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Third, the characteristics of aseptic packaging specifications After the completion of the food, medicine and medical products have to rely on disinfection to remove all kinds of microorganisms and bacteria that may be generated due to the processing process and its environmental conditions. After completion of the sterilization process, the packaging is the only protective barrier against the entry of microorganisms or other substances into the packaged product. The establishment and maintenance of this sterile barrier with barrier properties is one of the most important functions of aseptic packaging technology. Assessing the effectiveness and functionality of aseptic packaging, the two most commonly used specifications are seal integrity and seal strength.
Seal integrity refers to the integrity of the aseptic package structure. This property can be determined by any physical or visual test method. This test result can indicate whether the sealed part of the package has a structure. Continuity or permeability. This test, together with the microbial barrier test of the packaging material, can give an overall assessment of whether the package structure has a satisfactory structural integrity.
The seal strength refers to the strength condition of the sealing part of the package under external force, which is a completely different characteristic index from the above structural integrity. Sealing strength and seal integrity are incompatible and independent, which means that acceptable seal strength does not necessarily ensure acceptable seal integrity, and vice versa. In view of this situation, the comprehensive evaluation of two characteristic parameters of seal strength and seal integrity requires different test methods and inspection regulations.
Since the normal sealing process of the package always uses good-quality processing equipment, and such equipment is usually operated and inspected by a person who holds a qualification certificate, once the package structural integrity destruction or failure occurs suddenly, Then, with the significant effect and repercussions on users or consumers (including the human body, etc.), the serious problem of the structural integrity of the seal may be close to the "maximum allowable value of the risk limit." Such analysis results, in particular, can promote medical drugs. The manufacturing and food processing industries and other departments fully recognize the seriousness of such dangerous events and establish effective and reasonable supervision and control procedures.
IV. Establishment of control points 1. Definitions The main control point Critical Control Point (CCP) refers to the special point of the process control flow process in the HACCP system. Through these points, control monitoring means can effectively prevent, eliminate or eliminate Reduce the risk factors. The critical control point is the main performance parameter that is necessary to represent these locations. Therefore, it is also called the major control point (ECP), or the main control point. This is usually the last step in the system control flow. It may not be possible to completely eliminate or avoid all risk factors. However, in the process of controlling and monitoring, under certain risk factors, minimizing the risk is a reasonable goal of the HACCP system.
In sealing operations using aseptic packaging technology, there are no special or subsequent steps that can help control the sealing process. Although the sealing strength can be improved through the proper choice of packaging materials, effective sealing process, and control of important process parameters, the sealing process can only be fully monitored through a rigorous sealing procedure. Before the package is used, the sealed part that can maintain the sterility of the product during the general process is generally defined as the main control point. (To be continued)
HACCP System and Aseptic Packaging Technology (center)
When starting a risk factor analysis, first of all, it is necessary to identify the characteristics of the product and its equipment, and to examine what kind of conditions may cause harm to users or consumers and adverse effects. The form of risk factors is often the failure or error of the product's performance, resulting in direct and potential harm consequences to the user or the consumer, both physically and psychologically. Risk factors are reflected in the biological aspects, including biocompatibility hazards, bacteria and microbial contamination, pathogenic bacteria, organism deposition, and body tissue compatibility issues. These biological risk factors can cause tissue infections and human illness. In injection-type medical devices, any microbial tissue has the potential danger of causing disease, and may cause a certain degree of damage to human immunity. Therefore, when analyzing risk factors, we must pay full attention to and include in the analysis project.