Flexible Solutions for Advanced Development and Testing of Fine and Specialty Chemicals
Improve Your Chemical Analysis
Small details make a big difference. For any complex development process - whether a single-chemical entity or a formulation - this can be a major challenge. This is true for development and testing of fine and specialty chemicals where scale, performance or function is the differentiator. When small quantities have a big effect, even the smallest inaccuracies can be significant.
Sartorius understands how important safety, accuracy and reliability are so that your final product meets the highest standards and regulatory requirements. But standard is not enough. You can count on our support in applications across research and development (R&D) and quality control (QC) with premium instruments, consumables and services that simplify and optimize lab workflows, so your finished product has the chemical and physical properties needed. You know your chemistry best.
Our Fine and Specialty Chemical support is applicable across a variety of applications, including:
- Chemical Composition Analysis – Density testing, residue on ignition, moisture determination, etc.
- Sample preparation for wet chemistry, analytical testing and HPLC
- Data Analytics
Applications for Fine & Specialty Chemicals
Chemical Composition Analysis
Simple Analysis to Ensure Performance and Stability
Fine and specialty chemicals are used in a wide variety of applications including paints and coatings, agrochemicals, adhesives, and cleaning products.
Today many customers want chemicals to be produced safely and sustainably with minimal impact on the environment, so they prioritize performance over price. As a scientist, you want to ensure that your fine and specialty chemicals are stable and perform effectively. And, in the case of chemicals used in products such as active pharmaceutical ingredients, food additives and paints they also need to be safe. To do that you need robust, simple-to-use laboratory equipment and protocols which can handle small quantities and low volumes of your specialty chemicals enabling you to reduce waste of any expensive or difficult to manufacture raw materials and end-products in your testing.
These tools help you to generate precise, repeatable results, ensuring your chemicals are manufactured to meet or exceed industry standards including REACH and guidelines such as ASTM, ISO, IP, as well as your customer’s quality specifications.
Applications for Chemical Composition Analysis
Unwanted impurities in fine or specialty chemicals can come from the environment or can be solvents and residual chemicals used or produced during manufacturing. You must sample your specialty chemicals regularly to accurately monitor impurities as they could impact your chemicals’ stability, safety, or performance - making them unsuitable for use in specific industrial applications such as food additives, paints and coatings or active pharmaceutical ingredients.
What to test for:
- Volatile organic compounds
We offer durable products including high quality balances with simple to use software which can produce traceable, reliable results, even with small sample sizes. We also provide pipettes that are accurate down to very low volumes, ultrapure water systems and robust filters. These help you efficiently prepare samples for precise, repeatable impurity testing to rapidly ensure the safety of products, as well as the stability and performance of your specialty chemicals time after time.
Tools for Sample Preparation for Impurity Testing
Cubis® II Ultra-Micro | Micro & High-capacity Micro Balances
Organic impurities can arise during the manufacturing process and/or storage of a product. Sample preparation is a key step used to identify these process-related impurities.
Cubis® II Premium ultra-micro | micro and high-capacity micro balances are ideal for sample preparation for analytical applications that require very small sample quantities (e.g., elemental analysis). Cubis® II ultra-micro | micro and high-capacity micro balances are the laboratory balances with fully customizable hardware, software, and connectivity. These design elements guarantee a higher degree of adaptability for different workflows, whilst the gesture sensors lower the probability of contamination and reduce human interference during measurement.
Additional features include:
- Modern user interfaces with ergonomic sample handling and easy process integration
- Pharmaceutical and GxP compliance (including data handling, data integrity and connectivity)
- High accuracy and precision
Best models in this application are the MCA2.7S, MCA10.6S, MCA36S, MCA66S or MCA116S.
Cubis® II Configurator: Your Custom Balance in 4 Easy Steps - Configure Now
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In many fine or specialty chemicals, moisture can lead to microbial contamination which can cause for example spoilage of paints and coatings to produce bubbling and eventual cracking of the paint. You must check moisture content to ensure it is within industry accepted levels before filling or packaging and shipment to maintain the performance and stability of your chemicals.
