Cleanrooms play an important role in the prevention of contamination during the production of food and food supplements. They are most often built around food packaging processes, where there is a high potential for exposure of the finished food product to the atmosphere or people. Ensuring that the environment within the room remains uncontaminated requires continuous monitoring of several variables including air filter condition, product throughput, staff presence, air pressure, and air purity. This multi-variable monitoring creates significant amounts of data, and managing it well is central to maximizing the effectiveness of the entire system.
The importance of data management
The quality of the output of a food production cleanroom hinges on quality of the data generated. If the data collected during the process are inaccurate or poorly managed, it becomes difficult to spot problems quickly and reliably. This limits the value of the entire monitoring process and risks the production of inferior or contaminated products. Ensuring that the products of a food production cleanroom are safe requires quality process monitoring equipment as well as great data management.
The most common and relied upon tool for ensuring effective data management in a food production cleanroom is a laboratory information management system (LIMS). A LIMS manages highly complex and integrated laboratory operations (such as SOPs, methods, and workflow) as well as integration of all instruments for sample management, data collection, reporting, and archiving. The LIMS also connects the laboratory to other enterprise systems, giving management real-time information about the health of the lab and giving the organization the flexibility to demonstrate compliance with any regulatory requirements as needed.
Cost-effective compliance with common standards, such as Hazard Analysis and Critical Control Points (HACCP), is critical to food industry producers. While HACCP has been around for decades, the Food Safety Modernization Act (FSMA), which became law in 2011, made adopting this more rigorous methodology mandatory for a much broader group of food production facilities. Specifically, FSMA section 103, entitled “Hazard Analysis and Risk-Based Preventive Controls,” requires that all affected food producers establish HACCP-based written Preventive Controls Plans. Adherence to these HACCP requirements can be extraordinarily labor-intensive without a highly integrated, paperless system to manage data.
Because HACCP addresses the analysis and control of biological, chemical, and physical hazards from raw material production, procurement, and handling to manufacturing, distribution, and consumption of the finished product, implementing a preventative control plan is onerous. It requires discipline and strict adherence to policies and procedures.
HACCP is based on seven principles that outline a risk mitigation and hazard prevention process. A LIMS is critical to the success all of these efforts.
1. Conducting a hazard analysis
The identification of potential hazards should begin before raw materials even enter the facility. Food producers should create a database of all materials suppliers within the LIMS, so that all materials that pass through the facility can be traced from their point of entry. Next, the manufacturer must identify hazards, which are often found where materials are added, product is extracted, vessels are opened, or final products are packaged.
These locations can all be mapped in the LIMS. Together with supplier data, this digital process map allows cleanroom professionals to identify and track all materials coming through the process from entry to exit. Sample data can be grouped and reviewed by batch, supplier, date, or other categories to identify trends in the cleanroom’s throughput.
2. Identifying critical control points
The next step is to identify the process critical control points (CCPs). In general, a CCP is any part of a food production process where checking the quality of a material can prevent a food safety hazard in the end product.
By storing all CCPs within the LIMS, cleanroom professionals ensure that all food safety data is managed effectively and is easily accessible. Storing control points in the LIMS also greatly increases a cleanroom’s flexibility and scalability; adding a new point or modifying an old one is simple when the facility’s data management system is fully digital.
3. Establishing critical limits
Every control point in the process should also have a clearly defined critical limit—a point, level, or condition that, when not met, can do serious damage the end product. These typically take the form of numeric limits, such as an acceptable parts-per-million or temperature range, but they can also be Boolean conditions for pass/fail limits.
Quickly and accurately identifying products that fall outside a critical limit—preferably before they reach the market—is essential. By collecting critical limit data on all products passing through the cleanroom, a LIMS enables food producers to pinpoint all samples that fall outside the acceptable range and ensure that they are removed from any outgoing shipments.
