echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Active Ingredient News > Drugs Articles > Medical equipment purification engineering - dust free purification room technical solution

    Medical equipment purification engineering - dust free purification room technical solution

    • Last Update: 2018-06-11
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    Medical device purification engineering - Code for design of sterile clean room engineering: 1 International standard ISO / DIS 14644; 2 Code for design of clean room workshop (GB50073-2001); 3 Code for design of clean room workshop of medical device packaging workshop (gmp-97); 4 Code for quality management of pharmaceutical production (gmp-98); 5 Code for construction and collection of clean room (JGJ 71-90) 6 Code for construction and acceptance of ventilation and air conditioning engineering (GB 50243-2002) 7 American federal standard (fs209e-92), according to the requirements of relevant specifications, requires the construction of clean rooms that meet the relevant standards for sterile medical device production workshops, drug production workshops, medical biology laboratories, operating rooms, etc During the construction or reconstruction of the clean room, the final completion acceptance cannot be relied on to ensure the quality of the clean room The quality of the clean room must be strictly checked from the design and equipment selection stage During the whole process of construction, the main key points must be strictly inspected and supervised, and regular monitoring in actual use can ensure that the clean room can meet the design index and use requirements The following problems should be considered in the construction of medical device purification project: 1 Purification materials required by clean room project of medical device packaging workshop; 2 Comprehensive services such as design, installation, commissioning and maintenance of clean room project of medical device workshop and medical device packaging workshop; 3 Air conditioning purification part of clean room project of medical device packaging workshop Temperature and relative humidity when there is no special regulation for sterile medical devices, the temperature is usually required to be 18-28 C in the regulatory standard, and the humidity is 45% - 65% Generally, the enterprise can control the temperature within the requirements If it can not meet the requirements in the dynamic monitoring, it may be that there are instruments and equipment with large heat production in the room Air volume, air change times and static pressure difference when the volume of the clean room is determined, the air change times are determined by the air supply volume of the room, while the static pressure difference is determined by the difference between the air supply volume, return air volume and exhaust air volume of the room The total supply air volume, fresh air volume, total exhaust air volume and external pressure difference of the system can be realized by adjusting the fan frequency speed or the opening degree of the main valve, and the air volume and pressure of each room can be realized by adjusting the opening degree of the branch pipeline valve In the actual detection process, it is found that when the air supply volume of a clean room with unqualified air change times is adjusted by adjusting the branch air valve, the air supply volume of the rest clean rooms in the same clean area will change, that is, the air distribution of the whole clean area will be disrupted, which makes the problem more complex In addition, it is often encountered that the number of air changes is qualified and the pressure difference is unqualified, which is more common in the second case The main reason is that the air tightness of the enclosure structure is poor and the grid of the return air inlet is not easy to adjust In the dynamic monitoring of clean rooms, the main reasons for the change of the pressure difference between clean rooms are the flow of people, the insufficient fresh air volume and the frequent opening of doors If the static pressure difference between clean rooms and the atmosphere or between clean rooms of different levels is in a critical state, it is likely that the pressure difference can not meet the requirements due to the flow of people and the insufficient supply of fresh air during the dynamic detection If the test conditions of suspended particles, floating bacteria and settling bacteria fail to meet the requirements of specified environmental parameters (temperature and humidity, wind speed, air change times, static pressure difference within the specified range), the test results of key items, suspended particles, floating bacteria or settling bacteria, shall be regarded as invalid As temperature, relative humidity, wind speed, air change times and static pressure difference constitute the microclimate of the clean room, which is an important indicator of whether the clean room is maintained normally or not, the key process key item test can be revised to the key process full performance test Only in this way can the production clean room be monitored comprehensively and systematically In order to ensure the scientificity and accuracy of the performance monitoring data of the clean room, the testing department should test the temperature, relative humidity, air change times, static pressure difference and other preconditions at the same time when testing the suspended particles and microorganisms of key projects The test standards of the clean room design of pharmaceutical clean room and sterile medical equipment in terms of temperature, relative humidity, wind speed, air change times and static pressure difference are all implemented in accordance with the code for design of clean workshop The problems in the design of clean room of pharmaceutical factory also have reference value for sterile medical equipment clean room The reason why the room temperature of the clean room exceeds the design range in summer is that the air supply volume of each clean room, i.e the air change frequency, which was determined at the beginning, only pays attention to meeting the cleanliness index, and ignores the check calculation of the heat balance of each clean room Therefore, in the process of design and operation of the production clean room, it is necessary to modify the parameters of air conditioning and air supply in the clean room in real time to ensure that the temperature of the production clean room is maintained at 18-28 C in each season Temperature and relative humidity mainly affect the production process and bacterial reproduction conditions, and also cause the impact of the comfort of production operators on product quality Air supply volume and air change times the determination of air supply volume in the design stage of medical equipment purification engineering sterile clean room engineering should meet the air change times requirements of the corresponding cleanliness level, and at the same time, the air volume should be further determined through the heat and humidity load check, on this basis, the filter should be selected The treatment air volume of the filter shall be less than or equal to the rated air volume, and the resistance and efficiency of the (sub and super) air filter set in the same clean area shall be close Generally, the air supply volume