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Vaccines safety compliance and consistency

Analyzing the concentration and purity of incoming goods and final product formulations for consistency is critical, particularly for certain parameters such as density, refractive index, specific optical rotation, turbidity, and concentration. With our wide range of laboratory instruments, you get the dosage consistency you need, meaning you’ll always have safe and effective vaccines. Our multiparameter analyzing systems comply with major pharmacopeia regulations and help you achieve full traceability.

Learn more about our solutions for vaccine safety, compliance, and dosage consistency below.

Checking concentration of buffers, saline solutions, and other liquid-based materials of vaccines to ensure they are fit for production.

Challenge

With high demand for vaccines during the COVID-19 pandemic, goods for production need to be checked simply and efficiently. Active components as well as excipients like buffers, saline solutions, and similar liquids need to conform to specifications.

Solution

Anton Paar instruments measure specific gravity, viscosity, optical rotation, or refractive index. These are key parameters that determine if goods are suitable for production.

For example: Simply and quickly convert density into concentration, perform fast and easy viscosity determination (single- or multi-point viscosity) and flow curve measurements, determine the molar mass of suspended proteins, or identify a substance by its specific rotation. For all these instruments, take advantage of technological and software features ensuring traceable and compliant measurements. 

Additionally, Pharma qualification packages are available for full documentation. And they reduce time from installation to operation.

Benefits

Benefit from the specific features of the instrument for the task. Enjoy the compact design of the DMA 1001 for simple liquid density measurement. Obtain more parameters per sample thanks to modularity and perform more measurements with the automation options of the DMA 4101|4501|5001.

Use the simplicity of the ViscoQC 300 rotational viscometer. With LOVIS 2000 ME as a module in a density meter, measure density and viscosity simultaneously.

With the Abbemat refractometer family and its unique temperature calibration capabilities, measure refractive index fast and always be sure of the measuring temperature.

With our MCP polarimeters’ best-in-class accuracy, temperature stability, and different data management solutions, making optical rotation measurements is a joy.

For all instruments, take advantage of pharma compliance features including technological functions (depending on the instrument) such as: U-view™, FillingCheck™, viscosity correction, magnetic spindle coupling, and automatic leveling, as well as automatic spindle and guard detection – all of which eliminate erroneous measurements. Furthermore, software solutions including, for example, user management elements, audit trail, and electronic signature secure compliance to regulations like 21 CFR part 11 and traceability. 

Also, instruments are weeks to months quicker in operation with pharma qualification packages and services by Anton Paar.

Key parameters for final quality control, batch release, and dosage consistency

Challenge

There has been a lot of research into new vaccines. This has increased the need for careful analysis of vaccine formulations during all phases of research and production.

To assure a safe and effective product, thorough final quality control and batch release checks have to be performed. Measurements need to be completely traceable and comply with international regulations and guidelines. 

Solution

Anton Paar’s density meters and viscometers are useful quality control instruments for assessing product quality. Additionally, density analysis is a fast and affordable quality control check on final vaccine products to ensure uniformity of dosage prior to packaging.

Benefits

All instruments offer a combination of simple user interface and technological and software features to eliminate erroneous measurements. Aside from technology to guarantee proper filling of the sample cell and accurate viscosity correction, the density meter offers modular extension and automation possibilities. Measurement is according to pharmacopoeia regulation, for example, USP <841>, Pharm.Eu 2.2.5, JP 17 2.56, ChP 2020 (VOL IV) 0601. 

The rotational viscometers offer automatic leveling and recognition of used spindles and guard detection. Measurement is according to USP <912>, Pharm.EU 2.2.10, JP 17 2.53, ChP 2020 (Vol IV 0633).

The LOVIS 2000M rolling ball viscometer profits from low sample volume, accurate temperature control, and possible simultaneous measurement of density and viscosity together when integrated in a density meter. Measurement is according to USP <913>, Pharm.Eu 2.2.49.

Abbemat refractometers measure quickly and only need minimal sample volumes. You can combine them with a density meter to build a modular setup. With the Abbemat, T-Check temperature calibration and adjustment is accurate and simple. Measurement is according to USP <831>, Pharm.Eu 2.2.6., JP 17 2.45, ChP 2020 (VOL IV) 0622.

MCP polarimeters offer long-lasting LED lighting and different wavelengths, while technological features like FillingCheck™ and Toolmaster™ reduce measurement errors to virtually zero. Measurement is according to USP <781>, Pharm.Eu 2.2.7., JP 17 2.49, ChP 2020 (VOL IV) 0621.

All instruments incorporate software features ensuring full compliance and traceability. This means advanced user management, a complete audit trail, and electronic signature and approval processes.

Establishing multiple product parameters & reference values for production or contract manufacturing

Challenge

Large-scale, in-house production or contract manufacturing requires clear reference values for in-process and final quality control.

Testing a variety of multiple formulations must be performed simply and reliably, keeping track of measurement parameters in the research and development phase. Usually, multiple instruments are required to obtain the necessary set of target values and limits to ensure an effective and safe final product.

Solution

Conduct measurements of various parameters of liquids in a simple manner, always keeping track of method parameters and producing cohesive single data sets for each single formulation variant. Typical parameters are density/specific gravity, viscosity, and turbidity.

Single instruments or combined setups with special features and solutions allow for full traceability, pharma–audit trail, user management, electronic signature, etc. Multiparameter measuring system combinations allow you to obtain multiple parameters from a single sample filling.

Benefits

Technical and software features for pharmaceutical applications are built into all relevant Anton Paar instruments: DMA 4101|4501|5001 density meters, Abbemat refractometers, MCP polarimeters, the ViscoQC 300 rotational viscometer, the LOVIS 2000 M/ME rolling-ball viscometer, and the HazeQC ME turbidity module.

The features include: U-view™, FillingCheck™, and viscosity correction for density meters as well as automatic leveling and spindle and guard detection for viscometers.

Polarimeters come with Toolmaster™, and refractometers have a T-Check accessory. These features eliminate erroneous measurements and any manual need for data handling.

The robust Modulyzer Pharma or Modulyzer Turbidity quickly delivers specific multiple parameters from a single sample filling. They have an array of filling possibilities and require minimal sample volume. Temperature control is accurate throughout the complete setup.

The measured parameters like specific gravity, refractive index, and optical rotation are fully compliant with major pharmacopeia regulations – no matter whether an individual instrument or a modular setup.

Anton Paar instruments for pharmaceutical applications provide advanced features for compliance and complete traceability. Other pharma qualification services and documents that are available reduce your time from installation to operation by weeks or even months.

Checking turbidity as an indicator for product contamination

Challenge

Buffers and saline for vaccine production and, of course, the final vaccines have to be checked for turbidity, which is a potential indicator for contamination.

Solution

Reduce risk of contamination of incoming goods and the final product by checking them for turbidity with a multiparameter measuring setup. This is based on a density meter master instrument where you can add further modules like the Haze 3001 turbidity measurement. No separate instrument is needed. 

Benefits

Enjoy the simple handling through the existing, tried-and-tested user interface of Anton Paar’s density meter and measure more critical parameters from a single sample filling.

For the turbidity measurement, there is additional simple handling without scratched measuring cuvettes and calibration of cuvettes. Haze 3001 uses flow-through filling from the master instrument. Furthermore, there are simple check procedures, and there is no need for calibration curves upfront for any measurements.

The pharma compliance features of an Anton Paar density meter as a master instrument and its software solutions secure compliance and traceability for each measurement throughout the complete modular setup. This includes, for example, advanced user management elements, audit trails, and electronic signature.