4. Establishing monitoring procedures
After identifying critical limits at each point in the system, a food production cleanroom must establish monitoring processes for each CCP. A LIMS makes these monitoring procedures much more efficient by fully automating data collection and transmission throughout the organization.
The LIMS not only enables manufacturers to see historical data and generate reports for compliance; it is also used to proactively alert staff when critical limits are exceeded. Because a LIMS is a paperless system, it can support an automated monitoring and response capability that is especially important for cleanrooms that are part of a continuous processing workflow.
5. Establishing corrective actions
When a critical limit is exceeded within a cleanroom, staff must follow a clearly defined process for correcting the issue. A LIMS can help ensure that corrective actions are properly carried out by providing standard operating procedures (SOPs) that walk staff members through the appropriate response to each error.
Assume, for example, that a piece of monitoring equipment connected to the LIMS detected that the condition of a cleanroom air filter had deteriorated to an unacceptable level. The LIMS could then alert the cleanroom staff and provide them with an automated SOP for replacing or cleaning the filter, saving time and ensuring that the job is done correctly. Additionally, the LIMS makes audits by senior staff and regulators easier by recording which staff member performed the corrective action.
6. Defining verification procedures
Out-of-calibration cleanroom monitoring instruments deliver diminished performance that can make accurately determining product quality impossible. To prevent this, HACCP methodology mandates that instrument performance be regularly verified. Just as a LIMS can ensure that corrective actions performed by the staff are done properly, it can also verify that cleanroom instruments are regularly maintained and calibrated. The LIMS can be used to store instrument maintenance schedules and can alert cleanroom managers of the need for maintenance, reducing interruption due to unplanned instrument downtime or malfunction.
7. Establishing recordkeeping procedures
Because a LIMS is entirely paperless, recordkeeping procedures are much more efficient. All data going in and out of the LIMS are automatically recorded digitally, making both internal and external audits for FSMA requirements related to HACCP or other regulatory reviews accurate and reliable. Transitioning from a manual, paper-based system to one that automates nearly all data collection from the cleanroom enables food producers to easily ensure consistent quality, product safety, and industry compliance.
Accurate digital recordkeeping also makes tracing the origin of an error much easier. Determining the source of contamination—whether caused by an out-of-specification process or a questionable raw material—is critical to helping producers mitigate impact during an incident and ensure that it’s not a systemic issue. Once the error is isolated, batches produced between the negative event and the latest acceptable results from the monitoring program can be quickly isolated, limiting the extent of damage and reducing product loss to only the batches that have actually been compromised. The LIMS also generates incident reports for all product quality issues, which can be provided to management or regulatory bodies upon request.
Traceability outside the cleanroom
In an ideal world all food safety issues would be detected before any products left the cleanroom. Unfortunately, experience has proven that this is unlikely to ever be the case. In the event that a contaminated food product does leave the production facility, a LIMS provides critical traceability that can help reduce the potential harm and financial impacts caused by the error.
By systematically monitoring batches of raw materials, processed materials, and packaged goods as they pass through the cleanroom, a LIMS provides manufacturers with the data they need to rapidly identify contaminated batches. This allows them to see exactly where contamination occurred, automatically suspend release of a product during investigation, and identify shipped products that may need to be recalled. While no manufacturer wants to have to recall products, the ability to parse data stored by the LIMS and accurately identify contaminated shipments can drastically reduce the scope and cost of a recall operation.
A LIMS also adds security to the process, logging important data such as location, operator, and manifests so that the entire journey of a batch—and its viability the entire time—is a matter of record. Information ranges from safety test results, including foreign body, pesticide, and microbiological analysis, to raw ingredient identification analysis. Information on hazards or substandard processing, such as poor storage somewhere in the supply chain, exists within the LIMS for reference when and how it’s needed.
Colin Thurston is a Project Director with Thermo Fisher Scientific of Waltham, Mass. www.thermofisher.com
This article appeared in the September 2014 issue of Controlled Environments.