工作服管理规程
Workwear management procedures

Record Management Procedure

目录Contents

1 目的Purpose 4
1 Purpose 4

2 适用范围Scope 4
2 Scope 4

3 职责Responsibilities 4
3 Responsibilities 4

4 缩写/定义 Abbreviations/Definitions 5
4 Abbreviations/Definitions 5

5 程序procedure 6
5 Procedure 6

5.1 记录的种类Types of Records 6
5.1 Types of Records 6

5.2 记录的设计Record Design 6
5.2 Record Design 6

5.3 记录的格式与编号原则Format and Numbering Principle of Records 6
5.3 Format and Numbering Principle of Records 6

5.4 空白记录样张的管理Management of Blank Record Sheets 7
5.4 Management of Blank Record Sheets 7

5.5 记录的起草、审核和批准Record Drafting, Review and Approval 7
5.5 Record Drafting, Review and Approval 7

5.6 记录的复印、发放和归档Copying, Issuing and Archiving of Records 7
5.6 Copying, Issuing and Archiving of Records 7

5.7 记录保留时间Record Retention Time 13
5.7 Record Retention Time 13

5.8 记录的填写Record Filling 14
5.8 Record Filling 14

5.9 记录的保存Record Keeping 22
5.9 Record Keeping 22

5.10 记录的销毁Destruction of Records 22
5.10 Destruction of Records 22

5.11 记录外发控制Record Outgoing Control 23

6 附件Attachments 23
6 Attachments 23

7 相关文件Related documents 24

8 版本历史Version History 24
Version History 24

目的Purpose
Purpose

明确公司对工作服的管理要求，确保工作服的使用能够保证人员不对药品和环境产生污染，并保护人员不受药品和环境的伤害。
Clarify the company's management requirements for work clothes, ensure that the use of work clothes can ensure that personnel do not pollute drugs and the environment, and protect personnel from drugs and the environment.

In order to standardize the design, release, storage and destruction of records, to ensure the feasibility, authenticity, validity, controllability and traceability of records, the document is formulated.

适用范围Scope
Scope of application: Scope

适用于公司生物车间、规范生物车间清洁、灭菌、使用及回收的管理。
It is suitable for the management of cleaning, sterilization, use and recycling of the company's biological workshop and standardized biological workshop.

It is applicable to the management of all GMP related records of biological products of Lepu Pharmaceutical Co., LTD.

职责Responsibilities
Responsibilities

3.1生物车间
3.1 Biological workshop

3.1.1负责本文件的起草和修订，并监督本部门的执行。
3.1.1 Responsible for the drafting and revision of this document, and supervise the implementation of the department.

3.1.2负责按要求使用、清洗、灭菌和存放洁净工作服。
3.1.2 Responsible for using, cleaning, sterilizing and storing clean work clothes as required.

3.1.3负责洁净工作服的发放、回收及销毁。
3.1.3 Responsible for the distribution, recycling and destruction of clean work clothes.

3.1.4负责洁净服的编号。
3.1.4 Responsible for the numbering of clean clothing.

3.2质量保证部
3.2 Quality Assurance Department

3.2.1负责对与产品接触人员工作服的管理内容进行审核；
3.2.1 Responsible for reviewing the management content of the work clothes of the personnel in contact with the product;

3.2.2负责监督车间洁净工作服的管理；
3.2.2 Responsible for supervising the management of clean work clothes in the workshop;

3.2.3负责洁净工作服供应商审计负责对外提供相关记录。
3.2.3 Responsible for the audit of clean work clothes suppliers, and responsible for providing relevant records to the outside world.

3.3PC采购部
3.3 PC Purchasing Department

3.3.1负责工作服的采购。
3.3.1 Responsible for the procurement of work clothes.

Data: refers to the information generated in the activities of drug development, production, management and use that reflects the implementation of the activities, including: words, numbers, symbols, images, audio, pictures, maps, bar codes, etc.

4 缩写或定义Abbreviation and definitions

无N/A。
No N/A.

