根據(jù)2013年實施的《潔凈廠房設(shè)計規(guī)范》，其明確指出潔凈廠房要“工藝平面布置應(yīng)合理、緊湊。潔凈室或潔凈區(qū)內(nèi)只布置必要的工藝設(shè)備以及有空氣凈化度要求的工序和工作室”。對于藥廠而言，gmp標(biāo)準(zhǔn)是十分重要的，防止?jié)崈羰医徊嫖廴臼莋mp的重點之一。交叉污染就是指人員往返、物料運輸、工具運輸、空氣流動、設(shè)備清洗與消毒、崗位清場等活動將不同成分混合而導(dǎo)致污染;或者是壓差廢、等導(dǎo)致潔凈度低區(qū)域的空氣流入的潔凈度高的區(qū)域，這對于潔凈室而言都是致命的，在潔凈室的運行過程中一定要避免交叉污染，以免造成巨大的損失。
According to the "Cleansing Workshop Design Code" implemented in 2013, it
is clearly pointed out that "the layout of the process plan should be reasonable
and compact." The cleanroom or clean area shall be furnished only with the
necessary process equipment, as well as processes and workshops with air
cleanliness requirements. " Gmp standard is very important for pharmaceutical
factory, and preventing clean room cross-contamination is one of the key points
of gmp. Cross contamination refers to the movement of personnel, material
transportation, means transportation, air flow, equipment cleaning and
disinfecting, and other activities, such as mixing different components to cause
pollution; Or pressure drop waste, etc., causing air to flow into low
cleanliness areasHigh degree area, this is fatal to clean room, must avoid cross
pollution during operation of clean room, lest cause huge loss.
你知道如何防止潔凈室交叉污染嗎?
Do you know how to prevent cross-contamination of clean rooms?
第一步、合理布局
對于室內(nèi)的布局，要根據(jù)合理的工藝流程來進行布局，避免來回往返。合理布局既有利于工藝操作，也有利于空間的整合。潔凈室并不是越大越好的，送風(fēng)量是根據(jù)面積和空間大小來決定的，也決定了能耗。潔凈室的面積不能過大或者過小，不要有預(yù)留閑置的面積和空間，也不能太小影響操作、維修。
合理的布局是通過考慮設(shè)備大小、工藝操作的需求，生產(chǎn)區(qū)和儲存區(qū)應(yīng)有與生產(chǎn)規(guī)模相適應(yīng)的空間面積，用以安置設(shè)備、物料，便于操作和維修。一般潔凈室高度控制在2.60米，對個別較高的設(shè)備可在局部加高，而不宜全面提高潔凈區(qū)的高度。車間內(nèi)部應(yīng)設(shè)有物料的中間站，其面積足以存放物料、中間產(chǎn)品、待驗品和成品，且便于明確分區(qū)，以最大限度地減少差錯和交叉污染。
Step one, reasonable layout
For indoor layout, according to the reasonable process to layout, avoid
round trip. Reasonable layout is not only conducive to the operation of the
process, but also conducive to the integration of space. Clean room is not the
bigger the better, the air supply is determined by the size of the area and
space, but also determine the energy consumption. Clean room area must not be
too large or too small, do not have reserved space and spare space, nor too
small impact on operation, maintenance.
The reasonable layout is to take into account the size of the equipment,
the requirement of the process operation, the space area of the production area
and the storage area, which should be suitable for the production scale, so as
to arrange the equipment and materials, and facilitate the operation and
maintenance. The general cleanroom height is controlled at 2.60 meters, and the
height of the clean area can be raised locally for some higher equipment, but it
is not suitable to increase the height of the clean area in an all-round way.
There should be an intermediate station for materials in the workshop, which is
large enough to store materials, intermediate products, products to be inspected
and finished products, and to facilitate clear zoning in order to minimize
errors and cross-contamination.
第二步、提高設(shè)備水平
設(shè)備的材質(zhì)、加工精度、密閉程度以及管理制度都與交叉污染有關(guān)。所以除了合理布局外，提高設(shè)備的自動化水平和組成聯(lián)動的生產(chǎn)線，以減少操作人員，降低人員的活動頻率，是防止交叉污染的必要措施。
The second step is to raise the level of equipment
Equipment material, processing accuracy, airtight degree and management
system are related to cross-contamination. Therefore, in addition to reasonable
layout, it is necessary to improve the automation level of the equipment and
form a linkage production line in order to reduce the number of operators and
reduce the frequency of activities of the personnel, which is the necessary
measure to prevent cross-contamination.
