In this presentation, Wai Wong of Pharmatech Associates discusses how mobile workstations—one of many types of different smart devices—are key components that are moving the industry to Pharma 4.0. Pharma 4.0 is an Industry 4.0 concept applied to pharmaceutical manufacturing. Pharma 4.0 envisions highly efficient automated processes driven by an integrated manufacturing control strategy (i.e. smart factory and the IoT), where sensors, data, and cloud technologies work together to bring a new era of safety, control, and efficiency to manufacturing facilities. Pharmatech Associates consists of four divisions – Validation, PPD, Compliance, and Regulatory Affairs. These four divisions encompass the entire product development lifecycle. At Pharmatech, a product lifecycle approach to pharmaceutical product development and manufacturing, with the key idea of compliance through science, helps clients to build quality into their products from the start. https://pharmatechassociates.com/

1. Mobile Workstations and Pharma 4.0
Presented by: Wai Wong, Vice President of Validation
November 29, 2018
22320 Foothill Blvd. #330
Hayward, California 94541
Telephone: +1-510-732-0177
wwong@pai-qbd.com

2. Pharmatech Associates
Compliance Through Science® 2

3. Mobile Workstations: Efficiency and
Integration Key to Achieving Pharma 4.0
3Compliance Through Science®
• Mobility for the device, and for the user, means not being restricted to
one locationEfficiency
• Long battery life; not tethered to stationary hardwareFlexibility
• Data right at your fingertipsInformation
• Use the same software throughout the company
• Reduces training to learn and maintain multiple software packages to
one place on the manufacturing floor
Integration
• Greatly simplifies commissioning and validationQualification

4. Pharma 4.0 – How It Works
4Compliance Through Science®

5. Mobile Workstations: Engineering and
Manufacturing Benefits
5Compliance Through Science®
Using common
software platform
affects all aspects
of the business
Standardizes
interface between
MES, automation,
and control
systems
Reduces
complexity of
integration; no
issues with
communication
between different
hardware and
software packages
Significantly
reduces design,
procurement, and
setup efforts
In Pharma 4.0,
mobile
workstations are
smart devices for
flexible operation
and monitoring of
the manufacturing
floor.
This “extended
HMI” enables
monitoring and
operating on the
manufacturing
floor or from a
distance
Technicians,
operators, and
supervisors can
access the smart
devices all at the
same time; all
data is real time
Engineering and Manufacturing Benefits

6. Mobile Workstations: Maintenance/Metrology
and Validation Benefits
6Compliance Through Science®
Using the same hardware and software platform as manufacturing helps collaboration:
Scheduling of maintenance activities between manufacturing runs; reduce
equipment downtime
Provides an interface for operating the equipment that is familiar to Manufacturing
operators and Maintenance mechanics and Metrology technicians
Commissioning and Validation will focus on flexibility
Qualify dedicated network to ensure data is secure and accessible (Part 11)
Systems will be qualified as truly “mobile;” no re-calibration or re-verification is required if
the system is moved from location to location
Part
11
OEE
Real
Time
C&Q
Mobile
Connect

7. Mobile Workstations: Benefits For
Operations and Management
Results in a
manufacturing facility
that provides greater:
• Control
• Efficiency
• Predictability
• Safer work
environment
7Compliance Through Science®
Centralizing
collection and
evaluation of
data from
different
sources
Data assessment with real time analysis,
standard reports, and investigative
analysis
Prevent critical failures
Real time data feeds the
predictive model. Facility
becomes predictive instead of
reactive