5 程序Procedure
5 Procedure

5.1工作服的管理要求
5.1 Management requirements for work clothes

5.1.1 使用部门均需根据所在工作区域的操作和防护要求，规范各区域操作人员工作服的着装。
5.1.1 The user department shall standardize the clothing of the operators in each area according to the operation and protection requirements of the working area.

5.1.2 进入控制区的操作人员使用的工作服，根据操作人员所在工作区域的要求，分为：制剂A线B级、制剂A线C级、制剂B线B级、制剂B线C级、生产下游D级、生产下游C级（粗纯、精纯）、生产上游C级、生产上游D级、D级及CNC区的工作服。
5.1.2 The work clothes used by the operator entering the control area are divided into: preparation A line B, preparation A line C, preparation B line B, preparation B line C, preparation B line C, according to the requirements of the operator's work area Production downstream D-grade, production downstream C-grade (crude pure, polished), production upstream C-grade, production upstream D-class, D-grade and CNC area workwear.

5.1.3工作服的准备必需有余量，确保必要的换洗要求，如发现破损及时更换。
5.1.3 There must be a margin in the preparation of work clothes to ensure the necessary change of washing requirements, and replace them in time if they are found to be damaged.

5.1.4 工作服包括在洁净区、一般区使用的对人员进行防护的洁净服和其他防护用品包括但不限于：洁净衣、洁净鞋、小白鞋、袜套、帽子、口罩、手套，护目镜等。
5.1.4 Work clothes include clean clothes and other protective equipment used in clean areas and general areas to protect personnel, including but not limited to: clean clothes, clean shoes, small white shoes, sock covers, hats, masks, gloves, goggles, etc.

5.2工作服的基本着装要求
5.2 Basic dress code for work clothes

5.2.1 操作人员穿着工作服应与所从事的工作和空气洁净度级别要求相适应，各车间不得混用，穿着方式应当能够满足保护产品和人员的要求。
5.2.1 The work clothes worn by the operators should be suitable for the work they are engaged in and the requirements of the air cleanliness level, and the workshops shall not be mixed, and the wearing method shall be able to meet the requirements of protecting products and personnel.

5.2.2工作服尺寸应适中，穿着舒适，不妨碍动作。
5.2.2 The size of the work clothes should be moderate, comfortable to wear, and not hinder the movement.

5.2.3工作服号码应齐全，保证工作人员穿着和体。
5.2.3 The number of work clothes should be complete to ensure that the staff is dressed and physical.

5.3工作服的发放、领用和销毁
5.3 Distribution, receipt and destruction of work clothes

5.3.1 新工作服按尺码及编号进行分类，分装在袋中。
5.3.1 New uniforms are sorted by size and number and packed in bags.

5.3.2 各部门应指定人员进行工作服发放及回收，建立《工作服灭菌记录》（SOP-MF-PR-052-A02）、《工作服清洗次数统计记录》（SOP-MF-PR-052-A03）、《工作服清洗记录》（SOP-MF-PR-052-A01） 和《工作服灭菌次数统计记录》（SOP-MF-PR-052-A04），对工作服进行管理。无菌长靴只 统 计清洗次数，灭菌次数不进行统计；CNC区的工作服回收、清洗、发放不进行记录。
5.3.2 Each department shall designate personnel to distribute and recycle work clothes, and establish the "Sterilization Record of Work Clothes" (SOP-MF-PR-052-A02), "Statistical Record of Work Clothes Cleaning Times" (SOP-MF-PR-052-A03), "" Workwear Cleaning Record (SOP-MF-PR-052-A01) and "Workwear Sterilization Statistical Record" (SOP-MF-PR-052-A04) to manage workwear. Sterile boots are only counted for the number of cleanings, and the number of sterilizations is not counted; There is no record of the collection, cleaning, and distribution of work clothes in the CNC area.

5.3.3 破损的工作服，以旧工作服换取新工作服，避免破损工作服出现在现场被误使用。
5.3.3 Replace the old work clothes with new work clothes to avoid the damaged work clothes from being misused on site.

