Designed to meet the high sample throughput, regulatory compliance (including 21 CFR part 11), and data management needs of busy bioprocessing and biomanufacturing labs, the OsmoTECH PRO Multi-Sample Micro-Osmometer combines ease-of-use with accurate and precise osmolality measurements for reliable and reproducible results.
Optimize and ensure the quality and consistency of buffers, media, product, excipients, and process parameters to maximize biologic yield, quality, and purity.
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“Excellent product and extremely efficient! Easy to clean and maintain. Excellent customer support and allows increased in-process testing capabilities.”
“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.”
Maximize biologic yield, quality, and purity by optimizing and ensuring the quality and consistency of your buffers, media, product, excipients, and process parameters.
Maintain efficiency while ensuring product quality and process consistency with osmolality testing from formulation to release.
A 20- position sample turntable enables walk-away testing with intuitive touch-screen interface for easy operation.
Just a 30 μL sample volume is needed, facilitating sample-limited applications.
OsmoTECH PRO utilizes the gold-standard testing method—freezing point depression—to accurately and precisely determine osmolality.
In addition, the instrument now has bi-directional capability with OPC-UA to lab management and middleware software
Get a complete time-stamped record of usage, role, and actions requiring reason for settings changes, as well as the unique ability to annotate test results via the handy comments field.
Active Directory/LDAP options minimize manual input and the risk of errors. Automatic or manual backups, three levels of user access, and an automatic logout timer keep your data safe during idling. Plus, you get unlimited results and events storage
Data integrity features support 21 CFR part 11, GMP and EU Annex 11 compliance guidelines. Also meets Pharmacopeia osmolality testing guidelines.
Using Network Share, USB drive download, the embedded Web server, LIMS for data export and backup.
| Sample type | Aqueous-based solution |
| Sample volume | 30 ± 1 μL |
| Test time | 90 seconds (typical) to test single sample 40 minutes (typical) to test 20 samples |
| Sample Capacity | Multi sample |
| Resolution | 1 mOsm/kg H2O |
| Range | 0-2000 mOsm/kg H2O |
| Accuracy2 | 0-400 mOsm/kg H2O: mean value ± 3 mOsm/kg H2O from nominal value 400-2000 mOsm/kg H2O: mean value ± 0.75% from normal value |
| Within-run Repeatability2 | 0-400 mOsm/kg H2O: standard deviation ≤ 3 mOsm/kg H2O from nominal value 400-2000 mOsm/kg H2O: Coefficient of Variation ≤ 0.75% |
| Temperature effects3 | Less than 1 mOsm/kg H2O per 5°C (9°F) ambient temperature change |
| Calibration | 0*, 50, 850, and 2000* mOsm/kg H2O (* optional) |
| Supported Languages | Simple Chinese, English, French, German, Italian, Japanese, Korean, Russian, Spanish, Turkish |
| Storage temperature | -20°C to +45°C (-4°F to +113°F) |
| Electrical voltage | 100 to 240 VAC (50/60 Hz) |
| Power consumption | 60 Watts |
| Dimensions (D x W x H) | 39 cm x 25 cm x 46 cm (15.3” x 10” x 18”) |
| Net weight | 13.2 kg (29 lbs.) |
| Shipping weight | 17.7 kg (39 lbs.) |
| Warranty | One-year limited warranty on workmanship and parts |
| SK-TECHPRO | Convenience Kit (Includes: 3MA029, 3MA005, 3MA085, 3MA200, 3LA028, 222825, 222840, 202850, 240821) | |
| 3MA029 | Clinitrol™ 290 Reference Solution, 10×2 mL ampules | View |
| 3MA000 | 0 mOsm/kg H2O Calibration Standard, 10×2 mL ampules | View |
| 3MA085 | 850 mOsm/kg H2O Calibration Standard, 10×2 mL ampules | View |
| 3MA200 | 2000 mOsm/kg H2O Calibration Standard, 10×2 mL ampules | View |
| 3LA028 | Osmolality Linearity Set 100-2,000 mOsm 5x2x5 mL | View |
| 222825 | Disposable sample tubes | |
| 222840 | Probe wiper rings | |
| 202850 | Swab Cleaner Kit | |
| 240821 | Sampler Tips, 50/pkg | |
| 135022 | Epson Dot Matrix Printer (sold-separately) | |
| AN2TP5 | Dot Matrix Printer Paper | |
When it comes to process development and manufacturing of protein therapeutics, whether you’re making an antibody-based or other protein therapeutic, what you don’t know can slow you down.
With the innovative osmometers from Advanced Instruments, you can gain valuable data for managing process and product quality through a simple 90-second test. Osmolality, the measurement of total solute concentration, is a reliable control specification and in-process parameter that can deliver information across the protein therapeutic process development and manufacturing workflow.
Optimize cell culture conditions to maximize cell density and yield.
Monitor buffer composition and processes, such as chromatography and filtration, to ensure protein purity and yield.
Monitor and verify the concentration of API and excipients to meet internal quality and regulatory requirements
When the therapeutic you’re developing is cell-based, constant monitoring to optimize growth and ensure consistent culture conditions throughout multiple stages is critical for success.
Using osmolality can help your group answer these questions early in the process, ultimately helping you save time, money, and limited or costly reagents. Adding a simple 90-second osmolality measurement to the in-process parameters you measure is a quick and easy way to ensure optimal cell growth, during process development and manufacturing as well as during buffer and media preparation.
With the innovative osmometers from Advanced Instruments, you can keep delicate cells at optimal growth and gain valuable data for managing process and product quality across the cell therapy process development and manufacturing workflow.
Looking for more information on how osmolality can be an important tool in the formulation of cellular & T-cell based therapies? Check out this in-depth article published on MDPI by a GSK’s R&D group in the UK.
