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BIOTECH CALIBRATORS & CONTROLS

Designed to ensure osmometers’ optimal performance and accuracy of test results across instrument reportable range.

Confidence in Your Osmolality Testing

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 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

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. Our Calibrators and Controls are manufactured to a tight tolerance so you can quickly spot shifts in performance.

Our 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, our Quality Management System is certified according to ISO 9001 and ISO 13485.

  • Each lot of our osmolality standards is tested and analyzed by our 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.

Clinitrol­™ 290 for Calibration Check

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Controls for Sample Osmolality Check

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Osmolality Linearity Sets for Range Validation

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Protinol™ Control for Protein Based Samples

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Easy & Ready-to-use

Our 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 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 our 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 our 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 Our 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

* Optional
** Full Range for A2O

What our customers say

We had a demo of the [OsmoTECH PRO] instrument after seeing it at BPI East. The sales managers were prompt in setting up a lunch and learn. The instrument itself was very easy to run samples on and allowed for true load and walk away functionality. The sales managers were thorough professionals, waiting for our PO to go through and working with us to ensure we received the item within a week of ordering. It has the ability to run 20 samples at a time and is great value for the money spent.

Kanaka Bhere

Boehringer Ingelheim Animal Health

The [OsmoTECH PRO] instrument is extremely effective, easy to set up and validate, gives quick results and is extremely accurate.

David Longino

Aspek Pak

The [OsmoTECH PRO] is great for accurate and precise osmolality, giving reliable and reproducible measurements.

Varun Khurana

Glaukos

This [OsmoTECH] instrument was a dream come true. The administrator can lock down features and dictate what users can and cannot do. Very easy to use and extremely reliable instrument.

Troy Franz

Paragon Bioservices

The best part of the [OsmoTECH] instrument is it gives accurate and reproducible results for any solution and most importantly in less than a minute you have the results.

Brijeshkumar Pandya

Nivagen Pharmaceuticals Inc.

[The OsmoTECH] achieves high quality and reproducible results. Easy instrument to use and well-presented software.

Claudia Chadford

Touchlight Genetics

[The OsmoTECH PRO] instrument is simple to operate with minimal consumables.

Greg Hautke

Baxter Healthcare

This [OsmoTECH PRO] osmometer is an accurate and convenient tool for the needs of our lab. Our lab works in the developmental stage of pharmaceuticals, and requires quick, precise bursts of osmolality checking for QC - and this instrument (with a load capacity of 20 samples) takes care of those needs. With developmental drugs, limited sample volume is often an issue - this instrument only needs 30uL (and takes ~90 seconds a measurement).

Sasha Sheptovitsky

Alexion Pharmaceuticals

Osmolality measurements are easy and reliable with this [OsmoTECH PRO] instrument.

Kevin Kent

Boehringer-ingelheim

[The OsmoTECH PRO is] very easy to use for all technicians in a quality control lab. Small sample size. Friendly technicians that explained how to use the product very well.

Cathy Gladkowski

Biologos LLC

[The OsmoTECH PRO is] very easy to use due to short analysis time and sample preparation.

Karthik Venkatachalam

Pfizer

[The OsmoTECH PRO is a] great system for multiple sample testing. Very straightforward and easy to use.

Bobby Grigoropoulos

Fresenius Kabi USA

[The OsmoTECH XT is] easy to use, reliable and self-navigating options menu.

Alexander Shapiro

Precision NanoSystems

The OsmoTECH PRO is working pretty well so far! ... As far as reproducibility, data integrity, ease of use etc. I think it is a very good upgrade for us! On the whole we’re quite happy, I'd recommend this device to a colleague looking for a new high throughput osmometer.

Sean Clements

Takeda

The [OsmoTECH] is highly effective and obtained results are of high quality. With this instrument I can develop my formulation for meeting the osmolality criteria for drug products.

Siva Bingi

Intas Pharmaceuticals

[The OsmoTECH is] easy to use and robust piece of equipment that met all our user and regulatory requirements. The hardware is sleek, efficient and easy to use. The integrated software has built in data integrity controls and is thoroughly tested through validation test scripts / reports.

J. Lacey

Replimune

Equipment was easy to set up and easy to use. The [OsmoTECH HT] runs reliably and is great to have for running many samples.

Monica G

Biotech

[The OsmoTECH PRO is an] excellent product and extremely efficient! Easy to clean and maintain. Excellent customer support and allows increased in-process testing capabilities.

Seth Rindner

Biologos LLC

The [OsmoTECH PRO] is very easy to use. Allows my lab to update a 20+ year old instrument, also from Advanced.

Walter Wasylenko

Baxter Healthcare Corporation

[The OsmoTECH XT is a] robust and versatile instrument that meets all of our osmolality needs!

Will Heaton

DiscGenics

In the beginning, you never know which kind of samples you’re going to test, and the [OsmoTECH XT] osmometer offers an amazing range of osmolality testing: from 0 to 4000 mOsm/kg H2O.

Kayla Pasake

The Center for Breakthrough Medicines

Osmolality testing is crucial for process development, analytical development and GMP testing. We need to meet the regulatory requirements [with the OsmoTECH XT] for the product to be released to the market or to be released to go to a patient.

Kayla Pasake

The Center for Breakthrough Medicines

The Osmotech XT provides data integrity compliance, ensuring the reliability and accuracy of our results. The ease of use, great value for money, and exceptional after-sales service have significantly improved our processes. The support team is always available for any questions, provided on-site training, and continues to assist with upgrades as needed. I highly recommend this instrument to anyone in the field.

Caitlin Wint

Validation Manager at cutting edge cell therapy developer

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