What to test for:
Moisture determination of incoming raw materials
Moisture analysis of your finished chemicals
We offer a robust range of precision engineered products including moisture analyzers and balances, designed to work with even small sample sizes, acknowledged in the industry for their quality and ability to consistently generate precise results. This helps you accurately detect moisture in your raw materials and finished ingredients, ensuring your fine and specialty chemicals are effective and of the right specification when they reach your customers.
Tools for Moisture Determination
MA160 Moisture Analyzer
Understanding and maintaining the correct moisture content of a product is essential during manufacturing, as well as in research and development and testing laboratories. In a quality control environment, standard moisture testing approaches can be time-consuming, causing delays in production and in facilities that process a number of different kinds of samples, it can be challenging. By using a moisture analyzer you can overcome these bottlenecks and achieve results comparable to your standard method in minimal time.
The MA160 moisture analyzer is designed for quick and reliable moisture testing of a variety of samples, including liquids, pastes, and solids. It accommodates changing requirements by enabling you to use specific methods and efficiently manage all parameters.
Additional features include:
- Enhanced repeatability and balance
- A durable design that withstands heat and harsh environments
- Optimal weighing mechanism (no battery necessary)
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The types of particles in your fine and specialty chemicals can affect product performance. For example, particle size and distribution can affect the finish of coatings in aerosols sprays such that these can produce an undesired matt or glossy appearance. Active pharmaceutical ingredients (APIs) are analyzed and tested in this regard to be within specifications to ensure performance, for example relating to their dissolution behavior, which can not only have an effect on processing the product but more importantly on the API’s efficacy in its final dosage form.
What to test for:
Average particle size
Size distribution
Shape, morphology
We offer products including robust filters to help you precisely sample your particles for accurate analysis, allowing your specialty chemicals to meet your customer’s demanding quality and performance expectations.
Tools for Particulate Matter Analysis
Cubis® II Ultra-Micro | Micro & High-capacity Micro Balances
Particulate matter is an amalgamation of different particles. These can be solid and/or liquid and be of various sizes (from a few nanometers to ~ 100 micrometers). The human or natural-made matter consists of components released directly from the source into the atmosphere (primary) and components that are formed in the atmosphere by chemical reactions (secondary). Particulate matter is a complex and significant health threat, therefore, monitoring and analysis is required for regulatory purposes.
Cubis® II ultra-micro | micro and high-capacity micro balances with specific sample holders for filters.
The Cubis® range of premium balances are designed for high performance weighing. Cubis® II ultra-micro and micro balance MCA2.7S and MCA10.6S can be used in combination with the respective QApp (a pre-installed customer-specific application package) and the draft shield F – a manual stainless steel draft shield designed for filter weighing –providing protection against drafts and electrostatic charges to achieve accurate weighing of filters. Cubis® II high-capacity micro balances are an alternative with outer and inner (recommended) glass draft shield and integrated licensable ionizer. The glasses are coated with a conductive layer to lead away electrostatic charges from the draft shield interior. The ionizer is used to eliminate remaining electrostatic charges on the filters and tools.
Addition features include:
- Configurable balance with different filter holders made of Titanium (50 mm, 75 mm and 90 mm for ultra-micro and micro balances or 75 mm and 150 mm for high-capacity micro balances)
- Proximity sensor for touch-free operation of high-capacity micro balances
- Manual or automatic inner draft shield for Cubis II MCA36S, MCA66S or MCA116S
Cubis® II Configurator: Your Custom Balance in 4 Easy Steps - Configure Now
Octet® BLI in Nanoparticle Research
The Octet® BLI platform can serve as an invaluable tool in nanoparticle (NP) development. It provides several measurable NP quality attributes, including binding affinity, kinetics and stability.
Octet®️ BLI systems do not utilize microfluidics. Samples get measured in microtiter plates and are non-destructive. This is in sharp contrast to surface plasmon resonance (SPR) biosensor systems. A greater flexibility in samples types includes cell lysates or aggregation-prone formulations. The size of the analyte does not affect the measurement either. Hence Octet® BLI systems are an attractive solution for nanoparticles-based biological agent development.