Characterize media and optimize transduction of cells with lentivirus to optimize cell viability and size.
Optimize downstream processing by confirming buffer concentrations and minimizing shock to cells.
Monitor and ensure final composition and manage cryopreservation and storage.
Consistency is critical when producing genetic therapies, including viral vector delivery and gene editing. Small deviations in the composition of cell growth media can have unwanted effects on cell density, cell composition, and virus yield.
Using osmolality can help your group work towards those goals, as well as answer:
With the innovative osmometers from Advanced Instruments, you can gain valuable data for managing process and product quality through a simple 90-second test. When done right, osmolality, the measurement of total solute concentration, is a reliable control specification and in-process parameter that can deliver information across the gene therapy process development and manufacturing workflow.
Looking for more information on how osmolality can be an important tool in supporting QbD in Cell and Gene Therapy manufacturing processes? Check out this in-depth article published by the Alliance for Regenerative Medicine in partnership with NIMBL.
Optimize cell culture conditions and media selection to maximize cell density, size and, ultimately, virus yield.
Check raw material concentration and perform in-process monitoring of purification and filtration steps to maximize purity, cell/virus stability, and yield.
Monitor and ensure final composition, dosage, and stability
Osmolality testing has unlimited applications in areas of personal care and hygiene. Products that come into contact with or penetrate the skin must have an osmolality within a physiological range to avoid damaging cells and tissues. In some instances, slightly hypo- or hyper-osmotic solutions are generated to promote wetting or drying effects. The manufacturing of skincare products, personal lubricants and optical products
One key to a youthful look is healthy and moisturized skin. Proper hydration of skin depends on a balance of water flow into and out of skin cells and, thus, depends on osmolality. Osmolality testing of skincare products provides assurance that the product will have moisturizing effects and serves as a control during the production process.
The osmolality of personal lubricant formulations impacts their effect and safety. The World Health Organization (WHO) stated that the osmolality of these solutions should not exceed 1200 mOsm/kg, with this limit decreasing to a more iso-osmotic level in the future.
Similar value for osmolality testing can be clearly seen in optical applications. Eye drops and other optical products are designed to lubricate or protect the eye. The goal of these solutions (e.g. adding moisture, removing moisture, etc.) dictates an ideal osmolality range.
Osmolality testing is required to ensure that the final vaccine product is safe for administration. The osmolality must be within a physiological range to be introduced in human tissues. There is also evidence that injectable formulations with high osmolality may cause pain at the site of injection.
Vaccines are derived from a variety of sources, both living and synthetic, meaning a variety of bioproduction workflows are required. These workflows include some common use cases for osmolality testing, including the following:
Differentiation in use cases for osmolality testing are outlined below:
Monoclonal Antibody Vaccines
Osmolality testing should be performed on hybridoma cell media to ensure optimal antibody production rates.
Viral Vaccines
Osmolality testing should be performed on media solutions to optimize cell size and viral vector stability.
mRNA and DNA Vaccines
Delivery systems and mechanisms should be tested for osmolality.
COVID-19 vaccine development often falls into these development categories. To better understand how osmolality testing benefits the production of therapies, visit the respective tabs: Protein Therapies, Cell Therapies, Gene Therapies, Oligonucleotides.
An example of an accelerated mRNA vaccine production workflow is below:
This novel field involves the use of antisense oligonucleotides (ASOs), aptamers, siRNAs, miRNAs and synthetic mRNAs to control the expression of genes that have been associated with diseases. Multiple Advanced Instruments customers within this field use osmometers to verify the concentration of the solutions carrying their precious products. Ultimately, the quality of the drug is dependent on the process controls implemented throughout the workflow. Below are some of the current uses for osmolality testing in this field:
Osmolality specifications for buffers to preserve and protect the critical quality attributes of the product as it is being developed.
Compendial release test needed to confirm the identity and concentration of the oligo product for safe use.
Because this is an emerging field, it comes with a number of development and application challenges:
Drug delivery into the target cells requires the proper osmotic pressure, similar to the parameters around viral transfection in vector development. The optimal osmolality of the delivery complex (e.g. mRNA:PEI) should be determined and monitored during this process. This specification will provide repeatable successful delivery of the drug.
All models supportPharmacopeia testing guidelines |
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| Workflow Features | |||||
| Best for labs with daily sample processing needs of: | >20/day | >10/day | 1-10/day | 1-10/day | 1-10/day |
| Sample volume | 40 µL | 30 µL | 20 µL | 20 µL | 250 µL |
| Sample introduction | 96 well plate | Sample cup | One-step direct | One-step direct | Sample cup |
| Operating range (mOsm/kg H2O) | 0 – 2,000 mOsm/kg H2O | 0 – 2,000 mOsm/kg H2O | 0 – 4,000 mOsm/kg H2O | 0 – 2,000 mOsm/kg H2O | 0 – 4,000 |
| Test time (seconds) | 140 | 90 | Less than 150 in low range, Less than 190 in high range | 90 | 120 |
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| Supports 21 CFR Part 11 & EU Annex 11 compliance | |
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| Supports Pharmacopeia testing guidelines compliance | |
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| Username & Password Compatibility (With Active Directory) | |
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| Data Storage Capacity | Unlimited | Unlimited | Unlimited | Unlimited | |
| Levels of users access | 3 Levels | 3 Levels | 3 Levels | 3 Levels | |
| Data Format | .csv & pdf | .csv & pdf | .csv & pdf | .csv & pdf | |
| Part # | OSMOTECHHT | OsmoTECHPRO | OsmoTECHXT | OsmoTECH | 3250 |
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Osmolality as a predictor for model-based real-time monitoring of concentration in protein chromatography
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