The effervescent tube packaging is mainly used to store effervescent tablets. In order to ensure the hygienic performance (microbial limit) of the packaging, the production environment must meet the requirements of the national GMP standard and be produced in a clean workshop. There are specific requirements for the number of dust particles, the number of planktonic bacteria, the number of sedimentation bacteria, etc. The determination of the clean room is carried out in accordance with JGJ 71-90 "Code for Clean Room Construction and Acceptance".
(1) The number of people in the clean room (area) should be strictly controlled, and the temporary outsiders entering the clean room (area) should be instructed and supervised.
(2) Buffer facilities must be set up between the clean room (area) and the non-clean room (area), and the direction of people and logistics is reasonable.
(3) Floor drains should not be installed in the class 100 clean room (area), operators should not operate with bare hands, and hands should be disinfected in time.
(4) The transmission equipment should not pass through the 10,000-class clean room (area) of highly toxic and live toxic organisms, and between the strong allergenic clean room (area) and the low-level clean room (area). The opening of the transmission equipment should be Ensure that the airflow flows from the relatively positive pressure side to the relatively negative pressure side.
(5) Clean work clothes in the area of 100,000 and above should be washed, dried and arranged in a clean room (area), and sterilized as required if necessary.
(6) The surface of the equipment insulation layer in the clean room (area) should be smooth and clean, and no particulate matter should fall off.
(7) Clean room (area) identification or acceptance testing requires that the number of dust particles with two particle sizes and the number of planktonic bacteria or sedimentation bacteria must meet the specified values under static conditions. In addition, the dynamics should be monitored regularly The clean condition under the conditions.
144mm*29mm eff tab tube supplier
(8) If the purified air in the clean room (area) can be recycled, effective measures should be taken to avoid pollution and cross-contamination.
(9) The noise of the clean room (area) should not be higher than 60 decibels (A), among which the local level 100 room should not be higher than 63 decibels (A), the local level 100 area and the whole room should not be higher than the level 100 room. At 65 decibels (A).
(10) The number of air changes and the cross-sectional wind speed of the work area in the clean room should generally not exceed 130% of the number of air changes and cross-sectional wind speed specified by its class, and should be selected according to the design results under special circumstances.
(11) The air purification system should be cleaned, repaired, maintained and recorded as required.
The above are the requirements of the effervescent tube packaging for the production environment. Only the packaging produced under the requirements of the national standard can meet the requirements for the microbial limit of the packaging to ensure that the drug will not be contaminated by the pharmaceutical packaging.
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