2020 PACKAGING TRENDS - Pharmaceutical Manufacturing · 2020. 10. 6. · potential glass shortage,...

2020

PACKAGING TRENDS

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TABLE OF CONTENTSUnder pressure 3

Can the glass packaging industry withstand the weight of COVID-19?

Let’s not do this again: Aggregate early 13

Whether or not enforcement begins in 2023 there are ample reasons to start aggregating

ahead of the deadline

Improving supply chains in crisis 19

Best practices for modern label management

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eBOOK: Packaging 2020 2

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It was all smiles at the White House in

2017 when executives from Corning

Incorporated visited President Trump’s

administration to unveil an innovative new

pharmaceutical vial. As part of the White

House’s “Made in America” initiative, Corn-

ing brought a sample of its Valor Glass

container, which was developed with Pfizer

and Merck, and had become the first new

pharma glass composition approved by the

U.S. Food and Drug Administration in over

100 years.

To demonstrate Valor Glass’ durability —

one of its prime advantages over traditional

borosilicate glass — Corning’s CEO, Wendell

Weeks, asked the president to break a con-

ventional vial by pressing down on it with a

lever. In one quick pop, the borosilicate vial

was shattered.

“I’m pretty strong,” the president quipped

with a smile.

“You ain’t seen strong yet, brother,” Weeks

responded to a room full of laughter.

When Trump pushed his weight onto the

lever pressing down on the Valor Glass, the

vial didn’t budge.

At the time, it was touted as another exam-

ple of ingenuity by an American company.

Now, a few years later, glass vials — includ-

ing Valor Glass — have become a critical

linchpin in the White House’s efforts to

bring an end to the coronavirus outbreak.

And the strength, not just of vials, but

of the pharmaceutical glass industry as

a whole, will be a determining factor in

whether or not America — and the rest of

Under pressureCan the glass packaging industry withstand the weight of COVID-19?

By Meagan Parrish, Senior Editor



the world — can finally bounce back from

the pandemic.

In fact, it wasn’t long after drug developers

kicked off their mad dash to create a vac-

cine earlier this year that the world wised

up to the additional concern of having

enough vials. For the past few months,

headlines have blared that there may be a

vial shortage coming and the worries have

thrust packaging — part of the pharma

industry that’s normally behind the scenes

— into the public’s glare.

Meanwhile, the glass packaging market

has launched into a fervent sprint of its

own to ensure that when a vaccine is

approved, pharma companies will have a

way to deliver it to patients. Like pharma

companies developing a vaccine, the U.S.

government has also been helping the

packaging industry along, pumping millions

of dollars into the efforts to quickly ramp up

capacity for glass vials.

But as the industry races to produce the

needed vials for SARS-CoV-2 vaccines, small-

and mid-sized pharma companies looking to

package other therapies could be left behind.

While some glass companies are optimistic

that they will be able to meet the demand

being generated by the coronavirus while

keeping up with existing commitments,

others admit that the market for glass vials

could be in shortage for many months

to come.

How can the glass industry keep its supply

lines from cracking under the weight of

COVID-19?

GLASS OR NO GLASS?There’s a kind of confidence your company

can emit only when it’s successfully been

in business for over a century. In the tight-

knit community of glass vial producers, that

self-assuredness is well on display.

“Schott is one of the oldest companies in

pharma history and is working closely with

the top pharma companies globally,” Stefan

Marc Schmidt, vice president of global sales

and marketing at Schott AG says. “Right

from the start of this COVID crisis, we

have been in close contact with custom-

ers and have been working on scenarios

and different ways to be prepared. That’s

what we do.”

Stevanato Group estimates that global demand for vials will rise by 1-2 billion over the next two years.



When asked about whether or not Schott

— one of the industry’s leading glass man-

ufacturers— would be able to produce

enough vials to meet the surging demand

for a coronavirus vaccine, Fabian Stöcker,

Schotts’ vice president of strategy and

innovation, echoed Schmidt’s sentiment

that the company is poised and ready.

“We have been surprised that this is an

issue in the press,” Stöcker says.

The combined experience of the top titans

in glass manufacturing should make the

industry well suited to the task of meeting

the unprecedented packaging demands for

a SARS-CoV-2 vaccine.

Three companies — Schott, Corning and

Nipro Pharma Corporation — control

the lion’s share of the market for

pharmaceutical glass tubing, which is

the primary component used to make

containers such as vials and syringes. The

top two glass tubing manufacturers have

been in business for over 100 years each,

and difficult barriers to entry, such as the

high complexity and cost of manufacturing

type 1 borosilicate glass (the most common

type of glass on the pharma packaging

market), have kept the tubing industry

small. Underneath the glass behemoths,

there is also a bustling market of converters

— companies who turn glass tubing into

vials or syringes.

