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.
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.
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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.
2. Identifying critical control points
The next step is to identify the process critical control points – any part of a food production process where checking the quality of a material can prevent a food safety hazard in the end product.
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.
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.
5. Establishing corrective actions
When a critical limit is exceeded within a cleanroom, staff must follow a clearly defined process for correcting the issue.
6. Defining verification procedures
HACCP methodology mandates that instrument performance be regularly verified.
7. Establishing recordkeeping procedures
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.