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Knowing the density of your fine and specialty chemicals will help you determine product purity and calculate your fill volume, as well as product formulation. Density measurements are commonly used to check the quality of custom water-based muds used in oil and gas exploration, specialty plastics used in applications such as sheeting and pipe construction, as well as the quality of paints and inks.
What to test for:
Density of solids
Density of liquids
Density with pycnometer
We have robust products including pycnometers for use with a specific range of balances with simple to use software for density applications. These help you rapidly and reproducibly calculate the density of your liquid or powdered chemicals.
Tools for Density Testing
Cubis® II analytical & semi-microbalance (Cubis II with Q-App) MCA (package with back-weighing program, QP2 package)
A pycnometer is used to determine the density of a paste or powder. The method relies on the use of a reference liquid with a known density (such as water). The density of the sample is calculated from the difference in weight due to the displacement of the reference liquid.
For density testing of solid samples, a density determination kit can be used. The solid sample is placed on a weighing pan to determine its weight in air, before being submersed in a test liquid. The density of the solid is then calculated and automatically corrected for influencing factors.
Additional features include:
- Ability to test the density of solids, liquids and pastes
- Density determination kit for semi-micro and analytical balances (YDK03MS) or precision balances (YDK04MS)
Cubis® II Configurator: Your Custom Balance in 4 Easy Steps - Configure Now
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Inorganic impurities in fine and specialty chemicals can come from the environment or can be produced during the manufacturing process. You must sample your chemicals using a residue on ignition test, also known as a sulphated ash test, to determine the percentage of inorganic impurities. If the amount of these impurities is too high, they could affect the performance or quality of your specialty chemicals and where the chemicals are used in paints for example, they can affect your product’s safety profile.
What to test for:
Production reagents
Inorganic salts
Heavy metals such as lead, chromium and mercury
We have quality products including ashless filters and durable, easy-to-clean balances with simple to use software for residue on ignition applications which can generate reliable results with even small sample sizes. These help you reproducibly calculate the percentage of inorganic impurities in your specialty chemicals to ensure they are the right quality and safety specifications for your customer’s applications.
Tools for Residue on Ignition
Cubis® II analytical & semi-microbalance (Cubis® II incl Q-App); QP2 package
Residue on ignition is an important analysis for ensuring that products are not only safe and effective, but consistent between batches and manufacturers. The residue on ignition test describes the method used to measure the quantity of residual substances that are not volatilized from a sample once it has been ignited in the presence of sulfuric acid. Samples are subjected to heat treatment in a drying oven under the influence of oxygen which destroys organic substances.
The loss of mass (i.e., loss on ignition) represents the organic portion of the sample while the residual ash (i.e., residue on ignition) represents the inorganic portion. The software application residue on ignition (QAPP209) helps users determine initial weight, back weight and residue on ignition in compliance with DIN EN ISO 3451-1, DIN 18128, DIN EN 12879, DIN 19684-3, DIN EN ISO 1172, DIN EN 1879, DIN 38409-2, DIN 38409-1, USP Chapter 42 <281> and European Pharmacopoeia (PhEur) chapter 2.4.14.
Additional features include:
- Software application Residue on ignition with guided workflow
- Elimination of electrostatic charges on samples and tools by built-in ionizer (draft shield version I) or external ionizer (accessory) possible
- Glass draft shield I, A, or U with conductive coating to lead away electrostatic charges from the draft shield interior
Cubis® II Configurator: Your Custom Balance in 4 Easy Steps - Configure Now
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You need to monitor the quality of the water that goes into manufacturing your fine and specialty chemicals, as well as the wastewater it produces. Fine and specialty chemicals often need processing or treatment with good quality water to remove impurities and many substances in your wastewater from chemical production can cause major damage to the environment if they enter water ways in high concentrations.
What to test for:
pH
Heavy Metals
We have durable, simple to use products including precise pipettes that can handle low volumes, specific filters, and robust pH meters to help you sample and analyze your process and wastewater to ensure it maintains its safety profile to meet industry guidelines time after time.