“There are hundreds of converters who turn

tubing into vials,” explains Brendan Mosher,

vice president and general manager at

Corning. “So you have a very consolidated

tubing market and then a very fractured

converting industry.”

Despite the combined experience of glass

manufacturers, with so few of them, it

also stands to reason that there could

be concerns about the industry being

nimble enough to handle a sudden surge

in demand. Stevanato Group, an Italian

manufacturer of vials, estimates that global

demand for vials will rise by 1-2 billion over

the next two years. Even before the corona-

virus pandemic, the industry faced worries

that there could be a type 1 borosilicate

glass vial shortage. Part of the problem

is that glass manufacturing facilities are

expensive to build. Then, there can be

challenges with obtaining the needed key

raw material — a particular kind of angular

sand found in riverbeds and beaches that’s

There is a concern that once effective vaccines become available, lead times [for vials] may increase even further. —David Enloe, president and CEO, Aji BioPharma Services



in high demand around the world for a

number of products.

Earlier this year, John Bell, a professor at

University of Oxford (where one of the

leading SARS-CoV-2 vaccine candidates is

being developed) sounded the alarm over a

potential glass shortage, claiming that there

are just 200 million vials left in the world.

But Stöcker waves those concerns away.

Based on Schott’s internal auditing of

the market, Stöcker says that the current

capacity for glass containers for injectable

drugs is 50 billion, including cartridges,

syringes and other containers. Of that 50

billion, Stöcker says that the current global

supply for vials alone is 16-18 billion.

The market was also already on the

upswing. Due to rising demand for vials

from developing countries, Schmidt says

that the glass container market has been

expanding 3-5 percent each year, and

Schott had already planned a $1 billion

investment in building out its existing

capacity for both glass tubing production

and converting.

“For the last few years…there have been

drug shortages in the U.S.,” Stöcker says.

“But that has nothing to do with packaging.”

Mosher, however, describes the market for

glass tubing as “extremely tight.”

“Corning is the second biggest borosilicate

tubing producer behind Schott,” Mosher

says. “We make enough tubing for approx-

imately six billion vials a year. But we have

been in a sold-out condition for the past 18

months.”

THE HUNT FOR GLASSLawrence Ganti, chief business officer at

SiO2, a company that has innovated an

alternative vial to borosilicate glass, agrees

that some pharma companies are having

a hard time securing glass packaging from

the leading suppliers.

“We have been told by many customers

that when they call asking for glass, they

are turned away, or asked to pay ridiculous

upfronts to obtain it,” he says.

Given the challenging market conditions

and the fact that glass manufacturers want

to make sure they have enough supplies

ready to fill orders for a coronavirus vaccine

once one is approved, Ganti says that the

top players in “Big Glass” are prioritizing

who they can make commitments to — and

it’s often only Big Pharma companies.

Currently, Schott says it is not turning down

orders or requests from customers.

“We openly discuss the business case,

negotiate and make a competitive offer to

our customers,” Schmidt says.



But Mosher admits that Corning is some-

times “turning away customers because we

have already committed capacity.”

“Big Pharma companies that already have

contracts in place should be fine,” Mosher

says. “I think for small- to mid-sized com-

panies, it is going to be much more difficult

[to secure vials] if they don’t have existing

supply agreements.”

How can the glass industry juggle the

sudden need for more vials and keep

smaller pharma companies stocked up?

BOROSILICATE ALTERNATIVESWhen SiO2 launched, the goal was to

develop a new pharma container that was

as stable and safer than glass but as dura-

ble as plastic to reduce breakage during

manufacturing. After about 10 years and

$500 million in R&D, the company released

a plastic vial containing a microscopic inner

glass lining that’s 50 times thinner than a

human hair.

“What we’ve managed is to advance a new

material which takes all the durability of

plastic and marries that to all of the stability

properties of glass so that you have none of

the negatives of either but the positives of

both,” Ganti says.

Interest in the SiO2 vials has trickled in from

pharma companies since the product was

commercially released about a year ago —

but many customers were reluctant to to

take the leap.

“People said it was cool tech but they didn’t

want to change because they didn’t want to

be the first,” Ganti says.

Now, since a number of Big Pharma com-

panies have converted to the SiO2 platform

and there’s more focus on supplying vials

for a coronavirus vaccine, Ganti says that

the number of companies looking for an

alternative vial has shot up.

