制造执行系统（MES）在制药行业的应用研究

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摘要

当今国内制药行业现场自动化设备智能程度得到了显著提高，但是生产管理

水平不足，依然采用传统的生产管理方式，与国外先进水平有较大差距。在制造

业向着敏捷生产、即时生产的方向发展的过程中，应用制造执行系统（MES）是

大势所趋。

本文以制药行业的企业信息集成为研究背景，首先分析制造业产业局势，提

出 MES 的概念，分析了 MES 的发展历史及研究现状，然后经过深入研究制药行业

的特点、生产工艺、流程特征等，指出制药行业的环境中传统生产管理的弊端，

以及与现代化生产脱节的部分，提出了应用以 MES 为代表的企业信息系统解决方

案，以提高生产效率和管理效率，具有现实意义。

然后本文结合 S95、S88 标准，MESA 定义等，研究探讨 MES 的系统框架，并

对其中的功能模块进行了详尽的描述与讨论，这是本文研究的一大重点。然后通

过对企业网络结构拓扑的分析，研究 MES 网络框架，并对其实现的关键技术进行

了深入的分析与探讨，这也是本文研究的重点。最后结合实际 MES 软件产品的详

细实例操作阐述了 MES 的具体实施与应用过程，证实了制药行业应用 MES 系统的

可行性，MES 可以实现生产管理实时、高效、可视化的应用效果，相比传统生产

管理模式也具有有很大的优越性。

本文的研究工作和成果在于：

1、研究了 MES 的概念、发展过程和功能模型，深入分析了制药行业的行业

特征、流程特征等，阐述了传统生产管理遇到的问题，如信息孤岛、产品追溯困

难、生产审批费时费力等，以提出 MES 解决方案，针对传统生产管理的环节，阐

述如何通过信息化网络化的途径解决；

2、阐述了基于 S95、S88 标准制药企业应用的 MES 的管理模型，详细阐述了

其几大功能模块；详细研究了企业信息化网络，阐述了 MES 网络结构及应用的关

键技术，具有实际研究价值。

3、借助 MES 产品 Pharma Suite 软件的实施和应用，详细展示了实例生产活

动的执行操作与一般步骤，证实了 MES 的可行性以及与传统人工管理的优越性，

对于实际企业实施 MES 项目具有一定的参考与研究价值。

关键词：制造执行系统制药行业企业信息系统综合自动化

ABSTRACT

Today, the intelligent degree of automation equipments of China’s

pharmaceutical industry field has increased significantly. But the production

management level is low. China’s pharmaceutical industry still adopts the traditional

way of production management, which has a big gap with foreign advanced level.

Manufacturing industry is developing in the direction of the agile production,

just-in-time production. So the application of manufacturing execution system (MES)

is a trend.

Based on enterprise information integration of the pharmaceutical industry, this

paper firstly analyzes the situation of manufacturing industry, then puts forward the

concept of MES. Afterwards, the development history and research status of MES is

analyzed. And then through the in-depth study of the characteristics ,production

technology, process,etc. of the pharmaceutical industry, pointing out the disadvantages

of traditional production management of the pharmaceutical industry and the

differences with modern production. This paper puts forward the application of

enterprise information system represented by MES, in order to improve the

efficiency of production and management, which is practically significant.

Concerning with the S95, S88 standards, MESA definition, this paper studies

system framework of the MES in depth, and discusses the functional modules in the

detailed description. This is a key point in the research of this paper. And then through

the analysis of the structure of enterprise network topology, the MES network

framework is introduced. And the key technology has been thoroughly analyzed and

discussed. This is also a key point in the study of this paper. Finally based on the

actual MES software products, this paper describes the operation of detailed examples

to introduce the specific implementation and application process of MES, which prove

the feasibility of the pharmaceutical industry MES system. MES can realize real-time,

visual and efficient production management. It also has a lot of advantages compared

with the traditional production management.

Research work and achievements of this paper go as follows:

1. This paper studies the concept, development process and the function model of

MES. And the paper in-depth analyzes of the process characteristics of the

pharmaceutical industry. This paper describes the problems of the traditional

production management, such as information isolation, difficult product trace , and

difficult steps of production examination and approval. So, MES solution is put

forward, comparing with the traditional production management, introducing how to

apply the information network.

2. This paper introduces the S95, S88 standards based modules of MES in detail;The

enterprise information network is alos studied in detail as well as the MES network

structure and application of key technologies, which has practical research value.

3. With implementation and application of the MES software--Pharma Suite, this

paper introduces in detail the instance operations of production activities and general

steps of the production activities, proving the feasibility of MES and the priority to the

traditional manual management. This paper has research value and has a certain

reference for actual enterprise implementation of MES project.