Tools for Process & Ground and Waste Water Analysis
Sartolab® P20 Pressure Filters
Water and wastewater analysis is key to ensuring quality control standards are met and upheld. Groundwater is a drinking water source and consequently must be monitored closely to confirm its suitability for consumption. Unfortunately, groundwater can become contaminated with heavy metals from landfill and industrial site wastewater. Continuous monitoring of the wastewater emerging from these sites enables the detection of potential contaminates that may be leached into the surrounding groundwater, compromising its quality and safety.
The Sartolab® P20 pressure filter is a unit which can be used for sterile filtration or clarification of media, solvent mixtures, and aqueous solutions. The filters can process batches up to 10 L at a time.
These pressure filters can help workflows to detect heavy metals heavy metals and chlorine in water.
Other benefits include:
- Highest flow rates with a large surface of filtration (20 cm²)
- Version available with a prefilter for particle-high-loaded solutions
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Sample Preparation for Analytical Testing
Accurately Measuring and Monitoring Product Quality
To ensure your fine and specialty chemicals meet the highest stability and efficacy standards, you need to perform analytical testing on your incoming raw ingredients, during intermediate production steps, as well as before final release. This helps you determine the levels of impurities and potentially toxic or hazardous compounds that may be present.
Applications for Analytical Testing
Whether in starting materials or processed products, inappropriate levels of undesirable compounds in your fine and specialty chemicals can make them unstable and can affect performance. In some applications they can render chemicals unsafe, for example high levels of chromium in paints can cause toxicity problems. With reliable sample prep methods and accurate analytical tools, you can detect and monitor the levels of these compounds in your fine and specialty chemicals to ensure they meet your rigorous QA requirements for impurity testing.
Great samples start with pure water and we provide robust water purification systems for producing ultrapure water for buffer and sample preparation. We also offer pipettes, designed for accurate low volume sampling and precise balances with easy-to-use software. This combination of trusted sample preparation tools can be used in an integrated workflow to help you get accurate, traceable results from your analysis, and deliver stable, effective specialty chemicals.
Sartorius Solutions for HPLC
HPLC Sample Preparation
High performance liquid chromatography (HPLC) is a highly precise, reproducible, and specific analytical method. For optimal results, a sample must be dissolved in the correct solvent and free of particles to reduce interference and prevent blockage of the HPLC column. As a result, of this labor-intensive sample preparation step, the protocol is considerably time-consuming.
Using Sartorius’ products during sample preparation, you can overcome these challenges, save time, and increase the reproducibility of your results. Additional benefits include:
- Higher accuracy and sensitivity
- No blockage and or leachables
- Reduced background noise and false-positive peaks
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Sometimes your fine and specialty chemicals are used in a liquid form, so you must test their stability and performance in solution to ensure they meet quality specifications. For example, if a paint viscosity is too lower it can indicate possible contamination or degradation, all of which will affect your customer’s product performance.
What to test for:
Color
pH
Viscosity
We provide user-friendly, compact water purification systems for producing ultrapure water for high quality aqueous sample preparation where and when it is needed. We also offer pipettes for accurate low volume sampling and balances with software which is simple to use and generates reliable results. These trusted sample preparation tools help you rapidly produce the best solutions of your specialty chemicals for testing every time.
Tools to Support Wet Chemistry
Cubis® MSA dosing system
Reference samples, also known as standards, are used to determine the concentration of chemical compounds using highly sensitive quantitative analytical procedures. These standards have a defined concentration of one or several known compounds which must be as accurate as possible to prevent subsequent errors when determining unknown sample concentrations.
The Cubis® MSA dosing system simplifies workflows in the preparation of analytical standards. Using the special QApp software, the solvent volume is automatically corrected to the appropriate value, eliminating the need to reach the precise target weight. At the end of the procedure, the weight of the compound and solvent is used to calculate the verified concentration and volume of the standard prepared.