5.3.4 收回后的破损工作服，需从腰部剪断工作服进行销毁，并填写《工作服销毁记录》（SMP-MF-029-A02），防止再次使用。
5.3.4 After the repossession of damaged work clothes, cut the work clothes from the waist for destruction, and fill in the "Work Clothes Destruction Record" (SMP-MF-029-A02) to prevent reuse.

5.4工作服的洗涤、干燥、灭菌
5.4 Washing, drying and sterilization of work clothes

5.4.1 洗涤环境级别：生产上游、生产下游车间、制剂A线区域工作服应在1081洗衣间洗涤。制剂B线区域工作服在P309洗衣间洗涤。CNC区工作服及工作鞋在1094洗衣间洗涤。
5.4.1 Washing environment level: The work clothes in the upstream of production, downstream production workshop, and preparation line A area should be washed in the 1081 washroom. Preparations for B-line area overalls are washed in the P309 laundry room. CNC area overalls and shoes are washed in the 1094 laundry room.

5.4.2 在1049洗衣间，生产上游、生产下游及其不同级别的工作服和同级别除病毒前后的洁净服，切勿混在一起清洗，精纯间工作服单独清洗，以防交叉污染，工作服非正常污染时，应立即更换、清洗。
5.4.2 In the 1049 laundry room, the upstream of production, the downstream of production and their different levels of work clothes and the same level of clean clothes before and after virus removal should not be mixed and cleaned, and the work clothes in the pure room should be cleaned separately to prevent cross-contamination. When the work clothes are abnormally polluted, they should be replaced and cleaned immediately.

5.4.3 无菌长靴及袜套清洗规则参考洁净服。无菌长靴及袜套第一次使用滚筒洗衣机清洗，不做记录，第二次清洗使用隔离双扉洗脱烘一体机清洗后，传入2020整衣灭菌间。
5.4.3 Cleaning rules for sterile boots and socks refer to clean clothes. Sterile boots and socks are cleaned in a drum washing machine for the first time without recording, and the second cleaning is cleaned with an isolated double-door elution and drying machine, and then passed into the 2020 whole clothes sterilization room.

5.4.4 洗涤剂：饮用水、纯化水（C、D级、B级）、洗衣液。
5.4.4 Detergents: drinking water, purified water (C, D, B), laundry detergent.

5.4.5 CNC区工作服每周2次发放清洗，CNC区的工作鞋每周清洗一次，期间如发现脏了随时更换清洗；CNC区发放的工作服和工作鞋未使用过的不进行清洗。生产部门和无菌长靴每天使用后清洗、干燥，D级洁净服一个月进行一次灭菌处理，未使用过的不进行清洗。C级洁净服和无菌长靴，原液车间的每天使用后清洗、干燥，制剂A线和制剂B线的每次用后进行清洗，每周灭菌一次，未使用过的不进行清洗。若洁净服和无菌长靴在灭菌效期内未使用，应在使用前再次灭菌。
5.4.5 CNC area work clothes are distributed and cleaned twice a week, CNC area work shoes are cleaned once a week, and if they are found dirty, they can be replaced and cleaned at any time during the period; Unused work clothes and work shoes issued in the CNC area will not be cleaned. The production department and sterile boots are cleaned and dried every day after use, and the D-level clean clothes are sterilized once a month, and the unused ones are not cleaned. Class C clean clothes and sterile boots, cleaned and dried after daily use in the drug substance workshop, cleaned after each use of preparation A line and preparation B line, sterilized once a week, and unused ones are not cleaned. If the gown and sterile boots are not used within the sterilization period, they should be sterilized again before use.

