PO Q1 2021 - 34

CONTRACT MANUFACTURING

A Digital Shift in Communications
Helps Pharmaceutical Manufacturers
Operate at Pandemic Speed
Andreas Eschbach
CEO
eschbach
www.shiftconnector.com

Second Shift Perspective: Manufacturing
Cleanroom Automation Operators

As biopharma companies race to develop drugs and vaccines at
" pandemic speed, " quality control strategies and shift-to-shift
communications must keep pace. It is all about managing people,

Pharmaceutical production has been faced with a task of changing
operations to facilitate production of products related to the
pandemic. The industry has been in constant transition from
producing block-buster medicines towards personalized medicine
to break-through vaccines, which for production teams, means there
will be increasing variations in the production processes. Agility and
flexibility are paramount during these trying times.

processes, and technology. With the increasing number and
complexity of drug products - including biologics, sterile injectables,
cell therapies and vaccines, it has become evident that pharmaceutical
and biotech companies are experiencing extraordinary challenges
arising from disruption in supply chains and the need to change
business processes to accommodate social distancing, remote
working, and quarantining.

For instance, one biopharma company originally focused on
automating microbial quality control quickly expanded after
COVID-19 to deliver contaminant testing for pharmaceutical and
vaccine manufacturing. And like many pharmaceutical companies,
the need for digitizing shift management became more dire as this
pandemic ignited the need to shorten the supply chain for critical
drugs and vaccines while enabling biopharmaceutical companies to
operate their manufacturing facilities with reduced staff.

In these unparalleled times, pharmaceutical companies are finding it is
critical to invest in stronger communications and more collaboration
amongst their production teams, which are often dispersed and
working around the clock in shifts. Drug development processes from
lab to launch have always relied on their teams to communicate face
to face (F2F). This is especially true for pharmaceutical manufacturing
operating continuously. In fact, with the impending need for large-

In this example of a pharmaceutical manufacturer focused on
microbial quality control and contaminant testing, the second-shift
manufacturing cleanroom automation operators needed better
communications with its third shift to ensure safe operations of its
automation lines to target overall equipment effectiveness (OEE)
conditions and deliver a quality product to customers. Any silo of
communication among shifts could mean a decrease in quality
in the production of cell culture cassettes and the potential loss
of customers.

scale vaccine production, many pharmaceutical companies must
equip themselves with the right tools and systems to automate and
instantly capture vital communications and key information during
shift handovers.
Prior to COVID-19, regulatory requirements were key contributing
factors supporting the automation of data capture between shifts. In
addition, the myriad of systems like Manufacturing Execution Systems
(MES), Quality Management Systems (QMS) and Enterprise Resource
Planning (ERP) systems are integrated to deliver key information to

Cleanroom operators conduct manufacturing in a cleanroom
environment (ISO 8) and carry out line cleaning, machine/process
set up, web line set up and basic maintenance tasks related to the
automation line. It's vital that all manufacturing shifts communicate

personnel on the manufacturing lines. These systems can relay vital
information about production performance or quality that quite often
would normally require human intervention or acknowledgement.
Pharmaceutical Outsourcing |

34

| January/February/March 2021



http://www.shiftconnector.com

PO Q1 2021

Table of Contents for the Digital Edition of PO Q1 2021

PO Q1 2021 - Cover1
PO Q1 2021 - Cover2
PO Q1 2021 - 1
PO Q1 2021 - 2
PO Q1 2021 - 3
PO Q1 2021 - 4
PO Q1 2021 - 5
PO Q1 2021 - 6
PO Q1 2021 - 7
PO Q1 2021 - 8
PO Q1 2021 - 9
PO Q1 2021 - 10
PO Q1 2021 - 11
PO Q1 2021 - 12
PO Q1 2021 - 13
PO Q1 2021 - 14
PO Q1 2021 - 15
PO Q1 2021 - 16
PO Q1 2021 - 17
PO Q1 2021 - 18
PO Q1 2021 - 19
PO Q1 2021 - 20
PO Q1 2021 - 21
PO Q1 2021 - 22
PO Q1 2021 - 23
PO Q1 2021 - 24
PO Q1 2021 - 25
PO Q1 2021 - 26
PO Q1 2021 - 27
PO Q1 2021 - 28
PO Q1 2021 - 29
PO Q1 2021 - 30
PO Q1 2021 - 31
PO Q1 2021 - 32
PO Q1 2021 - 33
PO Q1 2021 - 34
PO Q1 2021 - 35
PO Q1 2021 - 36
PO Q1 2021 - 37
PO Q1 2021 - 38
PO Q1 2021 - 39
PO Q1 2021 - 40
PO Q1 2021 - 41
PO Q1 2021 - 42
PO Q1 2021 - 43
PO Q1 2021 - 44
PO Q1 2021 - 45
PO Q1 2021 - 46
PO Q1 2021 - 47
PO Q1 2021 - 48
PO Q1 2021 - Cover3
PO Q1 2021 - Cover4
https://www.nxtbookmedia.com