The most popular HACCP system and aseptic packagin

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HACCP system and aseptic packaging technology (therefore in)

when starting the risk factor analysis, first of all, it is necessary to identify the characteristics of relevant products and their equipment, and investigate the possible harm and adverse effect on users or consumers under what state. The manifestation of risk factors is often the failure or error of product performance, causing users or consumers to have direct and potential harmful consequences in physiology and psychology. The risk factors are embodied in organisms, which will include biocompatibility risks, bacterial contamination and microbial contamination, pathogenic bacteria, biological deposition, in order to meet the personalized needs of consumers for the appearance of parts and body tissue compatibility. These biological risk factors may cause tissue infection and human disease. In injectable medical devices, any microbial tissue has the potential risk of causing disease, and may cause damage to human immunity to a certain extent. Therefore, when analyzing risk factors, we must pay full attention to them and include them in the analysis items

III. characteristic indicators of sterile packaging

all processed food, drugs and medical products must rely on disinfection means to remove all kinds of microorganisms and bacteria that may be produced due to the processing process and its environmental conditions. After completing the disinfection procedure, packaging is the only protective barrier to prevent microorganisms from entering or contacting the packaged products. The establishment and maintenance of this barrier is one of the most important functions of aseptic packaging technology. To evaluate the effectiveness and functionality of aseptic packaging, the two most commonly used characteristic indicators are the sealing integrity and, especially, the sealing strength of the nozzle and the heating part close to the nozzle

sealing integrity refers to the structural integrity of sterile packages, which can be evaluated by any physical or visual effective test method. This test result can indicate whether there is structural continuity or permeability in the sealed part of the package. This test, together with the microbial barrier test of packaging materials, can evaluate whether the packaging structure has qualified structural integrity on the whole

sealing strength refers to the strength condition of the sealing part of the package under the action of external force, which is a characteristic index completely different from the above structural integrity. Sealing strength and sealing integrity are incompatible and independent, which indicates that the allowable sealing strength does not necessarily ensure the allowable sealing structural integrity, and vice versa. In view of this situation, the comprehensive evaluation of the two characteristic parameters of seal strength and seal integrity requires different test methods and inspection regulations

since the normal sealing process operation of packages always uses processing equipment with good performance, and this equipment is usually operated and inspected by personnel with qualification certificates, once the structural integrity of sealed packages is damaged or invalid suddenly, it will have significant effects and repercussions on users or consumers (including human bodies), This serious problem with the integrity of the sealing structure may be close to the "maximum allowable value of the danger limit." Such analysis results, in particular, can promote the medical and pharmaceutical manufacturing industry and food processing industry and other departments to fully recognize the seriousness of this dangerous event and establish effective and reasonable supervision and control procedures

IV. establishment of control points

1. Determination 1 Pull off experiment main control point

critical control point (CCP) refers to the special points in the process of program control flow in HACCP system. Through these points, control and monitoring means can effectively prevent, eliminate or reduce hazardous factors at the specified allowable level. Critical control point is the essential main performance parameter in these positions, so it is also called primary control point (ECP), or master control point. This is usually the last step in the system control flow. It may be impossible to completely eliminate or avoid all risk factors, but in this control and monitoring process, minimizing the degree of risk under certain risk factors is a reasonable goal of the HACCP system

in the sealing operation using sterile packaging technology, there are no special or subsequent steps to help control the sealing process. Although the sealing strength can be improved through reasonable selection of packaging materials, effective sealing processing and control of important process parameters, the sealing process can be comprehensively monitored only through strict testing procedures at the sealing place. Before the package is used, the sealed part that can maintain the sterile state of the product in the general processing process is generally defined as the main control point. (to be continued)

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