5.4.6 无菌长靴和袜套分两次清洗，采取先使用滚筒式洗衣干洗机清洗，再使用隔离双扉洗脱烘一体机清洗干燥；第一次清洗时切勿混在一起，可以在第二次混合清洗，但是生产制剂的无菌长靴和袜套两次清洗均不可混洗，且制剂B线C级、B级的工作服应使用不同的洗衣设备进行洗涤。
5.4.6 Sterile boots and socks should be cleaned twice, first with a drum washer-dryer, and then with an isolated double-front elution and dryer for cleaning and drying; Do not mix together during the first cleaning, you can mix and clean in the second time, but the sterile boots and socks for the production of preparations should not be mixed and washed twice, and the preparation B line C and B class work clothes should be washed with different washing equipment.

5.4.7 洁净服清洗完后整衣装袋放入收纳箱，收纳箱悬挂或者贴《物品清洁状态牌》（ SMP-MF-014-A06）。灭菌后的洁净服放入收纳盒，收纳盒悬挂或贴《灭菌物品标签》（SMP-MF-014-A04），根据各自部门的相关SOP规定要求写明洁净服的灭菌有效期至，洁净服需要灭菌时，需要清洁后尽快转移灭菌。
5.4.7 After the clean clothes are cleaned, the whole clothes are bagged and put into the storage box, and the storage box is hung or pasted with the "Cleaning Status Card" (SMP-MF-014-A06). Put the sterilized clean clothes into the storage box, hang or affix the "Sterilized Goods Label" (SMP-MF-014-A04) in the storage box, and write the sterilization validity period of the clean clothes according to the relevant SOP requirements of the respective departments, and when the clean clothes need to be sterilized, they need to be transferred for sterilization as soon as possible after cleaning.

灭菌时的装载数量应符合验证的数据要求。
The loading quantity at the time of sterilization should meet the data requirements of the validation.

5.4.8 洗涤前要检查工作服磨损、破损情况，按需要进行更换。
5.4.8 Check the wear and tear of the overalls before washing, and replace them as necessary.

5.4.9 清洗后，灭菌前整理衣环境级别：B级工作服整理需在A级单向层流保护下进行。C级和D级洁净服的整理环境要求至少为D级环境下A级单向层流保护下进行。整理后， B级、生产上下游C级将洁净工作服按编号配衣并放入整理袋内后（B级洁净服配衣后直接放入呼吸袋），放入呼吸袋内进行灭菌。上下游D级洁净区与制剂A线C级和制剂B线C级使用的洁净服，需要将洁净工作服按编号配衣并放入整理袋内进行灭菌。衣服的折叠方式要便于更衣。
5.4.9 After cleaning, before sterilization, the finishing of clothing environmental level: Class B work clothes should be finished under the protection of Class A unidirectional laminar flow. The finishing environment of Class C and Class D clean clothing is required to be at least Class A unidirectional laminar flow protection in Class D environment. After finishing, grade B and grade C in the upstream and downstream of production will match the clean work clothes according to the number and put them into the finishing bag (after the B grade clean clothes are coated directly into the breathing bag), put them into the breathing bag for sterilization. The clean clothes used in the upstream and downstream Class D clean areas and the preparation A line C and the preparation B line C need to be coated according to the number and put into the sorting bag for sterilization. Clothes should be folded in such a way that they are easy to change.

5.4.10 已清洗和灭菌的洁净服，为避免保存及传递过程中受到污染，需要使用带盖收纳盒进行转运。
5.4.10 Cleaned and sterilized garments need to be transported in a storage box with a lid in order to avoid contamination during storage and delivery.

5.4.11工作服清洗或者灭菌干燥后，发放至相应区域的更衣室。
5.4.11 After the work clothes are washed or sterilized and dried, they are distributed to the changing room in the corresponding area.

5.4.11.1 生产上游D级洁净服和无菌长靴进出更衣室路线：
5.4.11.1 Production upstream Class D clean clothes and sterile boots in and out of the locker room route:

进：在1049洗衣间通过隔离双扉洗脱烘一体机清洗完衣物后，转移至1047整衣灭菌间，整衣灭菌后通过1047的传递窗至1111走廊转移至1043更鞋间，再转移至1114更衣间。
Enter: After washing the clothes in the 1049 laundry room through the isolated double-door elution and drying machine, transfer them to the 1047 whole clothes sterilization room, and after the whole clothes are sterilized, go to 1111 through the transfer window of 1047The corridor was moved to the 1043 locker room and then to the 1114 locker room.

