3250 Single-Sample Osmometer
The 3250 Single-Sample Osmometer is designed for routine osmolality measurement in pharma, biotech, and food and beverage labs. Providing accurate and precise osmolality measurement, the 3250 combines proven freezing point technology with the versatility of advanced sample processing capabilities in an osmometer that is both simple to operate and easy to maintain.
- Single-sample osmometer
- Wide operating range of 0-4000 mOsm
- Gold-standard freezing point technology
- Meets Pharmacopeia osmolality testing guidelines
IN BIOTECH LABS
Maximize biologic yield, quality, and purity by optimizing and ensuring the quality and consistency of your buffers, media, product, excipients, and process parameters.
IN FOOD & BEVERAGE LABS
Maintain efficiency while ensuring product quality and process consistency with osmolality testing from formulation to release.
GOLD STANDARD PERFORMANCE
EASY TO USE
WIDE OPERATING RANGE
FLEXIBLE REPORTING OPTIONS
BACKED BY COMPREHENSIVE SUPPORT
|Sample test volume||200 to 250μL|
|Test time||Low range: 2 minutes (approximate)|
High range: 3 minutes (approximate)
|Sample capacity||single sample|
|Resolution||1 mOsm/kg H2O|
|Range||Low range: 0 to 2000 mOsm/kg H2O|
High range: 0 to 4000 mOsm/kg H2O
|Linearity||less than ±0.5% from a straight line over calibrated range|
|Repeatability||standard deviation ≤ 2 mOsm/kg H2O between 0 to 400 mOsm/kg H2O; standard deviation ≤ 0.5% of value between 400 to 4000 mOsm/kg H2O|
|Drift||Less than 1 mOsm/kg H2O per month|
|Temperature effects1||Less than 1 mOsm/kg H2O per 5°C (9°F) ambient temperature change|
|Calibration||• Low range: 0*, 100 and 1500 mOsm/kg H₂O (* optional)|
• High range: 1500 and 3000 mOsm/kg H₂O
|Communication||Onbord printer, DTE RS-232 Serial Port and optional bar code scanner|
|Support Languages||English, French, German, Spanish, Italian, Portuguese, Swedish, Danish, Turkish, Czech, Slovak|
|Storage temperature||-40°C to +45°C (-40°F to +113°F)|
|Electrical voltage||100 to 240 VAC (50/60 Hz)|
|Dimensions (D x W x H)||16″ H x 13″ W x 18″ D (40.6 cm x 33.0 cm x 45.7 cm)|
|Net weight||23.0 lb (10.4 kg)|
|Shipping weight||34.0 lb (15.4 kg)|
|Warranty||One-year limited warranty on workmanship and all parts except glass, plastic, and part warrantied by their makers|
|*operating condition -18°C to 35°C (64°F to 95°F); 5% to 80% relative humidity (noncondensing)|
*specifications subject to change
Osmometer Calibration Standards and Reference Solutions
|SK-3250 Biotech||Convenience Kit (Includes: 3LA825, 3DA811, 3LA029, 3LA151, 3LA301, 3LA028, FLA835, 3LA011)|
|SKC-3250 Clinical||Convenience Kit (Includes: 3LA825, 3DA811, 3LA029, 3LA151, 3LA301, 3LA028, FLA835, 3LA011, 3MA028, 3LA085)|
|3LA011||100 mOsm Calibration Standard, 10×5 mL Ampules||View|
|3LA029||Clinitrol™ 290 Reference Solution, 10×5 mL Ampules||View|
|3LA091||900 mOsm Calibration Standard, 10×5 mL Ampules||View|
|3LA151||1500 mOsm Calibration Standard, 10×5 mL||View|
|3LA301||3000 mOsm Calibration Standard, 10×5 mL Ampules||View|
|3LA028||Osmolality Linearity Set 100-2,000 mOsm 5x2x5 mL||View|
Osmometer Control Solutions
Supplies & Accessories
|3LA825||Sample Tube, Plastic, Box 500|
|3DA811||Heat Transfer Fluid, 1×150 mL|
|3D2340||Air Filters, Disposable, 6/pkg|
|3LA846||30 Sample Tube Rack|
|FLA835||Thermal Printer Paper, 5 rolls|
Get the best performance from your osmometer from the people who designed and built it. We provide a range of services and service plans to meet the different needs of our customers. Our certified Field Service Engineers provide on-site professional support for the installation, training, validation, and maintenance of your osmometers.
