The Importance of Batch Control in Manufacturing LIMS

In batch manufacturing products move through the production process in discrete steps. Quality control checks may occur at each stage before the product is released to market or for further processing. The release of the final product only occurs on successful completion of all the QA checks in the manufacturing process. A good current example of batch control that we hear of every day is the release of Covid-19 vaccine. Raw ingredients, which are tested on receipt to ensure the correct quality, are added to a bioreactor^{1} and the vaccine grown over several days. Once completed this intermediate product is transferred from the bioreactor to an isolated storage vessel. Testing is then performed to ensure potency and purity of the solution. The product is then transferred to a fill and finish plant where it is bottled, labelled, and again held while further samples are taken for testing. If testing confirms the quality of the product the vaccine is released for distribution to vaccine centers and use. The vaccine is held in storage awaiting test results at both intermediate and fill and finish product stages which can take many days, causing an inevitable stock buildup and lag in the system. Whilst quality control testing is usually invisible to the public, in a world which awaits vaccine via 24/7 news updates this time lag becomes highly visible.

Figure 1: The Regulated Manufacturing Workflow - Out-of-box configuration

In a laboratory where discrete samples are presented for test the linkage between various sample types are not required. Contract laboratories where samples are sent for test, water laboratories where water samples are collected from multiple locations, and Covid testing laboratories where individual samples are tested, are typical examples of discrete testing.

In these flows, samples are registered, received, tested, validated, and approved largely individually. Samples may be related and compared by sample type, supplier, batch and so forth but each sample is discrete in a non-batch manufacturing laboratory.

By contrast, in a Manufacturing flow samples from across the entire production line, and of very different types, are related. This relationship must be known by the laboratory for traceability purposes. It is this linkage that defines a Manufacturing LIMS from a simple monitoring LIMS. Autoscribe provides dedicated starter systems for both types of laboratory, ensuring that all the key requirements of a LIMS for those environments are already built into the system. This saves considerable time and cost in deploying the LIMS and going ‘live’ in a laboratory.

Key Elements of a Manufacturing LIMS

In a Manufacturing LIMS, materials and their associated samples are classified as Raw Materials (RM), Intermediate Products (IP), or Final Products (FP). IP and FP types can have a defined recipe which specifies the component materials (which may be IPs as well as RMs) and volumes of each that make up the product. As an example, in the brewing industry, Wort (an IP) is made from the raw ingredients Malted Barley and Water. The amount of each RM to use can be defined as a Recipe within the LIMS. Multiple wort recipes may exist for different types of beer.

The different Raw Material batches used must be recorded in the LIMS for traceability purposes. If a problem is found that can be traced to a specific batch of RM the information associated with the batch record means that it can be tracked to supplier, and action taken as required.

Required tests can be automatically assigned to batches based on the materials to be tested, and product specific specifications applied. These identify any test results that are outside the defined product specifications.

The LIMS holds the information required for testing of specific products, including recipes, within pre-defined Batch Templates. Using these the laboratory can quickly register each new batch that is started. This includes the sample and associated tests required at the different stages on the batch process. On completion of the manufacturing process and associated testing batch approval releases the product for use.

Key parts of a manufacturing LIMS include:

• Material and Supplier Management – specifies RM and its sources
• Recipe Management – defines components of IP & FP
• Specification & Test Group Management – defines required testing and product or material test specifications
• Batch Template Management – Models the manufacturing process and associated information within the LIMS

Figure 2: Maintenance Dashboard of the Regulated Manufacturing Workflow - Key Batch Manufacturing Components