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