Formulation 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:
- Recipe complexity / number of ingredients, variety of recipes
- Ensuring SOPs are followed
- Skill of the scientist
- Documentation and Traceability
- Data management and Data integrity (ALCOA+)