ap26 - zhejiang medicine co. improves business-process connectivity with mes solution

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Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. Rockwell Automation TechED 2015 @ROKTechED #ROKTechED PUBLIC INFORMATION AP26 What’s in a Label? Zhejiang Changhai Biological Improves Business Process with MES Solution

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Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. Rockwell Automation TechED 2015 @ROKTechED #ROKTechED

PUBLIC INFORMATION

AP26 – What’s in a Label? Zhejiang Changhai Biological Improves Business Process with MES Solution

Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. Rockwell Automation TechED 2015 @ROKTechED #ROKTechED

Agenda

Why Rockwell Automation

Our implementation of label

What’s In A Label

Label Requirements

Who Are We?

Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. Rockwell Automation TechED 2015 @ROKTechED #ROKTechED

1.4H

4.8H

Changhai

Biological Co.

Xinchang

Pharmaceutical

Factory

Vitamin Factory

Bio-Pharmaceutical

R&D Center

Laiyi Pharmaceuticals

Co.

Zhejiang Health

Creation

Shengzhou

.Xinchang

.

Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. Rockwell Automation TechED 2015 @ROKTechED #ROKTechED

Who Are We?

1954 1997

1999

2012

2001

2003 2011

1954: Xinchang Pharmaceutical Factory

1997: Zhejiang Medicine Co., Ltd.

1999: Listed in Shanghai Stock market

2001: Vitamin Factory

2003: Health Creation Biotechnology

2011: Changhai Biological Company

2012: Zhejiang Laiyi Medicine Co., Ltd.

Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. Rockwell Automation TechED 2015 @ROKTechED #ROKTechED

Anti-Infectives

Anti-Viral

Anti-Fungal

Vitamins & Nutritional supplements

Anti-Diabetics

5

Product Categories

Who Are We?

Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. Rockwell Automation TechED 2015 @ROKTechED #ROKTechED

Who Are We?

Our Customers:

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Master Planned,

Developed in stages

Registered :

In March, 2011

Site Area:

85.33 hectares

Nutriceuticals,

API and FDF

Employees:

Over 1, 500 Vision: Global supplier of

nutriceuticals, API and FDF products

Changhai Biological Co. Wholly-owned subsidiary of ZMC

Who Are We?

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Injection Facilities

Who Are We?

Large-Volume

Parental

Small-Volume Parental

OSD

Warehouse

SC

Powder

Injection

Powder

Injection

Ceph/Pen

Onco

Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. Rockwell Automation TechED 2015 @ROKTechED #ROKTechED

Label Requirements

9

WHAT

WHO

TIME

BATCH CODE

……

Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. Rockwell Automation TechED 2015 @ROKTechED #ROKTechED

Label Requirements

10

But the need to carry the information forward! Not the need for physical label,

Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. Rockwell Automation TechED 2015 @ROKTechED #ROKTechED

LABEL

Equip

status

Weighing

Calibration Equipment

identification

Container

identification

Other types

Material

status

Different Types of Labels/ Identification in Pharmaceutical Industry

Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. Rockwell Automation TechED 2015 @ROKTechED #ROKTechED

Hand written, pre-printed, and MES, WMS, LIMS

printed.

Physically attached to equipment or Batch Record.

When techology was not available, hand written was

the simplest, require no capital investment and no IT

involvement.

Then came physical printing when you have some

investment and IT.

12

Status Quo

What’s In A Label?

Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. Rockwell Automation TechED 2015 @ROKTechED #ROKTechED 13

Easily damaged thus rendering the label

unreadable

Once used the label can be hard to remove

Risk of falling off, especially when wet

Laborious to apply and remove

Risk of mixing and rendering usage of wrong

materials/ equipment

Problems with the label:

What’s In A Label?

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Process flow Chart

Sterile fitration

Aseptic Spray Dryer

Sterle powder transfer

Sterile powder filling

Vials

Inspection&labeling

Primary& Secondary pakage

3rd floor

2nd floor

1st floor

LABEL

PACK Warehouse

Our Implementation

Roof

Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. Rockwell Automation TechED 2015 @ROKTechED #ROKTechED

Raw Material

API H2O2

Excipients NaOH

Filter element WFI

Culture Dish …

Packaging

Vial Inter Box

Cap Master Carton

Stopper Instruction

IP/ Finished Product

IP-A Sterilized powder

IP-B FP

Sterilized liquid …

How many labels we need in the process

Raw Material

Packaging

IP/ Finished

Product

Our Implementation

Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. Rockwell Automation TechED 2015 @ROKTechED #ROKTechED

Material

Barcode Sub-Batch No.

Material ID Expiry date

Material name Operator

Batch No. Date/Time

Equipment

Barcode Specification

ID Production date

Material name Sequence No.

Material ID Operator

Batch No. Date/Time

Spareparts

Barcode Status Expiry Date

ID Operator

Quantity Sequence No.

Batch No. ……

Which information need to be included in label?

Material

Equipment

Spareparts

Others

Our Implementation

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Idea implemented on our site

Permanent Marking

Print

Written No hand written label.

MES/WMS printed label

for raw material or QC sample. Unique identifier to digitize all

label. Barcode engraved into the

surface of equipment, material pipe

or other components.

Our Implementation

Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. Rockwell Automation TechED 2015 @ROKTechED #ROKTechED

Network Cable

Desired Operation

Material Label

Identify Material

Standard Operation

Our Implementation

Camera

Mobile Device

WIFI

Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. Rockwell Automation TechED 2015 @ROKTechED #ROKTechED

Why Rockwell Automation?

Mature Pharma MES

platform

Professional Local

Engineering Resourse

Abundant Pharma

Experience and Practice

High Performance-Price

Ratio MES TEAM

Team

Pharma SuiteTM

Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. Rockwell Automation TechED 2015 @ROKTechED #ROKTechED

Vision

报表

平台

事业部MES

报表平台

数据库服务器

昌海生物

1208车间MES

1208车间MES

产区ERP

事业部追溯平台

3068车间MES

操作终端

WEB服务器

数据库服务器

应用服务器接口服务器

3038车间MES

操作终端

WEB服务器

数据库服务器

应用服务器接口服务器

1108 MES

1208 MES

3068 MES 3038 MES

CHBIO

Strategy Co-Operation with Rockwell

Automation

cGMP Compliance Digital Factory

Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. Rockwell Automation TechED 2015 @ROKTechED #ROKTechED

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PUBLIC INFORMATION

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