“About 60 to 70 percent [of pharma com-

panies] are coming to us now because of

concerns with glass,” Ganti says. “Before,

the time between meetings with companies

was months — now it’s days.”

Before 2019, Ganti says that there were

seven drug products being tested in clin-

ical trials with SiO2 containers — now

there are 41. Given the sudden interest in

We make enough tubing for approximately six billion vials a year. But we have been in a sold-out condition for the past 18 months.—Brendan Mosher, vice president and general manager, Corning



securing vials, SiO2 has also doubled its

sales forecast for this year, from a 200

percent increase over 2019 to a 400-500

percent jump.

Ganti admits that the SiO2 vials are still a bit

more expensive (about 5-10 percent more)

than traditional borosilicate containers, but

stresses the many benefits, such as elimi-

nating breakage, faster time to market and

increased patient safety. And because the

glass material is made by chemically apply-

ing the inner layer — made from SiO2 and

vapor — by using plasma energy, there are

no raw materials concerns.

Mosher says that Corning is also steering

customers in the direction of Valor Glass if

the company is unable to fulfill a request for

borosilicate containers.

When developing Valor Glass, Corning’s

goal was to eliminate delamination from

vials, which contributes to glass flaking and

subsequent recalls. After conducting a root-

cause analysis, Corning discovered that

boron — a mineral in borosilicate glass —

can become unstable at high temperatures

and contribute to delamination. Eventually

Corning innovated a new composition that

eliminates boron but keeps the glass’ other

needed elements: silica and alumina.

The aluminosilicate formulation in Valor

Glass not only addresses delamination,

it is also more mechanically resistant to

temperature swings and is less prone to

breaks and damage, which improves effi-

ciency and speed on the filling line.

Mosher says Corning is working with

customers every day on adopting Valor

Glass for new drugs, but because of the

investment associated with revalidating

manufacturing lines for new containers, it’s

a tougher sell for existing drugs.

“It’s a no-brainer for new drugs,” Mosher

says. “But there are time and conversion

costs for existing drugs. For that reason, we

are working closely with global regulatory

authorities to streamline the adoption pro-

cess for innovative technologies like Valor

Glass.”

Even with alternative packaging options

on the market, the pharma glass industry

is going to have to ramp up capacity for all

vials if it’s going avoid being pummeled by

rising demand.

A CAPACITY CURE?Just as the Biomedical Advanced Research

and Development Authority (BARDA) has

been injecting the pharma industry will

hundreds of millions of dollars to support

the development of a vaccine, government

agencies have also been throwing money at

the vial problem.

In June, BARDA announced two major

investments to expand vial manufacturing



— one is a $143 million contract with SiO2

to scale its per-month capacity to 10 million

containers (which can hold up to 10 doses

of a vaccine each) by November. Ganti says

the contract will add 200 employees to its

manufacturing site in Alabama. In addition

to supplying Moderna with vials for its vac-

cine candidate, the company is also working

with six other coronavirus vaccine devel-

opers, who are testing their products in

SiO2 containers.

Corning also secured a $204 million grant

from BARDA to increase capacity for its

Valor Glass products at facilities in New

York, New Jersey and North Carolina.

Because Corning has agreed to grant pri-

ority access to drugmakers designated

by BARDA who are developing a vac-

cine, Mosher says the company could sell

out its capacity of Valor Glass to BARDA

through 2021.

The Coalition for Epidemic Preparedness

Innovations (CEPI) has also invested in

securing a supply of vials across the Atlan-

tic. In June, CEPI announced a supply

agreement with Stevanato to procure 100

million containers that will be able to hold

up to 2 billion doses of a vaccine.

Andrea Zambon, marketing and product

management director at Stevanato says

that the company has already secured an

ample supply of glass containers and is

fast-tracking access to four of its converting

lines in Italy and Mexico.

“This preferred access [for CEPI] will remain

in place through the end of 2021, by which

time we will mostly like have a vaccine

approved and distributed worldwide,”

Zambon says.

When asked if the CEPI deal could impact

Stevanato’s ability to keep up with other

commitments, Zambon says “not at all.”

“We’ve proactively increased our capacity

worldwide, and are committed to main-

taining exemplary service to our standing

customer base as well as the approxi-

mately 30 additional programs in which

we’re involved pertaining to COVID-19,”

Zambon explains.

The widespread ramp-up mode of pharma

is also trickling down to purchases for

packaging equipment, according to the

Association for Packaging and Process

Technologies (PMMI).