出：从1114更衣间转移至1043更鞋间，出门通过1111走廊转移至1049洗衣间。
Out: Transfer from the 1114 locker room to the 1043 locker room, and go out through the 1111 corridor to the 1049 laundry room.

5.4.11.2生产上游C级洁净服和无菌长靴进出更衣室路线：
5.4.11.2 Production of upstream C-level clean clothes and sterile boots in and out of the locker room route:

进：在1049洗衣间通过隔离双扉洗脱烘一体机清洗完衣物后，转移至1047 整衣灭菌间，整衣灭菌后通过1111走廊转移至1005更鞋间，再转移至1007更衣间。
Enter: After washing the clothes in the 1049 laundry room through the isolated double elution and drying machine, transfer them to the 1047 whole clothes sterilization room, and transfer the whole clothes to the 1111 corridor after sterilization1005 changing room, then transferred to 1007 changing room.

出：从1007更衣间转移至1005更鞋间，出门通过1111走廊转移至1049洗衣间。
Out: Move from the 1007 locker room to the 1005 locker room, and go out through the 1111 corridor to the 1049 laundry room.

5.4.11.3 生产下游D级洁净服和无菌长靴进出更衣室路线：
5.4.11.3 Production of downstream Class D clean clothes and sterile boots in and out of the locker room:

进：在1049洗衣间通过隔离双扉洗脱烘一体机清洗完衣物后，转移至1047整衣灭菌间，整衣灭菌后通过1110走廊转移至1050缓冲间，再转移至1051更衣间；
Enter: After washing the clothes in the 1049 laundry room through the isolated double elution and drying machine, transfer to the 1047 whole clothes sterilization room, and transfer the whole clothes to 1050 through the 1110 corridor after sterilizationbuffer room, then transferred to 1051 locker room;

出：从1051更衣间的传递窗转移至1049洗衣间。
Out: Moved from the transfer window in the 1051 locker room to the 1049 laundry room.

5.4.11.4 生产下游C级洁净服和无菌长靴进出粗纯间更衣室路线：
5.4.11.4 Production of downstream C-level clean clothes and sterile boots in and out of the coarse pure room locker room route:

进：在1049洗衣间通过隔离双扉洗脱烘一体机清洗完衣物后，转移至1047整衣灭菌间，整衣灭菌后通过1111走廊转移至1021更鞋间，通过更鞋间转移至1022更衣间；
Enter: After washing the clothes in the 1049 laundry room through the isolated double elution and drying machine, transfer them to the 1047 whole clothes sterilization room, and transfer the whole clothes to 1021 through the 1111 corridor after sterilizationThe changing room is transferred to the 1022 changing room through the changing room;

出：从1022更衣间转移至1021更鞋间，出门通过1111走廊转移至1049洗衣间。
Out: Move from 1022 locker room to 1021 shoe room, and go out through 1111 corridor to 1049 laundry room.

5.4.11.5 生产下游C级洁净服和无菌长靴进出精纯间更衣室路线：
5.4.11.5 Production of downstream C-level clean clothes and sterile boots in and out of the dressing room route of the pure room

进：在1049洗衣间通过隔离双扉洗脱烘一体机清洗完衣物后，转移至1047整衣灭菌间，整衣灭菌后通过1111走廊转移至1028更鞋间，通过更鞋间转移至1029更衣间；
Enter: After washing the clothes in the 1049 laundry room through the isolated double-door elution and drying machine, transfer them to the 1047 whole clothes sterilization room, transfer the whole clothes to the 1028 changing room through the 1111 corridor after sterilization, and transfer them to the 1029 changing room through the changing room;

出：从1029更衣间转移至1028更鞋间，出门通过1111走廊转移至1049洗衣间。
Out: Move from the 1029 locker room to the 1028 locker room, and go out through the 1111 corridor to the 1049 laundry room.

