Cleaning procedures for materials entering and leaving the clean room

1. Purpose

Establish a cleaning procedure for materials entering and leaving the clean room to standardize their management.

2. Scope

Cleaning management of materials entering and leaving the clean room.

3. Responsibilities

clean area staff are responsible for this procedure.

4. Content

4.1 Procedure for materials entering the clean area

Packaging materials, etc. are transported to the unpacking room in an appropriate manner, and the outer packaging is removed. The powder on the inner packaging of the materials is wiped off with a wet rag.

(Figure 1: Materials entering the clean room)

4.1.1 If the raw materials and dust collected by the material collector have inner packaging and the inner packaging is unmarked, a label with the product name, specification, batch number and quantity and other items shall be affixed to the inner packaging, and the qualified mark shall be indicated.

4.1.2 Open the outer door of the material transfer window, put the raw materials and packaging materials into the material transfer window, close the outer door immediately, turn on the ultraviolet light, and notify the material receiving personnel in the clean area to go to the material transfer window to pick up the materials after ten minutes, or enter the clean area to pick up the materials according to the provisions of the "Cleaning Procedure for Personnel Entering and Exiting the Clean Room".

4.1.3 The material receiving personnel or the material recipient in the clean area shall open the material transfer window door, transfer the raw materials and inner packaging materials to the clean area (sealed bags can be used for sealed transportation when necessary), and immediately close the transfer window door.

4.1.4 The material receiving personnel or the material recipient in the clean area shall transport the raw materials and packaging materials in the clean area to the corresponding positions or temporarily store them in the material temporary storage room according to the needs of each position.

4.1.5 The containers in the general production area and the clean room containers used in the clean room shall not be mixed or contacted with each other.

(Figure 2: Waste leaving the clean room)

4.2 Procedure for materials and semi-finished products to leave the clean room

After the production of this batch of products is completed, the raw materials and packaging materials left over shall be sealed with a self-adhesive label on the inner packaging, indicating the product name, batch number and specifications.

4.2.1 Weight/quantity, open the material transfer window door to transfer the returned materials to the transfer window, notify the warehouse staff to wait for the return of materials, and the return material personnel shall assist the warehouse staff to put the raw materials and inner packaging materials into the corresponding outer packaging and send them back to the warehouse.

4.2.2 Semi-finished products that have been completed and used for outsourcing assembly can be directly transferred out of the clean room through the semi-finished product transfer window. When transferring out, the personnel will put the semi-finished products into the semi-finished product transfer window (clean room staff are strictly prohibited from entering the buffer zone). Five minutes later, notify the general area to receive or receive the materials.

4.3 The time regulations for materials to enter the clean room must be completed before the start of related operations

When materials and semi-finished products leave the clean room, they should follow the unified clearing principle and try to avoid multiple clearing operations.

4.4 The procedure for garbage and waste to leave the clean room

Pack and seal the garbage and waste in special garbage bags and transport them out of the clean room through the waste transfer window.