To convert operations to a digital factory platform, the first
step involves configuration and installation of operator-friendly
OEE tracking and reporting tools with a responsive dashboard
highlighting any problem issues and opportunities. The tool
performs real-time analysis of multiple metrics to provide automated reports to management pinpointing the root causes of any
inefficiencies on the packaging lines.
The digital factory replaces paper and manual log books, informal reporting and inconsistent tracking with digital logs, 24/7
live tracking and advanced analytics.
THE ULTIMATE EFFICIENCY: CONVERT EXPENSE
In one case study, the digital factory model helped a manufacturer reduce labor costs 19% by analyzing performance metrics
with smart technology installed unobtrusively around the facility. Results revealed inefficiencies that were overcome by modifying a combination of shifts, workers and production runs and
optimizing labor costs for equipment cleaning protocols and
In another case, wireless sensors connected to packaging line
equipment at a $1 billion generic and specialty pharma manufacturer eliminated the need for manual tracking of equipment
performance and use. The automation of the tracking function
improves operational efficiency. Information was transmitted
to touchscreens via a Wi-Fi network for immediate review and
analysis. Decisions were made faster. Maintenance issues were
handled sooner. Operational efficiency increased 12% in the initial four-month test period.
Further along the supply chain, efficiencies from procedural
changes at LSPs brought about by serialization can be improved
and overcome with strategic planning and implementation of
remedial solutions to bring productivity metrics to new higher
levels of performance.
VALUE ALONG THE SUPPLY CHAIN
Efficiencies gained by manufacturers and contract packagers with
fully automated DSCSA-compliant packaging lines may be lost
further along the supply chain. Manufacturers must think beyond
their own packaging operations and work in partnership with
their downstream partners to maximize value from the investment in serialization.
An important question for manufacturers to ask logistics services providers concerns how performance metrics are being
maintained and improved after serialization to minimize disruption when orders are received, stored and fulfilled.
Serialized product flows from manufacturers to contract packagers, logistics services providers, wholesalers, distributors and
dispensers. The move to serialization involves additional technical complications at every point due to upgraded technology infrastructure, new hardware, software and equipment.
TECHNOLOGY MEETS EFFICIENCY
In most sound management decisions across any industry, technology upgrades are considered and approved in order to reduce
the labor required to perform the same function. However, pharmaceutical serialization differs from conventional logic.
Some technological advances for DSCSA require commensurate increases in time and labor for the same job function. The order receipt process is one key example of increased time required
to perform the same function in a post-serialization environment
compared with pre-serialization procedures.
Prior to installation of technology and equipment upgrades for
DSCSA compliance, the order receipt process involved one step
utilizing a single closed warehouse management system (WMS).
Data about pharmaceutical drug products was scanned by the
handheld gun at the inbound dock and simultaneously recorded
by the WMS. The item was then officially received by the WMS
into active inventory. This process was practically instantaneous
because a single program managed the entire information stream.
The same order receipt process post-serialization encounters
a more circuitous path until it can be recorded as received. The
route to product receipt involves six steps, resulting in an increase
in task performance time and additional potential failures from
the interaction of multiple software systems.
TECHNOLOGY OVERSHADOWS EFFICIENCTY
In a DSCSA-compliant warehouse, an automated shipping notice (ASN) with information about the delivery is transmitted
from the shipper. The pertinent details are then translated into a
file format that is imported by a separate software program called
an Edgeware system.
At that point, the handheld scanner downloads the information from the Edgeware system. When the item is scanned, the
information is transmitted back to the Edgeware system, which
then notifies the WMS. At the same time, the Edgeware program
alerts a different software program called a Level 4 system. Finally, the Level 4 system, not the WMS, designates the item as
In the post-serialization environment, the Level 4 system acts
as the repository for all serialized data and manages communication between upstream and downstream parties as the product
moves within the pharmaceutical supply chain.
AGGREGATION: FROM THE ROOT ‘AGGRAVATE’
The Edgeware system also manages the business requirement for
a process called aggregation. Aggregation is not a legal requirement of the DSCSA but is necessary to achieve a comprehensive
track and trace solution. Aggregation creates a virtual relationship between each individual item within each uniquely labeled
carton included in every uniquely identifiable pallet.
Here’s how it works. Pre-serialization, products with the same
SKU were considered interchangeable. A typical pallet built from
24 cases of 12 eaches or items in each case registered in the system as 288 units of a single item in 12 cases, totaling two computer entries.
In a post-serialization warehouse, the same pallet is recorded
in the system as 24 uniquely identifiable cases each containing 12
uniquely identifiable items. Instead of two entries the serialized
relationship appears as 300 entries comprised of each individual
unique product identifier (UPI) on every item and carton connected in a single aggregated set. The movement of every item
within each carton and on each pallet is monitored throughout
the journey from manufacturer to dispenser.