5.4.11.6 制剂A线B级洁净服和无菌长靴进出更衣室路线：
5.4.11.6 Preparation A line B clean gowns and sterile boots in and out of the locker room route:

进：从洗衣间1081洗完到整衣灭菌间1080整理，运到洗灭中心间1075进行灭菌，从无菌接收间2 1072卸，经B级走廊1070到1066进更缓冲间到1067二更间和1068一更间；
Enter: from the laundry room 1081 to the whole clothes sterilization room 1080 finishing, transport to the washing center room 1075 for sterilization, unload from the sterile receiving room 2 1072, through the B-level corridor 1070 to 1066 into the buffer room to the 1067 second shift room and 1068 the first shift room;

出：从1064退更间到1065更鞋间到CNC到1081洗衣间。
Out: from 1064 to 1065 to CNC to 1081 laundry.

5.4.11.7 制剂A线C级洁净服进出更衣室路线：
5.4.11.7 Preparation A line C class clean clothes in and out of the locker room route:

进：从洗衣间1081洗完到整衣灭菌间1080卸整理灭菌到1076C级走廊到1077缓冲间到1078更衣间；
Enter: from the laundry room 1081 to the whole laundry sterilization room 1080 unloading and sterilization to the 1076C corridor to the 1077 buffer room to the 1078 dressing room;

出：1078更衣间到1079更鞋间到1079传递窗到1081洗衣间。
Out: 1078 dressing room to 1079 changing shoe room to 1079 pass window to 1081 laundry room.

5.4.11.8 制剂B线B级洁净服和无菌长靴进出更衣室路线：
5.4.11.8 Preparation B line B class clean clothes and sterile boots in and out of the locker room:

进：从P306洗衣间洗完到P326整衣间整衣后，运到P331灭菌间进行灭菌， 在P342接收间卸载后，经P341 B级走廊到P340进更缓冲间到P339二更间和P338一更间。
Enter: After washing from the P306 laundry room to the P326 dressing room, transport it to the P331 sterilization room for sterilization, unload it in the P342 receiving room, and go through the P341 B corridor to the P340 buffer room to the P339 second shift room and P338 first shift room.

出：从P344退更间到P337 B级更鞋间到P305 CNC走廊到P306洗衣间。
Out: From P344 to P337 B-level shoe room to P305 CNC corridor to P306 laundry room.

5.4.11.9 制剂B线C级洁净服和无菌长靴进出更衣室路线：
5.4.11.9 Preparation B line C clean clothes and sterile boots in and out of the locker room:

进：从洗衣间P306洗完到整衣间P326整衣后，运到灭菌间P331进行灭菌，在进料门卸载后，经C级走廊，通过缓冲间P324到更衣间P323。
Enter: After washing from the laundry room P306 to the whole wardrobe P326, it is transported to the sterilization room P331 for sterilization, and after unloading at the feed door, it passes through the C-level corridor through the buffer room P324 to the dressing room P323.

出：从P323更衣间到P322更鞋间到P305 CNC走廊到P306洗衣间。
Out: From P323 to P322 to P305 CNC corridor to P306 laundry.

5.4.11.10 CNC区工作服进出更衣室路线：
5.4.11.10 Routes for entering and exiting the locker room in CNC area workwear:

进：从1094洗衣间通过1111走廊转移至1095洗手间，再分发至1096或1097更衣间；
Enter: Transfer from laundry room 1094 to restroom 1095 through corridor 1111 and then distribute to locker room 1096 or 1097;

出：从1097或1096更衣间转移至1095房间，通过1111走廊到1094洗衣间。
Out: Transfer from locker room 1097 or 1096 to room 1095 and through hallway 1111 to laundry room 1094.

