無(wú)菌灌裝車間的要求

1、；無(wú)菌灌裝車間的要求Exhibit IV: Aseptic Filling Room Requirements介紹-無(wú)菌包裝 INTRODUCTION - ASEPTIC PACKAGING無(wú)菌灌裝機(jī)（Tetra Brik Aseptic、Tetra Classic Aseptic、Tetra Fino Aseptic、Tetra Wedge Aseptic 等)用于在無(wú)菌狀態(tài)下進(jìn)行商業(yè)消毒產(chǎn)品的灌裝，應(yīng)被放置在與其無(wú)菌設(shè)計(jì)和功能相協(xié)調(diào)的工作環(huán)境中。The aseptic filling machines (Tetra Brik Aseptic, Tetra Classic Aseptic,

2、Tetra Fino Aseptic, Tetra Wedge Aseptic etc.) are utilized for filling of commercially sterile products in aseptic conditions and should be placed in a working environment compatible with its aseptic design and function.無(wú)菌包裝在食品企業(yè)領(lǐng)域內(nèi)有具體尺寸，并且必須根據(jù)下列要求處理。Aseptic packaging has a specific dimension in the

3、 sphere of food industry and must be treated according to the following requirements.無(wú)菌安裝車間的要求ASEPTIC INSTALLATION ROOM REQUIREMENTS無(wú)菌灌裝機(jī)應(yīng)安裝在單獨(dú)的灌裝車間內(nèi)。The aseptic filling machines should be installed in a separate filling room. 只有遵守該條件，空氣傳播的細(xì)菌數(shù)量才會(huì)下降。增加包裝產(chǎn)品帶菌可能性的因素應(yīng)予以避免。如果發(fā)生下列情況，車間中的帶菌可能性將會(huì)增加：Upon com

4、plying with this condition the quantity of airborne bacteria decreases. The factors, which increase the possibility of non-sterility of the packed product, shall be avoided. The possibility of non-sterility increases in the room:- 安裝有酸奶產(chǎn)品或奶粉工廠等的加工機(jī)。- where processing machines for sour milk products

5、or milk powder plants are installed etc. - 安裝有洗瓶機(jī)和洗箱機(jī)。- where washing machines for bottles or crates are installed. - 有強(qiáng)氣流- with strong air-currents. - 有同其他廠區(qū)的往來(lái)交通- with traffic to and from other plant areas. - 有高濕度，如，裝有殺菌器的車間以及在預(yù)殺菌和/或生產(chǎn)期間有蒸汽或熱水排出的車間。- with high humidity, such as the room where the

6、sterilizer is installed and where you have discharges of steam or hot water during pre-sterilization and/or production periods. - 正在進(jìn)行建筑或維修工作，導(dǎo)致?lián)P塵和揚(yáng)土。- Where construction or repair works are being carried out, what causes dust and dirt to appear.灌裝車間的要求FILLING ROOM REQUIREMENTS過(guò)壓Overpressure:整個(gè)灌裝車間應(yīng)

7、借助過(guò)濾的進(jìn)氣口保持“過(guò)壓狀態(tài)”。The filling room, as a whole, should be maintained in an “overpressure condition” by means of filtered air intake. 地板Floors:地板應(yīng)鋪設(shè)防滑、抗酸堿的瓷磚。所有地板/墻角應(yīng)為圓形，以便清潔。排水溝也應(yīng)有到出口的斜坡。Floors should be made of non-slip and acid/alkali resistant tiles. All floor/wall corners should be rounded for ea

8、sy cleaning. The drain gully should also have a fall to outlet.地板從包裝機(jī)的后方到前方應(yīng)有一個(gè)1.5% (1:75)的自然的“斜坡”（廢水聚集在包裝機(jī)的前面）。Floors should have a natural “fall” of 1.5% (1:75) preferably from the back to the front of the packaging machine (waste water exits are located towards the front of the packaging machine)

9、.地板的排水應(yīng)借助溝槽排入一個(gè)有蓋子的“衛(wèi)生排水溝”中。Floor drainage is served by a gully into a covered “hygienic drain”. 墻壁Walls:貼上一米高的瓷磚；瓷磚必須抗酸堿。Tile to a height of minimum 1 m; the tiles must be acid/alkali resistant.上述瓷磚應(yīng)是打磨過(guò)的，以便清潔。Above the tile-line obtain such a finish that can be easily cleaned. 所有窗臺(tái)均應(yīng)是傾斜的，以便清潔并防止其成

