In batch manufacturing, products progress through the production process in a series of controlled, discrete stages. Quality control (QC) checks are typically performed at each step to verify that the product meets defined specifications before it can proceed to the next stage or be released to the market. Final product release occurs only after all quality assurance (QA) tests throughout the manufacturing process have been successfully completed.
A well-known recent example of batch control is the production and release of COVID-19 vaccines1. Upon arrival, raw ingredients are tested to confirm their quality and suitability for use. These materials are then combined within a bioreactor, where the vaccine is cultivated over several days. Once the growth phase is complete, the intermediate product is transferred to an isolated storage vessel for further testing to confirm potency and purity.
After passing these checks, the vaccine moves to a fill-and-finish facility, where it is bottled, labeled, and held once more for additional sampling and testing. Only when all test results confirm that the product meets strict quality and safety standards is the vaccine released for distribution to healthcare providers and vaccination centers.
Throughout this process, vaccines are held in storage during both the intermediate and fill-and-finish stages while test results are pending, a delay that can extend over several days. This necessary waiting period inevitably leads to stock buildup and short-term bottlenecks within the supply chain. While these quality control steps are typically invisible to the public, the urgency of global vaccine distribution—and constant 24/7 media coverage- made this behind-the-scenes time lag highly visible during the pandemic.
Figure 1: The Regulated Manufacturing Workflow – Out-of-box configuration
The manufacturing process is closely monitored throughout. Traceability is key and it must be possible to link batches of materials used to the testing carried out during the process. Should any issues be found, the source can be identified and if the problem lies in a raw material or intermediate material batch the concept of traceability means any other products those batches have been used in can be identified.
In a laboratory where discrete samples are presented for testing, linkage between various sample types is not required. Contract laboratories where samples are sent for testing, water laboratories where water samples are collected from multiple locations, and COVID-19 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 distinguishes a Manufacturing LIMS from a simple monitoring LIMS. Instem provides dedicated starter systems for both types of laboratories, ensuring that all the key requirements of a LIMS for those environments are already built into the system. This saves considerable time and money by 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 that 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 the 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.
LIMS holds the information required for testing 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 different stages of the batch process. On completion of the manufacturing process and associated testing, batch approval releases the product for use.
Key parts of 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
Why is this different from Non-Batch Manufacturing Laboratories?
Products are typically manufactured to a set of defined manufacturing specifications. However, other product specifications may exist for specific customers or markets. It can therefore be important to check what other specifications a product meets. Batch Grading functionality allows the product to be assessed against multiple specifications. In this way, a batch of products can be matched to the most suitable market or customer, maximizing its value.
A LIMS, however, is not just limited to managing product testing. An integrated LIMS solution should have other modules that assist in the running and management of the laboratory; these include User Competency, Instrument Calibration & Maintenance, CAPA, and Laboratory (Chemicals) Inventory Management.
Flexibility Remains Key
Despite many similarities, no two manufacturing laboratories are ever identical in the way they work or the data they must capture. Matrix Gemini LIMS is built around a genuinely configurable approach. Using graphical configuration tools, screens, and workflows, and the functionality behind them can be modified to meet specific needs. This is done without software coding and is isolated from the underlying Matrix Gemini LIMS product software.
This has a huge impact on the flexibility of the system, making it easy and cost-effective to define specific workflows for users or types of users. These can be as simple or as complex as required, and once they have been implemented, this configured functionality is not impacted by future developments of the underlying software that Instem releases. So confident are we of this that not only do we undertake to support any configuration work that we may do for our customers, but we also support configuration work they may choose to do themselves.
Ensure full traceability, streamline quality control, and optimize every stage of your manufacturing process. Discover how Matrix Gemini LIMS can enhance batch management and future-proof your laboratory—contact us today to get started.
References:
1: Covid-19 vaccine production processes vary. References to two examples of vaccine production processes are described here:
