lowest osmolality value of the instrument to be compliant with the European Pharmacopeia.

Calibration Standards required for Advanced Instruments Osmometers for Biotech

OsmoTECH® XT

OsmoTECH

OsmoTECH PRO

OsmoTECH HT

A2O®

Low Range (mOsm/kg)

0, 500, 1500

0*, 50, 850, 2000*

0*, 50, 850, 2000*

0, 300, 850, 2000

100, 900, 2000

High Range (mOsm/kg) **

1500, 3000, 4000

N/A

N/A

N/A

100, 900, 2000, 3000

* As optional
** Full Range for A2O

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