Engineers at Pfizer's Grange Castle facility have applied generic phases through shorter and simpler code configuration,除了简化调试和更好地利用工艺调试工程师外,writes Conor Boyle

辉瑞生物制药厂自动化工程师格兰奇城堡在都柏林,他们在安多佛的姐妹机构为同事们创建了一个一刀切的通用就地清洗(CIP)阶段类。马萨诸塞州。The new phase class has the potential to slash current software development times for CIP by up to 80% and to eliminate delays due to automation rework at the commissioning stage.

Pfizer combines state-of-the-art research and development (R&D) facilities with flexible,multi-product manufacturing capabilities at its 70-acre site in Andover.该设施在战略上定位为一个完全集成的场地,serving as a vital cog in both Pfizer's R&D and Pfizer Global Supply network.

为了简化站点之间的产品传输,辉瑞全球工程公司决定将其位于安多佛现场的传统可编程逻辑控制器(PLC)系统升级为艾默生·德尔塔夫(Emerson Deltav)分布式控制系统(DCS)。与格兰奇城堡设施相匹配。

在这一决定之后,automation engineers in Andover called on their colleagues in Grange Castle to assist with software development for the upgraded control system.As the Grange Castle control system was built on the Emerson DeltaV platform (an Emerson Digital DCS) 15 years previous,爱尔兰工厂的自动化工程师有丰富的经验,他们的美国同事希望利用这些经验。



最初在Deltav平台上协助开发了一套设备模块(EM)类,Grange Castle团队被要求解决开发CIP阶段类以清洁所有设备的问题(S88批次控制结构中设备模块和阶段的位置见图1)。

The Andover facility had the full range of equipment one would expect to find in a state-of-the-art biopharma facility,from buffer vessels to bioreactors of various sizes,media vessels,chromatography feed and pool vessels,various depth filtration and virus filtration skids,and a myriad of transfer lines inter-connecting all of this equipment – all cleaned with the help of 600+ phase-logic-modules running on the existing PLC system.

以传统的方式来取代它,每单位类别一个相位,或按需清洁的用户,可能会导致许多CIP阶段类。这将保守地花费一小队自动化工程师数万小时来开发各个功能规范,then code and test the resulting software on a development system.

Faced with this task,the automation team at Grange Castle decided to look at the possibility of creating a single,通用CIP阶段类,可用于清除大量不同的CIP用户。


  • Liquid cycles such as acid and base 188betsportchemical wash cycles,reverse osmosis water/ non-potable cold water (ROW/NPCW) cycles and water-for-injection (WFI) rinse cycles;;
  • Dry cycles such as air blow and drain;;
  • 代码驱动CIP撬块(CIP供应泵以及清洗和冲洗罐所在地)以规定的流速进行化学清洗和注射用水清洗等各种命令和设定点;188betsport;
  • Equipment module commands and sequencing needed to open and close the user loops to be cleaned in the required order and in a manner that prevents dead-heading the CIP supply pump;;
  • 各种计时器:用于测量通过每个循环的流的持续时间的循环计时器,switch timers when switching between loops,and flow stabilisation timers prior to the commencement of pulsing on wash cycles;;
  • 回路选项,如局部导电探针,用于测量返回到局部排水口而不是CIP撬块主排水口的回路的最终冲洗导电率。

Detailed analysis of the liquid and dry cycles revealed significant amounts of very similar code,which were ultimately some variation of:

  • 驱动设备模块按设定顺序命令打开下一个回路/关闭上一个回路;;
  • 将CIP撬块驱动至所需的命令和流量设定点,等待流量稳定,commence pulsing and start loop timer and monitor flow for the duration of the timer,当条件满足且计时器过期时,移动到下一个循环并重复。

Grange Castle的团队希望设计一个满足上述所有要求的阶段性课程,但当涉及到设备特定数据时,允许最大的灵活性,并且可以跨单元级工艺设备进行移植。

Solution: better separation of generic CIP process tasks

The result of the team's efforts is a two-part solution:

  • 一个通用的CIP相类,包含每个CIP循环的复合物(空气吹扫,rinse,188betsport化学清洗,etc),每一个都有所有需要的步骤,比如开环,闭环和循环定时器。However,all of the data that the steps require to execute – such as EM commands,EM命令,回路流量,循环持续时间等——抽象为CIP数据功能模块(FM——无任何输入/输出的控制模块);;
  • CIP数据FM(以及随附的详细面板)它充当所有用户可配置和循环排序数据的存储库。The data FM stores data such as the collection of CIP cycles which go together to form the cleaning regime,单个循环名称,equipment module names and durations for each loop to be cleaned.The FM stores the enormous amount of EM-related data (command,秩序,路径,脉冲数据)。This facilitates the storage of up to 90,以高效的方式处理1000条数据。


The fundamentals of the design for this phase were a further development of the existing in-house Pfizer software library,which was initially created for the active pharmaceutical ingredient industry,and was then broadened to suit the rapidly expanding biotech sector.


Built-in flexibility

The phase class is designed to be flexible.The cycles can be run in any preconfigured order,as can the loops.每个步骤包含驱动多达20个EMS的代码;然而,仅驱动那些为运行循环/循环配置了命令的EMS。同样地,if a switch timer setpoint for a cycle is left blank,the timer step is skipped.


For speed of operation at runtime,phase类在首次加载时从CIP数据FM复制所有数据。This avoids delays in reading from a separate module when loop cleaning is in progress and time is at a premium.

