无需采用处理用器具进行盛装无需处理用器具盛装D、C级洁净区一般物品无需

There is no need to use processing equipment for packaging. <br>No processing equipment is required to hold general items in <br>Class D and C clean areas. No need to process Class C clean area equipment in general production areas : purifying air conditioning systems and ozone generators. Liquid: formaldehyde (37%), purified water. According to the size of the clean area, the amount of formaldehyde is based on commercially available products with a concentration of 37%. The dosage area is 3000ml, the cleaning area is 4000ml, the filling area is 2500ml, and the capping area is 2000ml. The operator promptly fills in the "Environmental disinfection account of the clean room (area) of the preparation production line in the seventh workshop" F-SOP-37-3-0-004-01. Attachment 1 Fumigation pot layout in the filling area Attachment 2 Fumigation pot layout in the capping area Clean room (area) environmental disinfection ledger Clean room (area) formaldehyde fumigation and disinfection records Applicable scope: suitable for operators and outsiders entering and exiting the seventh workshop preparation The general production area of ​​the production line (CNC area), cleaning area (level D), liquid distribution area (level C), capping area (level C), aseptic area (level B). External personnel: refer to personnel outside the company and personnel outside the preparation production line of the seven workshops within the company (excluding QA personnel and equipment maintenance personnel). Enter the entrance hall on the first floor from the west gate of the No. 3 production building and arrive at the shoe changing area in the hall. Enter the buffer room and change shoes, hands and glasses. Choose the appropriate size disposable sterile gloves (no powder) and wear them; after the visitors leave the peripheral corridor of the technical room, go downstairs and cross the corridor to the shoe changing area in the hall of No. 3 production building, and sit on the stainless steel shoe cabinet facing the inside. Turn to the outside, take off the shoe covers and put them in the special trash can for shoe covers, and leave the production building No. 3.<br><br><br><br><br><br><br><br><br><br><br><br><br><br><br><br><br><br><br>If you still need to enter the area on the same day, fold the removed clean clothes, put them in the corresponding numbered bag, hang them on the clothes storage rack, and wear them again; if you do not enter the same day, put the removed clean clothes into the designated Put the lid on the clean clothes box to be cleaned at the location. <br>Back to the technical room, go downstairs and cross the corridor to the lobby of the No. 3 production building, take off the outer slippers and put on the outdoor shoes, and leave the No. 3 production building. <br>There are 10 people in the liquid dispensing area, 15 people in the cleaning area, 12 people in the aseptic area, and 8 people in the capping area. <br>The personnel who enter the preparation production line of the seventh workshop <br>change shoes (peripheral slippers) and <br>change shoes (general area shoes ) on the third floor. <br>Cleaner clothes and shoes in the clean area. <br>Materials: clean rags, drinking water, purified water, disinfectant, laundry detergent, hand sanitizer, degreasing Agent. <br>Materials and materials that need to be transferred to Class C and D clean areas should be wiped with disinfectant in the outer clean room, and then transferred to the logistics air lock for self-cleaning. The materials and materials can be taken out after the logistics air lock is self-cleaning for 30 minutes. <br>When paper items (recorded on site) enter the C and D clean area, they need to pass through the air lock for 30 minutes and then pass in. <br>Materials and materials resistant to damp and heat sterilization, such as semi-finished products preparation, filling containers, B-level area cleaning appliances, batch records, etc.: enter the B-level area after being sterilized by damp heat at 121°C. <br>Those that cannot tolerate damp heat sterilization, such as petri dishes, rubber stopper sterile bags, etc.: Sterilize materials and materials through the VHP transfer window, and then enter the Class B clean area. <br>The materials and materials that cannot be sterilized by moist heat and VHP are placed in the UV lamp transfer window, and the UV lamp is turned on for 30 minutes and then enters the B-level area. <br>The <br>items in the outgoing clean area (Class C, D) do not need to be processed directly from the UV lamp transfer window, VHP transfer window and pulse vacuum sterilizer to the cleaning area. <br>Transfer to logistics, air lock, self-cleaning, <br>non - toxic materials transfer out