制剂B线进：从1094洗衣间通过1111走廊转移至1116物料交接，从货梯转移至三楼P319物料接收间，经P305 CNC走廊到P304洗手间，再分发至P302或P303更衣间。
Preparation B line in: transfer from the 1094 laundry room to the 1116 material handover through the 1111 corridor, transfer from the freight elevator to the P319 material receiving room on the third floor, go through the P305 CNC corridor to the P304 toilet, and then distribute to the P302 or P303 locker room.

制剂B线出：从P302或P303更衣间转移至P304洗手间，通过P305 CNC走廊转移至P319物料接收间，经货梯运到一层1116物料交接处，经1111走廊到1049洗衣间。
Preparation B line out: transfer from P302 or P303 locker room to P304 toilet, transfer to P319 material receiving room through P305 CNC corridor, transport to 1116 material handover on the first floor by freight elevator, and go to 1049 laundry room through corridor 1111.

5.5工作服使用
5.5 Use of work clothes

5.5.1 不同洁净级别的工作服不能混用。不同洁净级别的工作服尽量在颜色上要有区分，降低使用和清洗过程中发生混淆的风险。
5.5.1 Workwear with different levels of cleanliness cannot be mixed. Uniforms of different cleanliness levels should be coloured differently as much as possible to reduce the risk of confusion during use and cleaning.

5.5.2 工作服应编号。工作服编号原则：区域代码+流水号
5.5.2 Workwear shall be numbered. The principle of work clothes numbering: area code + serial number

5.5.3 洁净鞋应编号。洁净鞋编号原则：区域代码+洁净鞋尺码+流水号
5.5.3 Clean shoes should be numbered. Clean shoe numbering principle: area code + clean shoe size + serial number

5.5.4 区域代码：
5.5.4 Area Code:

5.5.5 流水号：使用三位流水号，从001开始；
5.5.5 Serial number: use three-digit serial number, starting from 001;

例如：生产下游车间精纯洁净区第一套洁净服：MF02J001；生产下游车间精纯洁净区第一件洁净鞋：MF02J40001
For example: the first set of clean clothes in the refined clean area of the downstream production workshop: MF02J001; The first clean shoe in the refined clean area of the downstream workshop of production: MF02J40001

5.5.6洁净鞋整理袋印鞋子尺码，以表明包装袋内鞋子的信息，避免开袋查找。
5.5.6 Clean shoes are printed on the bag to indicate the information of the shoes in the bag and avoid opening the bag to find.

5.5.7工作服销毁后，工作服编号不再重复使用。
5.5.7 After the work clothes are destroyed, the work clothes number will not be reused.

5.5.8洁净区每日需准备备用洁净服供外来人员使用。
5.5.8 The clean area needs to prepare spare clean clothes every day for outsiders to use.