One CIP data FM is required for each CIP circuit and has enough storage to cater for various CIP types e.g.完整和缩写(缩写的CIP通常是没有任何化学清洗循环的CIP)。188betsport



阶段类的开发是为了最大化可移植性,在引用用户设备模块时完全避免使用别名(别名是单元类的参数,然后在单元级解析为相关的em)。It is generally this list of aliases which ties a phase class to a particular unit class and hinders portability,因为不是每个容器都有搅拌器,例如,一个ph-em。





To simplify interpretation of the parameter values in the CIP data FM,the Grange Castle team created several detail faceplates that contextualise the data into a readily understandable format.These allow the user to see the data in a pseudo-English format,不是一堆乱七八糟的数字,thus enabling them to interpret what goes on at the equipment level on a loop-by-loop basis.

The main detail faceplate (Figure 4) allows for viewing and configuring equipment setup such as cycles,loop names etc as well as loop durations and CIP system options,while the equipment module sequence detail faceplate (Figure 5) allows for viewing and configuring the EM commands and sequences that the equipment will execute to open and close each loop as the CIP cycles are performed.

Generic model slashes development time

这种方法减少了自动化工程师的软件开发和测试时间,and empowers process commissioning engineers on the production floor.According to the team at Grange Castle,this approach slashes development time by up to 80%.

Using the traditional approach for a new vessel or line CIP phase class,根据复杂性,200-300小时的估计是典型的。这个估计允许以下:

  1. Gathering of process requirements,which might include a set of piping and instrumentation diagrams (P&IDs) with highlighted cycles/loops;;
  2. Development of an individual functional specification – hand crafted to the specifics of the new circuit;;
  3. 在测试系统上开发相级代码;;
  4. Development of an individual test specification for a software factory acceptance test (FAT);和
  5. Software FAT execution.

在通用CIP阶段类的情况下,步骤1仍然存在,正如人们所期望的,但是步骤2,3,4和5被删除,因为代码是固定的,并且之前对所有场景进行了测试。These steps are instead replaced with a parameter configuration step for the CIP data FM.

这是将突出显示的P&ID中的信息转换为一系列循环和路径以输入CIP数据FM的相对简单的练习,以及循环持续时间和开关计时器等,an exercise which is carried out either via the detail faceplates or via the customised Excel configuration tool.This simplified process is conservatively anticipated to require no more than 40 hours to configure a CIP data FM for a new circuit.

In addition to simplifying the task of CIP configuration,the detail faceplates also minimise the possibility of configuration errors.当执行配置的工程师选择要在其上指定命令的em时,an intelligent script in the faceplate first interrogates the EM to read the list of available commands and presents them in a drop-down list on a pop-up,从而确保不能指定无效的命令。

Similar scripts in the detail faceplates also prevent the selection of sub-loop paths in loops for which sub-loops have not been configured or the addition of a local conductivity probe which does not match the name of a probe in the configuration database.

These scripts help prevent a myriad of errors which would otherwise not get caught until testing were the code configured directly via DeltaV Control Studio (Emerson's DCS coding application).


Not alone do the detail faceplates ease configuration by giving access to all of the equipment and sequencing data,它们也允许在运行时进行更改——授权参与调试的过程工程师。

使用传统的方法,其中相位类是硬编码的,if a loop fails to open because of an incorrect configuration,调试通常会逐渐停止,需要自动化工程师的协助。然后,自动化工程师必须启动一个变更控制过程:记录需求,seek approval signatures,modify and test the software and then download the tested code before the process commissioning engineer can rerun the CIP.

This process can be time consuming,失去宝贵的调试时间,或者可能失去生产计划中的一个时间段。Now,instead the process commissioning engineer simply modifies the configuration,通过细节面板,to correct the valve sequencing,or modify the parameter value that caused the disruption and restarts the CIP.这个过程只需要几分钟而不是几小时,or indeed days,required for a standard change control process.

On completion of commissioning,the modified CIP configuration can be uploaded to the offline database and exported to capture the modifications made during commissioning.

Grange Castle的自动化工程师也创建了一个配置工具,using Visual Basic to create an Add-In for MS Excel,which allows the CIP data FMs to be created in an offline environment on a standard PC without any special licensing.该工具还方便将CIP数据FMS导入和导出到Deltav数据库,并以Excel工作表的形式创建软件设计规范文档。

The future is bright,the future is generic

Given the potential savings to projects – through shorter and simpler code configuration,除了简化调试和更好地利用工艺调试工程师之外,Grange Castle的团队还看到了通用阶段应用的光明前景。

CIP通用方法的原则同样适用于希望减少传统定制CIP过程和自动化工程活动固有的调试开销的任何设施,and move towards a leaner,更多流程驱动,approach.

Having delivered a generic CIP solution,the automation team are currently working on the development of a combined generic pressure test and steam-in-place solution,带有补充数据FM和详细面板。They anticipate that this will deliver similar benefits for their US colleagues,and indeed future Irish use cases,在灵活性和节省时间方面。


Conor Boyle

康纳·博伊尔·曾,MIEI is an automation engineer for Rockwell Automation with over 15 years' experience in biopharma and is embedded at Pfizer,Grange Castle as a subject-matter-expert in Delta-V

Amod Gokhale,自动化工程师,辉瑞庄园城堡
Sergiu Pasca自动化工程师,辉瑞庄园城堡
James Galloway工艺工程师,辉瑞全球工程
Iain Logie,MES顾问,艾默生过程管理

Automation engineers at Pfizer's biopharma facility at Grange Castle in Dublin have created a one-size-fits-all generic clean-in-place (CIP) phase class for their colleagues at their sister facility in Andover,马萨诸塞州。新的阶段类可以将当前CIP的软件开发时间缩短80%。