of the clean room shall be the large value of the following 3 items: the air supply volume to ensure the air cleanliness level; the air supply volume calculated according to the heat and humidity load; and the fresh air volume supplied to the clean room The fresh air volume shall be the large value of the following 2 items: the sum of the fresh air volume required to compensate the indoor exhaust air volume and maintain the indoor positive pressure value; ensure that the fresh air volume supplied to each person in the clean room per hour is not less than 40m3 For a specific clean room project, the air change frequency should be determined according to the actual situation In particular, the cleaning requirements are low, sometimes the number of air changes depends on the indoor heat Generally, a ventilation frequency is calculated according to the dust emission of indoor staff and equipment (or the dust emission of staff multiplied by a factor), whichever is larger Sometimes, for the sake of safety, the ventilation frequency can be calculated by multiplying by a service factor Dust particles, suspended particles and microorganisms mainly affect product quality and cause cross infection 80% - 90% of the dust and bacteria in the clean room come from outdoor air, and 80% - 90% of them come from people in other factors, such as people and enclosure structure It can be seen that in addition to the dust and bacteria brought by the outdoor air, personnel are the main reason for dust particles in the clean room The test data show that the movement range and the speed of walking are different The operation of the cleaning room operator should be gentle and stable, and unnecessary actions should be avoided as much as possible, especially the lower limb movements such as fast walking, so as to reduce the dust production in the clean room Due to different materials and styles, there are great differences in dust production It should be one-piece, dense nylon thick clean clothes, which produce less dust than other kinds of clean clothes The design of clean room adopts epoxy resin self leveling coating on the ground and metal color steel siding, which produces less dust than other building materials Therefore, from two aspects of personnel control and plant design, the number of dust particles in the clean room can be reduced In addition to controlling pollution sources and reducing the amount of pollution to prevent particulate pollution in the clean room, air purification treatment methods such as controlling the pressure in the room can effectively prevent outdoor pollution from invading the room or preventing indoor pollution from escaping out of the room The reasonable air distribution can effectively eliminate the indoor pollution These ways are all related to the air volume (wind speed) or air change times of the purification system Clean room is a complex with requirements for air change times, static pressure difference, temperature, humidity, illumination, etc The design, construction, monitoring and management of the clean room are equally important The clean room construction of sterile medical devices should start from the design, and the clean room monitoring involves the enterprise's own management procedures and personnel operation training Before the clean room is put into operation, comprehensive performance verification shall be carried out, including design before construction, project preparation, monitoring of construction period, static monitoring after completion, dynamic monitoring of actual production process, etc The enterprise should establish a set of scientific and effective clean room management system and procedures, and record and analyze and solve the existing problems in time Code for design of clean workshop of pharmaceutical industry (gb50457-2008) has been issued in November 2008 and implemented from June 1, 2009 This is another national standard following code for design of clean workshop (GB 50073-2001), which will provide guidance for design of clean workshop of pharmaceutical industry With the introduction of operable standards, monitoring the clean room will become an important guarantee of clean production environment The construction of clean room for sterile medical equipment production is developing rapidly, which plays an important role in improving product quality Product quality is not detected but produced by strict process control Environmental control is the key link of production process control It is very important for product quality to do a good job of clean room monitoring At present, the monitoring of clean room in medical equipment manufacturing enterprises is not popular, and the importance of clean room is not well understood How to correctly understand and implement the current standards, how to carry out a more scientific and reasonable evaluation of the clean plant, how to put forward a reasonable test index for the operation and maintenance of the clean plant are the common concerns of the enterprise and the monitoring and supervision personnel Attention to the construction of clean rooms for medical devices: 1 The requirements for site selection should be considered: the natural environment and sanitary conditions around the site are good, at least there is no air or water pollution source, and it should be far away from the main roads, freight yards, etc 2 Environmental requirements of the plant area: the ground and road of the plant area shall be flat and free from dust It is advisable to reduce the exposed area or take measures to control dust through greening Garbage, idle articles, etc shall not be stored in the open air In short, the environment of the plant shall not cause pollution to the production of sterile medical devices 3 The overall layout of the plant area shall be reasonable: it shall not have adverse effects on the production area of sterile medical devices, especially the clean area The layout of clean room (area) requires that the level of cleanliness shall be set according to the guidance for setting the cleanliness level of sterile medical equipment production environment in Appendix B of the specification for production management of sterile medical equipment Clean room (area) design should pay attention to the following aspects: 1 According to the production process layout The process shall be as short as possible to reduce cross and back, and the flow of people and logistics shall be reasonable The personnel purification room (coat room, washroom, clean work clothes room and buffer room), material purification room (unpacking room, buffer room and double-layer transfer window) must be equipped In addition to the use room required by the product process, the cleaning room, laundry room, temporary storage room, tool cleaning room, etc shall also be equipped Each use room is independent of each other The area of the cleaning workshop shall ensure the basic requirements Under the premise of seeking, it is suitable for the production scale 2 According to the level of air cleanliness, it can be written in the direction of people flow, from low to high; the workshop is from inside to outside, from high to low 3 There is no cross pollution in the same clean room (area) or between adjacent clean rooms (areas) 1) the production process and raw materials will not affect the products
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.