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.