无菌灌装车间的要求

无菌灌装车间的要求

Exhibit IV: Aseptic Filli ng Room Requireme nts

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 filli ng mach ines (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 work ing en vir onment compatible with its aseptic desig n and fun cti on.

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 packag ing has a specific dime nsion in the sphere of food in dustry and must be treated accord ing to the followi ng requireme nts.

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 filli ng mach ines should be in stalled in a separate filli ng 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 compl ying with this con diti on the qua ntity of airbor ne bacteria decreases. The factors, which in crease

the possibility of non-sterility of the packed product, shall be avoided. The possibility of non-sterility

in creases in the room:

-安装有酸奶产品或奶粉工厂等的加工机。

- where process ing machi nes for sour milk products or milk powder pla nts are in stalled etc.

-安装有洗瓶机和洗箱机。

- where wash ing machi nes for bottles or crates are in stalled.

- 有强气流

- with str ong air-curre nts.

- 有同其他厂区的往来交通

- with traffic to and from other pla nt 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岀的车间。

- with high humidity, such as the room where the sterilizer is in stalled and where you have discharges of steam or hot water duri ng pre-sterilizati on an d/or producti on periods.

-正在进行建筑或维修工作，导致扬尘和扬土。

- Where con structi on 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 in take.

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。排水沟也应有到岀口的斜坡。

Floors should be made of non-slip and acid/alkali resista nt tiles. All floor/wall cor ners should be roun ded for easy clea ning. 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 n atural “ fall 1 o(1:75) preferably from the back to the front of the packagi ng

mach ine (waste water exits are located towards the front of the packag ing machi ne).

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 dra in age is served by a gully into a covered “ hygie nic dra in ” .

墙壁Walls :

贴上一米高的瓷砖；瓷砖必须抗酸碱。

Tile to a height of mini mum 1 m; the tiles must be acid/alkali resista nt.

上述瓷砖应是打磨过的，以便清洁。

Above the tile-l ine obta in such a finish that can be easily clea ned.

所有窗台均应是倾斜的，以便清洁并防止其成为储藏架。

All win dow-sills should be sloped for easy clea ning and preve nti ng 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 in cludi ng packagi ng material in take passages are to be n ormally 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 clea ning,

通风Ventilation :

进风口Air In take

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 filli ng mach ine with the filtered air distributed along the walls. In take height betwee n 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 in take, in front of the filli ng mach in es.

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