For every laboratory environment, it is essential to have a stringent formulations control process. A strong plan for formulations management will assist teams in meeting specifications, ensuring product quality, reducing manufacturing costs, and increasing profitability.
Industries that are heavily regulated typically have more stringent formulation requirements. Ensuring product effectiveness, quality, and safety will require implementing strict guidelines.
Addressing the demands involving product formulation processes and the way a LIMS (Laboratory Information Management System) can help will be summarized below.
Formulations that are made at home without sufficient controls, along with checks and balances, will not result in consistent batches. A preparation of a smoothie with a simple formulation comprised of fruit, yogurt, sweetening agents, and ice in your kitchen would provide the basis of the ingredients and their amounts need to make the smoothie. However, consistency in texture and flavor may be greatly different from preparation to preparation.
In contrast, manufactured batches will have greater quality and consistency because precise measuring instruments, particular conditions, such as temperature and timing, steps clear documentation, and quality checks were implemented. The greater level of control used in the product formulations in manufacturing is quite crucial because it will directly affect product quality, reliability, consistency, and safety.
Typically, formulations will not involve synthesis or chemical reactions. They are usually created by measuring liquids by volume and solids by weight. Even though chemical reactions aren’t involved, a formulation may include several aspects of chemistry, such as colloids, emulsions, phase equilibria, solutions, surface chemistry, suspensions, and thermodynamics of mixing. Even more important is how these aspects are related to adhesion, allergenic response, biodegradability, shelf life, texture, weather resistance, and many other properties.
In many cases, formulation development is carried out through basic trial and error methods. Although this can be sufficient for the development of one-off formulations, a much stronger system must be implemented for standard industrial-scale development operations.
Part 2 will discuss Heavily-Regulated Industries and Importance of Record Retention.
Alpha has been involved with the implementation of over 50 LIMS systems ranging in size from small, “off-the-shelf” software systems to very large, highly customized, multi-functional systems, including STARLIMS, for both governmental agencies and private enterprises. For affordable client-focused network consulting services and solutions, please call Alpha Engineering Associates today at (410) 295-9500.