Key Word: Manufacturing Execution System, Pharmaceutical

Industry, Enterprise Information System, Integrated Automation

中文摘要

ABSTRACT

第一章绪论............................................................................................................1

1.1 研究背景和意义............................................................................................2

1.2 MES 概述.........................................................................................................2

1.2.1 MES 定义 ...............................................................................................3

1.2.2 Mes 发展历程与研究现状.....................................................................4

1.2.3 制药行业 mes 产生................................................................................6

1.3 研究任务及本文结构....................................................................................6

第二章制药行业业务分析......................................................................................8

2.1 制药行业特征................................................................................................8

2.2 流程特征........................................................................................................8

2.3 制药 mes 产生..............................................................................................11

2.3.1 医药行业管理难点..............................................................................11

2.3.2 应用 MES 带来的效益..........................................................................11

2.4 标准与术语解读..........................................................................................12

2.4.1 GMP........................................................................................................12

2.4.2 GAMP 计算机系统验证.........................................................................12

2.4.3 FDA 验证...............................................................................................12

2.4.4 生产订单..............................................................................................12

2.4.5 BOM........................................................................................................13

2.5 本章小结......................................................................................................13

第三章制药行业 MES 功能框架............................................................................14

3.1 ISA95 模型...................................................................................................14

3.1.1 ISA95 概念...........................................................................................14

3.1.2 S95 中的信息流..................................................................................14

3.1.3 S95 对象模型......................................................................................15

3.2 S88 模型.......................................................................................................15

3.2.1 S88 定义...............................................................................................15

3.2.2 S88 模型...............................................................................................15

3.3 MESA 模型.....................................................................................................16

3.4 MES 实际应用模型.......................................................................................18

3.4.1 物料管理..............................................................................................19

3.4.2 工艺管理..............................................................................................19

3.4.3 生产执行..............................................................................................19

3.4.4 质量管理..............................................................................................19

3.4.5 审核验证..............................................................................................20

3.4.6 资源管理..............................................................................................20

3.5 本章总结......................................................................................................20

第四章制药行业 MES 功能实现............................................................................21

4.1 物料管理......................................................................................................21

4.2 工艺管理......................................................................................................22

4.3 生产执行......................................................................................................24

4.4 质量管理......................................................................................................25

4.5 审核验证......................................................................................................27

4.6 资源管理......................................................................................................28

4.7 本章总结......................................................................................................30

第五章制药行业 MES 网络与通讯技术................................................................31

5.1 网络结构拓扑图..........................................................................................31

5.1.1 制药企业信息化网络结构拓扑图.......................................................31

5.1.2 MES 应用网络结构...............................................................................32

5.2 基于 DDE/OPC 的数据采集技术..................................................................33

5.2.1 DDE........................................................................................................33

5.2.2 OLE 与 COM............................................................................................33

5.2.3 DCOM、CORBA 与 SOAP..........................................................................34

5.2.4 OPC........................................................................................................35

5.3 基于 RTDB/RDBM 的数据库存储技术..........................................................36

5.4 基于 N-tier 的软件系统体系结构............................................................37

5.4.1 1-tier 单层架构.................................................................................37

5.4.2 2-tier 两层架构.................................................................................38

5.4.3 3-tier 三层架构.................................................................................38

5.4.4 N-tier 多层架构.................................................................................39

5.5 本章小结......................................................................................................40

第六章制药行业 MES 软件实施与应用................................................................41

6.1 MES 软件模块介绍.......................................................................................41

6.2 生产执行客户端..........................................................................................41

6.2.1 称量配料..............................................................................................41

6.2.2 物料混合..............................................................................................42

6.2.3 压片......................................................................................................46

6.3 生产管理客户端..........................................................................................47

6.3.1 管理订单..............................................................................................47

6.3.2 管理物料..............................................................................................48

6.3.3 管理工作中心......................................................................................49

6.3.4 管理设备..............................................................................................49

6.3.5 管理仓库..............................................................................................50

6.4 数据管理客户端........................................................................................51

6.5 配方流程设计客户端................................................................................53

6.6 PRC 生产响应客户端.................................................................................55

6.7 本章总结....................................................................................................56

第七章结论与展望................................................................................................57

7.1 全文总结....................................................................................................57

7.2 未来展望....................................................................................................57

参考文献..............................................................................................................59

在读期间公开发表的论文和承担科研项目及取得成果..................................62

致谢......................................................................................................................63

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摘要：

摘要当今国内制药行业现场自动化设备智能程度得到了显著提高，但是生产管理水平不足，依然采用传统的生产管理方式，与国外先进水平有较大差距。在制造业向着敏捷生产、即时生产的方向发展的过程中，应用制造执行系统（MES）是大势所趋。本文以制药行业的企业信息集成为研究背景，首先分析制造业产业局势，提出MES的概念，分析了MES的发展历史及研究现状，然后经过深入研究制药行业的特点、生产工艺、流程特征等，指出制药行业的环境中传统生产管理的弊端，以及与现代化生产脱节的部分，提出了应用以MES为代表的企业信息系统解决方案，以提高生产效率和管理效率，具有现实意义。然后本文结合S95、S88标准，MESA定义等，研究...

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