10、為儲(chǔ)藏架。All window-sills should be sloped for easy cleaning and preventing their use as storage shelves.門口Doorways：包括包裝機(jī)進(jìn)氣通道在內(nèi)的門口通常應(yīng)關(guān)閉。Doorways including packaging material intake passages are to be normally closed.天花板Ceiling：天花板和天花板的結(jié)構(gòu)必須防水，并易于進(jìn)行干濕清潔。Ceilings and ceiling constructions have to be waterp

11、roofed and easily accessible for the wet and dry cleaning, 通風(fēng) Ventilation：進(jìn)風(fēng)口 Air Intake在灌裝機(jī)的后部有過(guò)濾氣體沿墻壁分布。進(jìn)口高度在0.3米和0.5米之間。At the rear of the filling machine with the filtered air distributed along the walls. Intake height between 0.3 and 0.5 meters.排氣裝置Exhaust：在灌裝機(jī)的前面，進(jìn)風(fēng)口對(duì)面墻的上面。High up on opposite

12、wall to the intake, in front of the filling machines.注Note：由于雙氧水殺菌系統(tǒng)過(guò)多敞露在灌裝車間的空氣中，無(wú)菌灌裝機(jī)需要在上部建筑上有計(jì)算容量為400立方米/小時(shí)的額外的排氣設(shè)施。該排氣量應(yīng)包含在灌裝車間的總體計(jì)算中。Aseptic filling machines need an extra exhaust facility above the superstructure with a calculated capacity of 400 m3/hour as the H2O2 sterilization system is mor

13、e open to the filling rooms atmosphere. This exhaust volume should be included in the overall filling room calculation.特別注意事項(xiàng)Special notes：包裝車間的溫度應(yīng)穩(wěn)定在當(dāng)?shù)剡m合的水平上。該舒適的工作溫度會(huì)隨著地點(diǎn)的不同而有很大不同。通常該溫度為18-300 C。Packaging room temperature should be stable at the local compatible level. Such a comfortable working t

14、emperature varies considerably from place to place. Normally this compatible temperature is 18-300 C.濕度也是一個(gè)兼容性問(wèn)題；低于30%的RH為異常，高達(dá)70%時(shí)可視為舒適Humidity is also a matter of compatibility; an RH of less than 30% is unusual and up to 70% can be considered comfortable.TBA/19和TBA/21包裝機(jī)散發(fā)的過(guò)氧化氫水氣通常由綜合排氣系統(tǒng)連同包裝機(jī)的廢水

15、一同處理。TBA/8機(jī)器為無(wú)菌室配有過(guò)壓排氣裝置，應(yīng)納入車間的通風(fēng)排氣系統(tǒng)。Hydrogen peroxide vapor emitted by the TBA/19 and TBA/21 packaging machines are normally handled by an integrated exhaust system with the packaging machines waste water. The TBA/8 machine is equipped with an overpressure exhaust for the aseptic chamber, which sh

16、ould be incorporated into the rooms ventilation exhaust system.在TFA/3 和TBA/3上方，建議放置過(guò)氧化氫水氣的排放裝置和熱負(fù)荷調(diào)節(jié)器。Above the TFA/3 and TBA/3 it is recommended to place an exhaust for hydrogen peroxide vapor and regulation of thermal load.物理指標(biāo)Physical parameters空氣流速flow rate0.2-0.3 m/s正壓值over pressure2-4 mm H2O溫度

17、 temperature 15-30 °C濕度 humidity30-70 %換氣頻率air change frequency10-15 次/小時(shí)10-15times/hour注意:灌裝間應(yīng)保持溫濕度恒定。Remark: Pls. keep temperature and humidity of filling room stable.衛(wèi)生條件Hygienic requirement一般用空氣降落試驗(yàn)檢查灌裝車間衛(wèi)生狀況，菌落計(jì)數(shù)不超過(guò)30個(gè)。 Have falling out test to check the hygiene condition of filling room a

18、nd total plate count should be no more than 30 cfu per 9 cm plate.空氣降落試驗(yàn)方法:將滅菌營(yíng)養(yǎng)瓊脂倒入直徑9cm并經(jīng)過(guò)滅菌處理的培養(yǎng)皿中,放入灌裝間,打開培養(yǎng)皿暴露15分鐘；而后,放入35±2°C恒溫箱內(nèi)保溫兩天,取出計(jì)數(shù)。The method of falling out test is below, Pls. pour sterilized plate count agar into 9 cm sterilized plate and exposure it in filling room with 15 minutes. After that place the plate into incubator for 48hours under 35±2°C and count it.如果菌落數(shù)大于30個(gè),應(yīng)該對(duì)灌裝間作徹底清洗,并進(jìn)行