Formulation development is the process in which a variety of different substances are combined in precise proportions to create a specific product. The proportions of the various substances mixed together in the formulation recipe are determined in the formulation development process. The formulation development process involves repeated experimentation with the ingredient substances to achieve the desired characteristics in the final product: e.g. taste, color, shelf-life, performance, or effectiveness.
Formulation development is highly dependent upon weighing the ingredients accurately. If one step in the weighing process is wrong, the scientist is required to go through the tedious recalculation and adjustment of the other ingredients to make the correction. If this mistake goes unnoticed, products may have different properties or be out-of-specification, resulting in waste, costly reworking or may even pose a risk to the health of the end consumer, particularly in the pharmaceutical and food industries.
Developing the right formulation in the laboratory is a time and labor-intensive process and the different industries are faced with a variety of challenges such as:
Watch the video and see how XPR balances can save you time and money when preparing formulations thanks to customizable methods, SOP user guidance, automatic calculations and the built-in results notepad.
In a formulation, ingredients are typically added one by one to the selected container. The capacity of the balance must be large enough to accommodate the sum of all ingredients plus the container. Depending on the accuracy and capacity required, the use of two different balances may be necessary.
Formulation development requires accurate execution of the formulation recipe to ensure safe, high-quality products. Selection of the right balance to meet the formulation accuracy requirements is vital, as is ensuring that weighing always takes place in the safe weighing range of the balance. To determine the safe weighing range, the balance's minimum weight must be determined.
If you need support or advice on whether your balance meets the needs of your formulation applications, please don't hesitate to contact us.
| Industry / Workplace | Formulation Description | Targeted Improvement |
| Pharmaceuticals | Combination of active pharmaceutical ingredient (API) with various inert ingredients (excipients) which allow to bring the drug into a form it can be administered to the patient. Possible forms may be tablet, capsule, inhaler or intravenously. |
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| Cosmetics / Flavor & Fragrance | Flavors or cosmetics are delicate combinations of 50 or more substances which need to be combined in an accurate manner. Differences in its formulation might result in difference in flavor. |
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| Chemicals / Petrochemicals | Large variety of products such as i.e. oils, paints, glues and lacquers. Such products often contain highly volatile or toxic substances. | Strongly depending on the product developed. In case of an oil it might be physical properties such as:
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| Food & Beverages | Development of new products due to market demands. Development of new flavors, product with different texture at optimized costing. |
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Different industries are addressing a variety of different goal by developing their formulations. The table above provides information on how formulations look like in the different industries and what the individual goals are.
Typical sources of error in any weighing process include: Lack of weighing tolerances, use of inappropriate instrumentation, sample spills, temperature variations, air drafts, documentation errors and insufficient scientist skills. As formulation processes involve multiple weighing steps, the combined errors can become significant.
Product Consistency
Every formulation is developed to meet certain criteria, whether it be taste, color, or drug dosage. Without consistency in the formulation, the product will fail to meet expectations, leading to dissatisfied customers, and may even pose a risk to health and/or safety. It is therefore essential to ensure that the weight of each formulation ingredient meets the process tolerances defined in the formulation SOP. The balance used must be able to fulfil the desired process accuracy requirements and should have appropriate quality assurance measures in place to ensure this.
Recipe Complexity
Cosmetics formulations often consist of 50-100 different components, requiring a great deal of effort and concentration from the analyst. Overdosing just one component requires recalculations and adjustments to be made to the ingredients, or the entire formulation must be started again from scratch. The risk of an error occurring can be significantly reduced if the formulation workflow includes steps for the scientist to confirm:
Accurate Weighing of Critical Components
For small quantities of critical or expensive ingredients, it may be necessary to use a second balance with a higher readability and greater accuracy, particularly where there is a large difference between the individual ingredient amounts and the total target mass. Having two balances occupies more lab space, creates extra steps in the workflow, increases the process uncertainties and necessitates a higher investment.
Documentation
To ensure traceability, formulation documentation typically includes formulation ID, substance ID, target mass, tolerances, and actual amount dosed, as well as basic information such as date, time, and user ID. Any recalculations and adjustments must also be documented. Manual recording of all this information carries a huge risk of human error. If there is any mistake in the formulation, it may be impossible to find the source of the error if the data has been recorded incorrectly.
METTLER TOLEDO XPR precision balances provide you with fast and accurate formulations, even under the toughest weighing conditions, both in the lab or out on the factory floor. Smart quality assurance features, such as StatusLight™, LevelControl and GWP Approved help ensure right-first-time results.
Save your formulation methods on the balance
The built-in formulation application can be tailored to your specific formulations. You can save your customized formulation methods in the method library. The intelligent methods recalculate ingredient amounts automatically depending on the total quantity you want to prepare.
Efficient weighing and documentation
The high stability provided by the unique SmartPan™ weighing pan means you get your results up to twice as fast compared to a standard weighing pan. You can connect a barcode scanner to read in substance IDs quickly and without error. Results and task data are automatically recorded on the built-in results protocol, eliminating time-consuming and error-prone manual data input/output. Multiple interfaces (4 USB, 1 LAN) make it easy to export results to a PC or other system.
