It is vital to possess a tight formulations control process in any laboratory environment. A robust formulations management plan can help to meet specifications, ensure product quality, and decrease manufacturing costs to ensure profitability.
The more regulated the industry segment is, the more stringent the formulation requirement becomes. In order to ensure product quality, effectiveness, and safety, strict guidelines are put in place.
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The challenges associated with product formulation processes will be addressed and how a Laboratory Information Management System (LIMS) can combat those challenges will be discussed in this white paper.
Product formulation challenges
Homemade formulations which do not have adequate controls, checks and balances, do not enable consistency across batches. If you were preparing a simple formulation for a smoothie using sweetening agents, fruits, yogurt and ice, you could have a good idea about the amounts required to create the smoothie.
Products which are produced on different days of the week may have some differences but may still taste very similar. The difference in quality and consistency between homemade batches is because of the inability to utilize highly accurate measuring instruments, specific production conditions (temperature, time etc.), clearly documented processing steps, and quality checks.
For the majority of the formulations used in the industry for production, this is not the case. Here, the degree of control utilized in formulations for product manufacturing is of huge importance and impacts product consistency, reliability, quality, and safety directly.
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Generally, formulations do not involve chemical reactions or synthesis; they are performed by measuring solids by weight and liquids by volume. Although there are no chemical reactions involved, there are multiple aspects of chemistry present in a formulation, i.e. the thermodynamics of mixing, surface chemistry, colloids, solutions, phase equilibria, emulsions and suspensions.
More crucial is how these principles are connected to biodegradability, weather resistance, adhesion, texture, shelf life, allergenic response and numerous other properties.
A lot of the time, formulations development is performed by fairly rudimentary trial and error techniques. That can work for one-off formulation development, a robust system must be in place for routine large-scale development operations.
Critical in regulated industries
In heavily regulated industries like Biopharmaceutical, it is vital to possess good control of the formulation process. It is important to document the development, testing, approval and lifecycle management of formulations properly. Only those products with formulations which meet regulatory approvals may be distributed.
Then, routine commercial product manufacturing is based on this specific proportion of ingredients, conditions, processing steps, controls and quality specifications. For instance, the bioavailability and rate of dissolution of a solid dosage drug product can vary widely based on its processing parameters and formulation considerations.
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Imagine a platform where comparing slight differences within numerous formulations will enable a scientist to compare the results side-by-side and establish the next steps. It is crucial that a finished product will lack variance between batches and have a high degree of uniformity, which increases the overall quality.
That is only viable with the considerable effort and expertise of a formulating scientist, and meticulous documentation of formulations development and testing may be needed.
For appropriate manufacturing based on well-defined processes it is also critical to consider the many variables that can affect composition, physicochemical properties, stability and utility of the products. Plus, it is important to think about the cost component so that it is marketable against the competition.
Records retention is crucial
Keeping detailed documentation on development research and the ability to search through historical records is vital to the formulations process. Mining and reuse of legacy information is important for the process of knowledge management and can save huge amounts of time and money.
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It is indispensable to have a robust documentation and information management platform for the formulation of a new product. Proper documentation and the ability to produce intelligence from them will avoid wasting time and resources when lab scale experiments are carried out.
For low margin industry/products, it makes most sense to consider the ingredient and processing costs carefully, from the beginning. This can stop any mistakes by having a choice to check historical records of trial formulations, their output, product results and costing.
Without a universal technique for documentation, storage and retrieval, collating and searching for any helpful information becomes extremely challenging. Information may be stored on shared hard drives or individual computers.
In the worst instance, the information may not be found. Only a robust electronic system, which provides complete historical search capabilities based on user-defined parameters, can really benefit an organization.
This type of formulations management platform will stop the requirement for scientists to document anything outside of the system and provide a comprehensive set of capabilities for developing and managing formulations.
LIMS to the rescue
Implementing a LIMS solution with robust formulations management capabilities can combat a lot of the challenges in managing the formations process. It will make life easier for scientists and managers in properly managing all product formulation requirements from early initiation through to the end of a formulation.
Possessing the right tools makes a massive difference in your product quality, and ultimately, your profitability. Some of the main formulation capabilities to look for in a LIMS system include:
- User friendly interface that enables a change of ingredient quantities within a formulation and the ability to see the effect of those changes on the cost or physical properties
- Formulation templates which are reusable to save time and effort
- Complete indexing capabilities and historical data search
- Accommodation for varying sample calculation requirements
- The ability to move formulations from one stage to the next with clear management approval
- Robust capabilities for sample and specifications management, and product testing/analysis during different stages of formulation
Summary
Getting your formulations process right means enhanced time to market, better product quality, and lower cost, providing you with a competitive advantage. Sadly, when deciding upon a formulations strategy, the idea to purchase a LIMS solution with robust formulations management capabilities is frequently overlooked.
LIMS is often thought of as a complex “Information Technology” solution, used by scientists for product testing and sample management. Contrary to that misconception, a LIMS solution is crucial for any type of laboratory environment which needs management and documentation of complex scientific information for product development and sample testing.
A modern, robust, highly configurable LIMS solution with integrated formulations management capability will play a key role in managing the process for establishing the right formulation.
About LabVantage Solutions
LabVantage Solutions, Inc. is the leading global laboratory informatics provider. Our industry-leading LIMS and ELN solution and world-class services are the result of 35+ years of experience in laboratory informatics. LabVantage offers a comprehensive portfolio of products and services that enable companies to innovate faster in the R&D cycle, improve manufactured product quality, achieve accurate recordkeeping and comply with regulatory requirements.
LabVantage is a highly configurable, web-based LIMS/ELN that powers hundreds of laboratories globally, large and small. Built on a platform that is widely recognized as the best in the industry, LabVantage can support hundreds of concurrent users as well as interface with instruments and other enterprise systems. It is the best choice for industries ranging from pharmaceuticals and consumer goods to molecular diagnostics and bio banking. LabVantage domain experts advise customers on best practices and maximize their ROIs by optimizing LIMS implementation with a rapid and successful deployment.
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