No handling equipment is required for loading<br>No need to handle appliances<br>D, C-class clean area<br>General items<br>No processing required<br>General production area<br>Class C clean area<br>Equipment: purifying air conditioning system, ozone generator.<br>Liquid: formaldehyde (37%), purified water.<br>According to the size of the clean area space, formaldehyde dosage to the commercial 37% concentration of commodity meters, distribution area 3000ml, cleaning area 4000ml, filling area 2500ml, rolling area 2000ml.<br>Operators fill in the "seven workshop preparation production line clean room (area) environmental disinfection account" F-SOP-37-3-0-004-01.<br>Annex 1 A map of the smoked pot cloth in the filling area<br>Attachment 2 Cover area smoked pot cloth dot map<br>Clean room (area) environmental disinfection ledger<br>Clean room (area) formaldehyde fumigation and disinfection records<br>Scope of application: suitable for operators and foreign personnel in and out of the seven workshop preparation production line general production area (CNC zone), cleaning area (class D), distribution area (C grade), rolling cover area (C grade), sterile area (class B).<br>Foreign personnel: refers to people outside the Company and personnel outside the production line of seven workshop preparations within the Company (not including QA personnel and equipment maintenance personnel).<br>From the west gate of the 3rd production building into the first floor foyer, to the lobby more shoes.<br>Enter the buffer room, more shoes, hands, glasses cleaning.<br>Choose the right size of disposable sterile gloves (powder-free) to wear well;<br>After leaving the peripheral corridor of the technical room, the foreign visitors went downstairs through the corridor to reach the 3rd production building hall more shoes, facing the inside sitting on the stainless steel shoe cabinet, turned to the outside, took off the shoe cover into the shoe cover special garbage can, out of the 3rd production building.<br>If the same day still need to enter the area, take off the clean clothes stacked, put in the corresponding number of bags, hanging on the clothes storage rack, next time to wear;<br>Back in the technical room, downstairs through the corridor to the 3rd production building hall, take off the peripheral slippers back to the outdoor shoes, out of the 3rd production building.<br>10 people in the distribution area, 15 people in the cleaning area, 12 people in the sterile area and 8 people in the rolling area.<br>Enter the seven workshop preparation production line personnel<br>More shoes (peripheral slippers)<br>Change shoes on the third floor (general area shoes)<br>Cleaner clothes, clean area shoes<br>Materials: clean cloth, drinking water, purified water, disinfectant, laundry detergent, hand sanitizer, de-oiling agent.<br>Materials, materials need to be transferred to C, D-level clean area, in the outer cleaning with disinfection liquid wipe, into the logistics gas lock self-purification, logistics gas lock from the net 30 minutes later, before the materials, materials can be removed.<br>Paper items (on-site recording) into the C, D-class clean area, through the logistics gas lock purification after 30 minutes.<br>Moisture-resistant materials and materials, such as semi-finished preparation, filling containers, B-grade cleaning utensils, batch records, etc.: after 121 degrees C wet heat sterilization into the B-zone.<br>Can not withstand wet and hot sterilization, such as petri dishes, plug sterile bags, etc. : through the VHP transfer window to sterilize materials, materials, and then into the B-class clean area.<br>Can not be wet and hot sterilization and VHP sterilization of materials, materials put in the ultraviolet light transfer window, turn on the UV lamp after 30 minutes into the B-zone.<br>Outgoing Clean Zones (C, D)<br>Items do not need to be processed directly from the UV light transfer window, VHP transfer window and pulsation vacuum sterilizer to the cleaning area.<br>Transfer to logistics gas lock self-purification<br>Non-toxic items are transferred out

There is no need to use handling equipment for packing<br>There is no need to handle the container<br>D. Class C clean area<br>General items<br>No need to deal with it<br>General production area<br>Class C clean area<br>Equipment: purification air conditioning system, ozone generator.<br>Liquid: formaldehyde (37%), purified water.<br>According to the space size of the clean area, the amount of formaldehyde in the commercial products with 37% concentration is 3000ml in the liquid preparation area, 4000ml in the cleaning area, 2500ml in the filling area and 2000ml in the capping area.<br>The operator should fill in the "environmental disinfection account of the clean room (area) of the seventh workshop preparation production line" f-sop-37-3-0-004-01.<br>Annex 1 layout of smoked pot in filling area<br>Annex 2 layout of fumigation pot in capping area<br>Clean room (area) environmental disinfection account<br>Record of formaldehyde fumigation and disinfection in clean room (area)<br>Scope of application: it is suitable for operators and outsiders to enter and leave the general production area (CNC area), cleaning area (grade D), solution preparation area (grade C), capping area (grade C) and aseptic area (Grade B).<br>External personnel: refers to the personnel outside the company and the personnel outside the seven workshop preparation production line within the company (excluding QA personnel and equipment maintenance personnel).<br>Enter the hall on the first floor from the west gate of No.3 production building and arrive at the shoe changing place of the hall.<br>Enter the buffer room, change shoes, wash hands and glasses.<br>Choose suitable size disposable sterile gloves (powder free) and wear them well;<br>After leaving the peripheral corridor of the technical room, the visitors go downstairs and cross the corridor to the shoe changing place in the hall of No.3 production building. Facing the inside, they sit on the stainless steel shoe cabinet, turn to the outside, take off the shoe cover and put it into the special garbage bin for shoe cover, and then go out of the No.3 production building.<br>If you still need to enter the area on the same day, fold the clean clothes off and put them into the bags with corresponding numbers, hang them on the clothes storage rack and wear them again next time; if you do not enter the area on the same day, put the clothes off into the clean clothes box to be cleaned at the designated place, and cover them.<br>Go down the hallway to room 3, get out of the building, take off your shoes and go back to the production hall.<br>There were 10 people in the liquid preparation area, 15 in the cleaning area, 12 in the sterile area and 8 in the capping area.<br>Personnel entering the preparation production line of No.7 workshop<br>Changing shoes (outer slippers)<br>Shoes change on the third floor (general area shoes)<br>Cleaner clothes, clean area shoes<br>Materials: clean dishcloth, drinking water, purified water, disinfectant, detergent, hand sanitizer, degreaser.<br>If the materials and materials need to be transferred to the C and D clean areas, they should be wiped with disinfectant in the external cleaning room, and then transferred to the logistics gas lock for self-cleaning. The materials and materials can be taken out 30 minutes after the self-cleaning of the logistics gas lock.<br>When paper articles (on-site records) enter class C and D clean areas, they need to be purified by logistics gas lock for 30 minutes before they are transferred in.<br>Materials and materials resistant to hygrothermal sterilization, such as preparation of semi-finished products, containers for filling, cleaning appliances in class B area, batch records, etc., shall enter the B-class area after being sterilized at 121 ℃.<br>Those that can't tolerate heat and humidity sterilization, such as culture dish, rubber plug sterile bag, etc.: sterilize materials and materials through VHP transmission window, and then enter class B clean area.<br>Materials and materials that cannot be sterilized by moist heat or VHP should be placed in the transmission window of ultraviolet lamp. After the ultraviolet lamp is turned on for 30 minutes, it will enter the class B area.<br>Outgoing clean area (grade C, d)<br>The articles need not to be handled, and they are directly transferred from UV lamp transfer window, VHP transfer window and pulsating vacuum sterilizer to the cleaning area.<br>Gas lock self purification<br>Transfer of non-toxic substances<br>