In addition to providing valid and flexible results, other features include:
- Integrated system with software application and automatic preparation of standards
- Standardized process (100% compliant with SOPs) with controlled and consistent workflows
- Automated processes that are cost- and time-efficient
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Microbiological Testing
Managing Your Microbes
To minimize contamination risks with your fine and specialty chemicals you need to know which microorganisms could be lurking in your water, production, filling, and packaging areas. Introducing microbes at any stage in your process may cause changes in viscosity for example with paints, or spoilage, and degradation, leading to poor quality. The result could be unstable, ineffective, or even unsafe product.
Applications for Microbiological Testing
Microbes in your process water can contaminate your fine and specialty chemicals making them unstable or perform poorly. For example, with paints biocides are used less frequently as consumers want safer products, but this means paints are more susceptible to microbial contamination which can cause paint bubbling or paint that produces unpleasant odors. To avoid these issues, process hygiene when producing fine and specialty chemicals for paints is more important than ever. To monitor your process water, you must undertake regular water tests and decontaminate your water systems if high levels of microbes are present.
What to test for:
- Total Count of Aerobic Microbes (Bacteria and Fungi)
We have high-quality products including robust membrane filtration systems, as well as media and label-free biosensor technologies for safe and efficient detection of microorganisms in your process water. These enable you to generate accurate, reproducible results and help you meet industry standards with microbial testing of your specialty chemicals.
Tools for Membrane Filtration
Microsart® Manifold
Bioburden testing is used to measure levels of microbial contamination in a sample. Microbial contamination can cause incorrect results, unproductive workflows and ultimately results in poor product quality and stability. Therefore, quality control laboratories need to achieve accurate detection and quantification of microorganisms in liquid samples (such as those from water systems).
The Microsart® Manifold is an instrument for membrane filtration which provides reliable and reproductible results. This product allows the consumer to select the correct manifolds to suit the needs of individual microbiological testing workflows. For example, reusable or single use funnels/ filtration units and various sized manifolds.
Additional benefits include:
- 100% stainless steel for easy cleaning, full autoclavability without disassembly
- Low height for ergonomic working in laminar flow
- Quick connection adaptors for fast assembly of tubing and manifolds
Octet® Systems for Bacterial Pathogen & Endotoxin Detection
The high-throughput Octet® instruments provide a simple, quick and sensitive platform for the detection of E. coli and other bacterial contaminants label-free. The microfluidic-free sensor design makes it highly suitable for on-site real time detection of pathogens and other contaminants. In addition, the Sartorius Octet® N1 instrument is a miniaturized version of the Octet®, allowing for easy portability of the technology.
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Microbial contamination can be present in your raw materials or could be introduced during production. Although microbes are often present in low numbers in many fine and specialty chemicals, if contaminated water is present in food additives or paints for example, this can lead to microbial contamination and product degradation. This type of contamination can shake your customer ‘s confidence in your brand and may have a financial impact on your company. Your fine and specialty chemicals are not expected to be microbe-free, but they must be within the limits defined for potential spoilage organisms.
What to test for:
- Total Count of Aerobic Microbes (Bacteria and Fungi)
- Specific spoilage bacteria such as Flavobacterium
- Specific spoilage molds such as Penicillium
Adhering to a regular sampling plan with in-process controls along the entire production chain from raw materials through to finished chemicals you can easily detect unwanted microbes. Our products for microbial testing such as filters, pumps and manifolds can help capture the smallest microorganisms for analysis. We also provide media and label-free biosensor technologies for efficient, accurate detection of potential spoilage microorganisms to help you meet industry standards with your microbial limits testing.
Tools for Microbial Limits Testing
Microsart® @filter
Microbial limit testing is designed to investigate the quantity and identification of microorganisms present on raw materials, in-process samples and finished products. These tests are needed to confirm the safety of a product or sample, specifically if quantitative limits of certain microorganisms are exceeded, for example Escherichia coli, Staphylococcus aureus or Salmonella.
The Microsart® @filter combines a funnel, filter base and a gridded membrane filter in one unit. This filter unit can detect microorganisms in raw materials, in-process samples and final products across numerous industries including pharmaceutical, cosmetic and personal care. As per USP <61>, membrane filtration is a viable method for detection of microorganisms within your sample.