“As researchers and scientists actively

pursue development of a safe and effec-

tive vaccine for the coronavirus, PMMI’s

June 2020 Purchasing Index indicates that

investments in packaging machinery for the

pharmaceutical and medical device sector

are vastly exceeding figures for other sec-

tors such as food, beverage and personal



care,” says Jorge Izquierdo, vice president,

Market Development, PMMI.

Despite the capacity increases, many com-

panies are preparing for a rocky market in

the short term.

David Enloe, president and CEO, Aji Bio-

Pharma Services, a global integrated drug

product contract manufacturer, says his

company is now experiencing extended

lead times on glass vials that are up to 12

months in some cases — and the situation is

likely to get worse before it gets better.

“There is a concern that once effective

vaccines become available, lead times may

increase even further, despite commitments

from glass manufacturers to increase tubing

and converting capacity. This will be an

added strain on CDMOs and their ability to

meet clients’ timelines for non-COVID-19

products,” Enloe says.

To help mitigate the risks, Enloe says Aji

BioPharma Services is working with its part-

ners to select vials and stoppers that may

be less impacted by the push for a corona-

virus vaccine vial.

“For vaccines it appears that a 10mL vial

and 20mm serum stopper are most popular,

which would provide more than ten doses

per vial. There is also interest in 20mL vials

with a greater number of doses, which may

help cut the vial demand by half,” he says,

adding: “It’s important to remember that

CDMOs, drug innovators and glass suppliers

need to communicate and collaborate now

more than ever to address these supply

chain challenges in order to successfully

address the upcoming COVID-19 vaccine

demand as well as continue to support all of

the other patient needs.”

How long before the market levels out? The

predictions vary.

“In late 2019, it had been predicted that

the supply of glass tubing would stabi-

lize by the end of 2020,” says Kazunori

Ashida, president of Namicos Corporation,

a Japanese manufacturer of ampoule vials.

“However, now due to the sudden increase

in demand for vials in anticipation of a

COVID-19 vaccine rollout, we expect the

shortage to continue. For this reason, even

though ampoule and vial makers are put-

ting forth strong efforts to ramp up their

In June, BARDA announced two major investments to expand vial manufacturing.



production capacity, we anticipate that it

will take several years to stabilize.”

Mosher says that given the fact that all of

the major suppliers have announced capac-

ity expansions, the situation could start to

resolve itself “in the next 12 to 18 months.”

Mosher adds that the increase in capacity

could even eventually lead to an excess in

the supply of vials.

One thing glass manufacturers all agree on

is that — just like drugmakers — the industry

is banding together to make sure there will

be enough supply to effectively distribute a

coronavirus vaccine around the world.

“The industry is putting aside the compet-

itive spirit,” Mosher says. “It feels like more

than ever, that everyone is in this fight

together.”



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We’ve seen this movie before,

and it doesn’t end well.

U.S. pharma companies are

finding themselves in a place eerily remi-

niscent of five years ago. Back then, all of

us were fairly certain that U.S. Food and

Drug Administration would mandate unit-

level serialization at some point…we just

didn’t know exactly what the directive was,

or precisely when it would go into effect.

Although it was evident track and trace

was coming, the pharma sector had seen

enough false starts (remember “California

2015”?) that initial efforts to comply with

Phase 1 of 2013’s Drug Supply Chain Seri-

alization Act (DSCSA) were tepid, to put it

mildly. For a long while, pharma companies

didn’t really buy in and, because of that,

didn’t really buy infrastructure.

It was a recipe for disaster: a series of delays,

directives and clarifications to a law requiring

large-scale equipment investment, person-

nel training and production line disruption.

Amid the confusion, many pharma compa-

nies refrained from commencing the long,

expensive trek to serialization until they were

completely sure what would be required

of them, and when. In hindsight it’s hard

to blame them for needing the inevitable

enforcement extension, delaying potential

penalization until November of 2018.

That said, with mandated aggregation by

2023 a likelihood, can we all agree not to do

this again?

WHERE WE ARE TODAYHere’s where aggregation stands: the FDA

is currently gathering insight from suppliers

Let’s not do this again: Aggregate early Whether or not enforcement begins in 2023 there are ample reasons to start aggregating ahead of the deadline

By Harry Saint-Preux, Vice President, Sales & Operations —Americas; Gaurav Mohite, Product Manager, Track & Tace — ACG Inspection



to precisely define how DSCSA’s next

phase, called “Enhanced Drug Distribution

Security” (EDDS), should work. For the

EDDS phase, the goal is to require all

stakeholders in the pharmaceutical supply

chain to include unit-level serial numbers

with accessible transaction information (TI)

on all prescription drugs. A nod to greater

transparency and accountability, entities

selling prescription drugs will be required

to know precisely when unit-level serial

numbers are included in their shipments.