Higher Performance Balances
For high accuracy demands, METTLER TOLEDO's higher performance balances are perfect when there is a low net sample weight and a requirement for exceptional repeatability. These higher performance balances enable users to weigh small ingredient quantities with a unique level of precision while still having the capacity to weigh all formulation components on one balance. The need for two separate balances is eliminated.
Comprehensive data management
Connect your XPR balance to LabX laboratory software for comprehensive data management and full traceability. The solution can be integrated with your company's existing ERP/LIMS system, enabling bi-directional transfer of recipes and results. LabX takes care of all process information and calculations automatically. All data is saved securely in a centralized database and reports can be generated at any time. Instruments, tasks and users can all be managed centrally. For highly regulated environments, LabX helps with compliance with FDA ALCOA++ data integrity requirements.
Alternative Solution for Formulation: MX and MR Balances
METTLER TOLEDO's advanced level balances offer an alternative solution for formulation applications, by addressing the challenges faced during sample handling and final documentation.
The MX and MR balances feature a built-in formulation application which provides step-by-step guidance through the whole formulation process. The recipe code and the ingredient IDs can be entered quickly, and without error, by using barcodes. The application automatically records each weight value and zeros the balance in between the addition of each ingredient. At any time, it's possible to view the ingredients added, and their weight values. Once the recipe is complete, the whole formulation can be published across multiple data management options to ensure proper storage of the data.
Thanks to these various data management options, error-free transfer of your weighing data is fast and simple. Additionally, MT-SICS commands enable seamless integration of your balance with existing formulation systems, ensuring smooth communication and streamlined processes.
In the development of a new product, formulation is used on a small scale to create the perfect formulation recipe. For manufacturing, the formulation is scaled-up to produce the quantities required by consumers. Weighing ingredients in much larger quantities requires industrial balances.
For more information on balances suitable for large-scale formulation, please see:
This application guide describes how recipe formulation can be accurately and efficiently undertaken using a simple combination of a handheld barcode reader, a METTLER TOLEDO P-52 printer, and a METTLER TOLEDO MR precision balance.
Read how you can solve typical formulation challenges and follow the step-by-step screenshots to see how easy formulation can be.
METTLER TOLEDO Excellence Level balances enable you to save the formulation method, with ingredient amounts and its individual tolerances, on the balance. The built-in weighing guide helps you to dose to target and will provide a warning if you exceed the predefined limits. If you combine your Excellence Level balance with the LabX laboratory software, LabX can automatically adjust the ingredient quantities in the event that you exceed the tolerance of an ingredient.
With Excellence Level balances you can save a formulation method on the balance which can be run again at any time.
On our balances you can see at any time how many ingredients you have added. The interim results can be viewed at any time directly on the balance display so you can confirm where you are in the formulation process.
On our Excellence Level balances, the formulation method is saved on the balance and will prompt you for the next ingredient by name, providing you with a simpler and more secure formulation process.
On both our Excellence Level and Advanced Level balances, the weight values of the individual formulation ingredients are saved automatically on the balance. The interim results can be viewed at any time. The final results can be printed out or transferred to a PC. Manual transcription of your formulation results is no longer necessary so transcription errors are eliminated, and you have more time to create new formulations.
A good idea is to include barcode labels on your ingredients to uniquely identify each sample. Excellence Level and Advanced Level balances support barcode readers; the ingredient barcode is scanned prior to adding it to the formulation so it's easy to check that you have the right ingredient. By connecting your Excellence Level balance to LabX, a warning will be given if you scan the same barcode again so it's not possible to add the same ingredient twice.
An Excellence Level balance, LabX, a barcode reader and a printer can support you to meet your security and traceability requirements. Using barcodes eliminates the risk of transcription error. On scanning a barcode, LabX will provide prevents from discrepancies from the formulation. LabX can print a detailed, barcoded label for the finished formulation. All the information is stored securely in a centralized database so traceability is assured.
When a balance fails to settle, there is a high chance that the weighing cell is being influenced by electrostatic charges. Electrostatic charges can build up on containers and samples through normal handling so you aren’t doing anything wrong. Sometimes the balance is able to settle but the weight value displayed on the balance may not be the true amount of the substance added, which could explain why reproducibility is poor. Electrostatic charging is one of the biggest hidden sources of weighing error so it's important to take steps to remove electrostatic charges from your containers and samples. Free-standing ionizers can be placed next to your analytical or precision balance; simply pass containers and samples through the ionizer before placing them on the balance. For a comprehensive static detection and elimination solution, Excellence Level analytical balances feature the innovative StaticDetect™ technology. StaticDetect measures the weighing error due to electrostatic charging and provides a warning if user-defined tolerances are exceeded. The Excellence Level optional ionizing module can be set to work automatically when the draft shield doors are closed, eliminating electrostatic charges inside the weighing chamber in just a few seconds.
LabX laboratory software is easily integrated with your LIMS to facilitate the transfer the information related to your formulation components to the formulation method run on the balance.