Key benefits include:
- Ready-to-use sterile filtration devices
- Reliable results as no liquid remains after filtration
- Transparent funnel material allows the filtration process to be visible
Octet® Systems in Formulations & Aggregation Studies
Octet® platforms give you the capability for multiple applications in one system. It enables critical functional stability studies, where the presence of aggregation can be monitored in tandem with more traditional binding analysis such as target binding, potentially saving some users the need for multiple technologies.
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Introducing microbes at any stage in your production, filling and packaging process may cause changes in viscosity in paints and coatings for example, as well as oxidation, and degradation leading to poor quality chemicals which may be unstable or ineffective for their application. Good process hygiene is essential, especially where your fine and specialty chemicals are going to be used as the basis for active pharmaceutical ingredients or food additives and part of that is knowing which microorganisms are in the air in your production, filling and packaging areas to minimize contamination risks.
What to test for:
- Test for airborne microorganisms at critical points in your production, filling and packaging areas.
Based on the membrane filtration method, our unique gelatin filters coupled with our air monitoring systems can retain even the smallest microbes. This sampling system can accurately detect potentially damaging microorganisms and allowing you to act quickly to remove high levels of contamination in your processing areas.
Tools for Air Monitoring
MD8 Airport
Clean rooms and critical zones are essential for research and development in pharmaceutical, biotechnology, food and beverage, and microbiology settings. It is essential that these areas are kept free of any contaminants, such as airborne particles. The presence of these particles must be continuously monitored and kept to a minimum – this can be achieved with accurate and reliable air monitoring systems.
The MD8 Airscan and the portable AirPort MD8 air samplers are designed to detect airborne viruses and microorganisms. Sampling can be conducted isokinetically using the MD8 Airscan. MD8 air samplers, paired with the unique Gelatine Membrane Filters (GMF) and BACTairTM agar plates, facilitate routine monitoring of airborne microbes and viruses enabling timely detection of critical situations.
Key benefits include:
- Portable system which is battery-powered
- Sample volume and volume flow can be adjusted
- Easy to clean and comes in an ergonomic design
Data Analytics
Optimize Raw Material Selection, Processes and Control
In industries that manufacture complex chemicals, finding ways to optimize quality, reduce waste and improve inefficiencies often hinges on selecting the right chemical compounds or optimizing production processes. Data analytics software can improve this effort at every stage: research, development and manufacturing.
The Umetrics® Suite of data analytics tools can help you find alternative compounds that meet complex requirements, decrease raw material usage or enable more cost-effective, sustainable manufacturing procedures.
The Umetrics® software can also help you monitor production in real-time, particularly batch processes, preventing waste and quality concerns.
When it comes to evaluating the chemical properties of a compound, data analytics streamlines the process. MODDE® Design of Experiments (DOE) software lets you select a small set of diverse and representative compounds for testing. This allows you to predict the properties of untested compounds based on the properties tested and reduces the number of experiments you need to do to find the most promising product for your purposes, saving time and money.
The SIMCA® Multivariate Data Analysis software uses principal component analysis (PCA) and other methods like partial least squares (PLS) or our proprietary orthogonal PLS (OPLS) to visualize data, providing reliable, data-backed guidance to adjust production processes in order to use raw materials more efficiently, increase output, maintain quality, and reduce wear and tear on equipment.
One of the most effective ways to ensure your processes stay under control and meet their critical quality attributes is with real-time process monitoring. Being able to take corrective action immediately helps reduce waste (lost batches) and increase yield. With SIMCA®-online, you’ll gain confidence in your production processes and achieve more consistent product quality.
Integrating laboratory instruments into your IT environment is a crucial task when it comes to the digitalization of both R&D and QC laboratories to increase operational efficiency, data integrity and the use of data analytic tools.
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Service & Support
There When You Need Us
We offer a global network of service and support, with trained experts and scientists to help you. This means we can assist you with servicing, calibration, technical questions, software updates and repairs as and when you need them, allowing you to minimize downtime and keep testing your fine and specialty chemicals to ensure they are stable, perform effectively and are safe for use in specific applications.