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.
- Are all of your buffers and media formulated correctly?
- Does your solution have unexpected components?
- Are all of the steps involving solutions–i.e. cell growth, dialysis, chromatography–proceeding consistently and as expected?
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.
Cell Line Development
Cell Culture Monitoring
Monitor buffer composition and processes, such as chromatography and filtration, to ensure protein purity and yield.
Fill & Finish
Monitor and verify the concentration of API and excipients to meet internal quality and regulatory requirements
Filtration and Fill
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.
- Are your stem cells at highest viability and product quality levels throughout culture and passaging?
- Are you ensuring a high rate of cell recovery post-thaw?
- Are your transduction mechanics being optimized?
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.
Characterize media and optimize transduction of cells with lentivirus to optimize cell viability and size.
Cell Line Development
Cell Culture Monitoring
Optimize downstream processing by confirming buffer concentrations and minimizing shock to cells.
Fill & Finish
Monitor and ensure final composition and manage cryopreservation and storage.
Formulation and Fill
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.
- Are you looking for ways to increase vector stability?
- Is your gene therapy group looking for higher transfection efficiency and higher viral vector production?
Using osmolality can help your group work towards those goals, as well as answer:
- how to optimize the physiological range for transfection complexes
- identifying media needs
- determining effects of osmotic pressure on the stability of a complex
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.
Optimize cell culture conditions and media selection to maximize cell density, size and, ultimately, virus yield.
Cell Line Development
Cell Culture Monitoring
Check raw material concentration and perform in-process monitoring of purification and filtration steps to maximize purity, cell/virus stability, and yield.
Fill & Finish
Monitor and ensure final composition, dosage, and stability
Filtration and Fill
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:
- Upstream cell culture and/or cell expansion requires maintaining an environment at the appropriate osmolality for the specific cell type. For those modalities that are cell-based, regular osmolality testing will ensure that the media and environment are optimized.
- Buffers used during any downstream processing should be tested for osmolality to verify the concentrations of the solutions that are meant to protect the drug substance throughout the chromatography and/or filtration operations.
- Final product testing must include osmolality to verify identify and safety of any injectable.
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.
- The rate of antibody production in hybridoma cells depends on the osmolality of the medium in which the cells are grown.
- The osmotic agent used to affect the osmolality levels also impacts Ab production.
Osmolality testing should be performed on media solutions to optimize cell size and viral vector stability.
- Osmotic pressure affects the size of the morphology of insect cells and viruses.
- The osmolality of the media affects the composition of the lipid bilayer membrane of enveloped viruses. This directly impacts the vector stability.
mRNA and DNA Vaccines
Delivery systems and mechanisms should be tested for osmolality.
- mRNA can be complexed with different agents (e.g. PEI) for delivery within the body. Osmolality impacts the stability of the complex of viral models.
- Osmolality impacts the ability to penetrate the target cell membrane.
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:
(as little as 1 year)
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:
- Delivery of RNAs across the lipid bilayer and into cells
- Immunogenicity once in the body
- High rates of degradation of oligos by plasma and tissues
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 support
Pharmacopeia testing guidelines
Being discontinued Dec. 31, 2020
|Best for labs with daily sample processing needs of:||>10/day||>10/day||1-10/day||1-10/day||1-10/day|
|Sample volume||100 µL||30 µL||20 µL||20 µL||250 µL|
|Sample introduction||Automated liquid handling sample cup (automated)||Sample cup||One-step direct||One-step direct||Sample cup|
|Operating range (mOsm/kg H2O)||0 – 4,000||0 – 2,000||0 – 4,000||0 – 2,000||0 – 4,000|
|Test time (seconds)||180||90||Less than 150 in low range, Less than 180 in high range||90||120|
|Compliance Support Features|
|Supports 21 CFR Part 11 & EU Annex 11 compliance|
|Supports Pharmacopeia testing guidelines compliance|
|Integrated barcode scanner|
|Multi-language touchscreen display|
|User name & password compatibility|
|Automated cleaning between samples|
|Automated sample pipetting|
|Temperature control method||Dry cooling (No heat transfer fluid)||Dry cooling (No heat transfer fluid)||Dry cooling (No heat transfer fluid)||Dry cooling (No heat transfer fluid)||Heat-transfer fluid|
|Data Management Features|
|OPC-UA, Network share,|
|DTE RS-232, Barcode port|
|Download Chart as a PDF||Learn More|