5.6工作服样式
5.6 style of work clothes

5.6.1工作服样式图
5.6.1 Work clothes style drawing

区域名称 The name of the region	工作服 smock	衣服款式 Clothing style
生产上游车间D级洁净区 Class D clean area in the upstream workshop of production	粉色分体服、工作鞋、脚套、一次性口罩、一次性手套、帽子、一次性头套， Pink split suits, work shoes, foot covers, disposable masks, disposable gloves, hats, disposable head covers,	（衣服款式示例，一次性物品可不仅限于图片款式） (Examples of clothing styles, disposable items may not be limited to picture styles)
生产下游车间D级洁净区 Class D clean area in the downstream workshop of production	海蓝色分体服、工作鞋、脚套、一次性口罩、一次性手套、一次性帽子、帽子 Ocean blue split suit, work shoes, foot covers, disposable masks, disposable gloves, disposable hats, caps
阳性对照室D级 Positive control chamber class D	蓝色分体服、工作鞋、脚套、一次性口罩、一次性手套、一次性帽子、帽子 Blue split suits, work shoes, foot covers, disposable masks, disposable gloves, disposable hats, caps
整衣灭菌间D级 Whole garment sterilization room class D	粉色分体服、工作鞋、脚套、一次性口罩、一次性手套、一次性帽子、帽子 Pink split suits, work shoes, foot covers, disposable masks, disposable gloves, disposable hats, caps
仓库称量间D级洁净区 Class D clean area in the weighing room of the warehouse	蓝色分体服、工作鞋、脚套、一次性口罩、一次性手套、一次性帽子、帽子 Blue split suits, work shoes, foot covers, disposable masks, disposable gloves, disposable hats, caps
生产上游车间C级洁净区 Class C clean area in the upstream workshop of production	粉色三连体服、工作鞋、脚套、一次性口罩、一次性手套、一次性帽子 Pink trio, work shoes, foot covers, disposable masks, disposable gloves, disposable hats	其中，生产上游车间C级洁净区的手套使用无菌手套： Among them, sterile gloves are used for gloves in the C-level clean area of the upstream production workshop:
生产下游车间粗纯洁净区 Coarse and pure clean area in the downstream workshop of production	海蓝色三连体服、工作鞋、脚套、一次性口罩、一次性手套、一次性帽子 Ocean blue trio, work shoes, foot covers, disposable masks, disposable gloves, disposable hats
生产下游车间精纯洁净区 Pure and clean area in the downstream workshop of production	白色三连体服、工作鞋、脚套、一次性口罩、一次性手套、一次性帽子（右侧以白色三连体服为例，右侧口罩不用） White trio, work shoes, foot covers, disposable masks, disposable gloves, disposable hats (white trione-piece suits are used as an example on the right, masks are not used on the right side)
制剂车间C级洁净区 Class C clean area of the preparation workshop	黄色三连体服、工作鞋、脚套、一次性口罩、一次性手套、一次性帽子 Yellow triaplex, work shoes, foot covers, disposable masks, disposable gloves, disposable hats
QC活性测定室C级、QC微生物限度检查室C级、QC无菌检查室C级、 QC activity measurement room class C, QC microbial limit inspection room class C, QC sterility examination room class C,	白色三连体服、工作鞋、脚套、一次性口罩、一次性手套、一次性帽子 White tri-suit, work shoes, foot covers, disposable masks, disposable gloves, disposable hats
取样间C级 Class C in the sampling room	黄色三连体服、工作鞋、脚套、一次性口罩、一次性手套、一次性帽子 Yellow triaplex, work shoes, foot covers, disposable masks, disposable gloves, disposable hats
制剂车间B级洁净区 Class B clean area of the preparation workshop	白色三连体服、工作鞋、脚套、口罩、一次性手套、一次性帽子、护目镜 White tri-suit, work shoes, foot covers, masks, disposable gloves, disposable hats, goggles
制剂车间B级内衣 Preparation workshop grade B underwear	白色内衣 White underwear
CNC区 CNC Zone	蓝色分体服（圆领）、鞋子、一次性帽子 Blue split suit (crewneck), shoes, disposable hat

5.6.2 粉色分体服样式、蓝色分体服样式与海蓝色分体服样式一致。黄色三连体服、海蓝色三连体服、粉色三连体服（C级）同白色三连体服（B级）一致。一次性物品款式如表内，可不仅限于表内图片。
5.6.2 The style of pink and blue is the same as that of navy blue. The yellow triple, navy blue triple, and pink triplet (Grade C) are the same as the white triplet (Grade B). Single-use items are not limited to the pictures in the table.

5.7 工作服的回收报废
5.7 Recycling and scrapping of work clothes

5.7.1工作服出现以下情况应回收报废。
5.7.1 Work clothes should be recycled and scrapped in the following situations.

工作服发现污损等现象必须报废，如：洁净服袖口、脚口破损、鞋套鞋底变形或被刺破。
Dirty work clothes must be scrapped, such as: clean clothes cuffs, foot cuffs, shoe covers deformed or punctured.

6附件Attachments
6 Attachment Attachments

SMP-MF-029-A01,工作服销毁记录
SMP-MF-029-A01, Overalls Destruction Log

7相关文件Related documents
7. Related documents

无N/A。
No N/A.

8版本历史Version History
8 Version HistoryVersion Story