无菌灌装车间的要求

无菌灌装车间的要求

Exhibit IV: Aseptic Filling Room Requirements

介绍-无菌包装INTRODUCTION - ASEPTIC PACKAGING

无菌灌装机（Tetra Brik Aseptic、Tetra Classic Aseptic、Tetra Fino Aseptic、Tetra Wedge Aseptic 等)用于在无菌状态下进行商业消毒产品的灌装，应被放置在与其无菌设计和功能相协调的工作环境中。

The aseptic filling machines (Tetra Brik Aseptic, Tetra Classic Aseptic, 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.

无菌包装在食品企业领域内有具体尺寸，并且必须根据下列要求处理。

Aseptic packaging has a specific dimension in the sphere of food industry and must be treated according to the following requirements.

无菌安装车间的要求ASEPTIC INSTALLATION ROOM REQUIREMENTS

无菌灌装机应安装在单独的灌装车间内。

The aseptic filling machines should be installed in a separate filling room.

只有遵守该条件，空气传播的细菌数量才会下降。增加包装产品带菌可能性的因素应予以避免。如果发生下列情况，车间中的带菌可能性将会增加：

Upon complying 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:

- 安装有酸奶产品或奶粉工厂等的加工机。

- where processing machines for sour milk products or milk powder plants are installed etc.

- 安装有洗瓶机和洗箱机。

- where washing machines for bottles or crates are installed.

- 有强气流

- with strong air-currents.

- 有同其他厂区的往来交通

- with traffic to and from other plant areas.

- 有高湿度，如，装有杀菌器的车间以及在预杀菌和/或生产期间有蒸汽或热水排出的车间。

- with high humidity, such as the room where the sterilizer is installed and where you have discharges of steam or hot water during pre-sterilization and/or production periods.

- 正在进行建筑或维修工作，导致扬尘和扬土。

- Where construction or repair works are being carried out, what causes dust and dirt to appear.

灌装车间的要求FILLING ROOM REQUIREMENTS

过压Overpressure:

整个灌装车间应借助过滤的进气口保持“过压状态”。

The filling room, as a whole, should be maintained in an “overpressure condition” by means of filtered air intake.

地板Floors:

地板应铺设防滑、抗酸碱的瓷砖。所有地板/墙角应为圆形，以便清洁。排水沟也应有到出口的斜坡。Floors should be made of non-slip and acid/alkali resistant tiles. All floor/wall corners should be rounded for easy cleaning. The drain gully should also have a fall to outlet.

地板从包装机的后方到前方应有一个1.5% (1:75)的自然的“斜坡”（废水聚集在包装机的前面）。

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).

地板的排水应借助沟槽排入一个有盖子的“卫生排水沟”中。

Floor drainage is served by a gully into a covered “hygienic drain”.

墙壁Walls:

贴上一米高的瓷砖；瓷砖必须抗酸碱。

Tile to a height of minimum 1 m; the tiles must be acid/alkali resistant.

上述瓷砖应是打磨过的，以便清洁。

Above the tile-line obtain such a finish that can be easily cleaned.

所有窗台均应是倾斜的，以便清洁并防止其成为储藏架。

All window-sills should be sloped for easy cleaning and preventing their use as storage shelves.

门口Doorways：

包括包装机进气通道在内的门口通常应关闭。

Doorways including packaging material intake passages are to be normally closed.

天花板Ceiling：

天花板和天花板的结构必须防水，并易于进行干湿清洁。

Ceilings and ceiling constructions have to be waterproofed and easily accessible for the wet and dry cleaning,

通风Ventilation：

进风口Air Intake

在灌装机的后部有过滤气体沿墙壁分布。进口高度在0.3米和0.5米之间。

At the rear of the filling machine with the filtered air distributed along the walls. Intake height between 0.3 and 0.5 meters.

排气装置Exhaust：

在灌装机的前面，进风口对面墙的上面。

High up on opposite wall to the intake, in front of the filling machines.

注Note：

由于双氧水杀菌系统过多敞露在灌装车间的空气中，无菌灌装机需要在上部建筑上有计算容量为400立方米/小时的额外的排气设施。该排气量应包含在灌装车间的总体计算中。

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 more open to the filling rooms atmosphere. This exhaust volume should be included in the overall filling room calculation.

特别注意事项Special notes：

包装车间的温度应稳定在当地适合的水平上。该舒适的工作温度会随着地点的不同而有很大不同。通常该温度为18-300 C。

Packaging room temperature should be stable at the local compatible level. Such a comfortable working temperature varies considerably from place to place. Normally this compatible temperature is 18-300 C.

湿度也是一个兼容性问题；低于30%的RH为异常，高达70%时可视为舒适

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包装机散发的过氧化氢水气通常由综合排气系统连同包装机的废水一同处理。TBA/8机器为无菌室配有过压排气装置，应纳入车间的通风排气系统。

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 should be incorporated into the room’s ventilation exhaust system.

在TFA/3 和TBA/3上方，建议放置过氧化氢水气的排放装置和热负荷调节器。

Above the TFA/3 and TBA/3 it is recommended to place an exhaust for hydrogen peroxide vapor and regulation of thermal load.

物理指标Physical parameters

空气流速flow rate 0.2-0.3 m/s

正压值over pressure 2-4 mm H2O

温度temperature 15-30 ?C

湿度 humidity 30-70 %

换气频率air change frequency 10-15 次/小时10-15times/hour

注意:灌装间应保持温湿度恒定。

Remark: Pls. keep temperature and humidity of filling room stable.

卫生条件Hygienic requirement

一般用空气降落试验检查灌装车间卫生状况，菌落计数不超过30个。

Have falling out test to check the hygiene condition of filling room and total plate count should be no more than 30 cfu per 9 cm plate.

空气降落试验方法:将灭菌营养琼脂倒入直径9cm并经过灭菌处理的培养皿中,放入灌装间,打开培养皿暴露15分钟；而后,放入35±2?C恒温箱内保温两天,取出计数。

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.

如果菌落数大于30个,应该对灌装间作彻底清洗,并进行必要的特殊处理，如改进空气过滤系统、用紫外灯或乳酸消毒灌装车间。

If total plate count is more than 30 cfu, pls. clean the filling room completely and if necessary it should carry out special treatment in the filling room such us air filtration system improvement ,UV light disinfection , lactic acid disinfection and so on.