This will necessitate that the entities have

their own serial number-based packaging

hierarchy — in other words, aggregated data

— which would not need to be provided to

customers but would need to be given to

any third-party logistics providers.

The DSCSA’s EDDS phase is scheduled to

begin in November 2023. And that brings

us back to 2020, circa 2015: a crucial yet

still-nebulous law with enough time remaining

until compliance to trick all of us into thinking

we have more time than we actually do.

Though X factors still remain, sufficient

direction has been given so that pharma

companies can avoid being part of the inev-

itable last-second dash to aggregate. If 2018

was a horror show, why star in the sequel?

Here are just a few reasons why pharma

EXHIBIT 1

Packaging level concept

Government repository

Serialization corporate repository

Serialization site server

Machine controllers

ERP (Enterprise Resource Planning)WMS (Warehouse Management System)

MES (Manufacturing Execution System)

Level 5Government

Level 1Sensing devices

Level 0Production process

Level 4Corporate IT solution

Level 3Plant/Distribution center

Level 2Line controllers & intelligent devices



companies should aggregate now rather

than panic later.

AGGREGATION IS MORE COMPLICATED THAN UNIT-LEVEL SERIALIZATIONExplaining why implementing aggregation

is more complicated than serialization is,

ironically, quite simple: Serialization is ver-

tical whereas aggregation is horizontal. The

former is an effort largely undertaken under

one’s own roof; the latter is an inter-com-

pany operation forged in conjunction with

limitless partners, companies and oversight

entities. As a discipline, aggregation will

tighten operational practices and allow

pharma companies to strengthen quality

assurance checkpoints.

Serialization can be described as a “levels

ladder,” with the first three steps compris-

ing the infrastructure to serialize (vision

systems, printers, etc.) and the orga-

nizational setup necessary to sync up

company-wide traceability initiatives. Level

4 serialization was the “enterprise” step in

which this data could be properly reported.

By contrast, aggregation is a far more com-

munal process in which entities must, from

an information integration standpoint, stand

on each other’s shoulders. Each participant

in the supply chain receives necessary data

from a predecessor, then supplements this

with its own data. This data includes aggre-

gation data of the primary, secondary and

tertiary packaging. Aggregation is a maze

that can potentially involve not only the origi-

nal packager and various re-packers, but also

reimportation entities and parallel imports.

Back at the manufacturing facility, aggrega-

tion also presents challenges to packaging

line speeds, since it involves the labeling

and tracking of packaging hierarchies. Dis-

cerning among various manual, automatic

and semi-automatic aggregation methods

will invariably require time and expertise to

define line throughput obstacles and, from

there, mitigate them as best as possible to

maximize overall equipment effectiveness

(OEE). Here, the wide-ranging factors — as

well as their relatively recent appearance on

the production landscape — place vendors

with sufficient aggregation experience at

a premium.

BY NOT AGGREGATING NOW, YOU’RE LIMITING CUSTOMER AND PARTNER POOLSThere are far more reasons to aggregate

than “because the FDA said so.” Aggrega-

tion does the following:

• Enables manufacturers to cater

to multiple countries’ track and

trace requirements

• Empowers supply chain stakeholders to

significantly improve warehousing and

inventory management

• Allows for simplified shipping, commis-

sioning and decommissioning of cases

and pallets



• Provides complete visibility into product

recalls and returns

• Increases transparency throughout the

supply chain

• Allows geo-fencing/geo-tracing of prod-

uct within the supply chain

Many U.S. distributors have recognized this

and redefined their rules of engagement

accordingly, preferring to do business only

with pharma companies who have, at least

to some degree, adopted aggregation

elements. And as the number of pharma

distributors requiring partners to be

aggregation-ready continues to grow,

the further behind pharma companies

who haven’t begun the process will be

— because getting up and running takes

time, training and an extensive trial-and-

error approach.

Implementing aggregation requires signif-

icant end-of-line alterations, introducing

new machines and checkpoints, creating

associated processes and educating opera-

tors on new procedure. Often, aggregation

will entail additional operator intervention,

which increases process time and batch

rejections and, therefore, affects overall line

output. Aggregation also restricts multiple

existing packaging processes, as well as

certain reconciliation methods. Finally, SOPs

and solutions to exceptional situations must

be realized and settled upon.

In short, aggregation is increasingly

becoming an exclusive club, and gaining

membership requires significant time, train-

ing and money.

DATA: THE GOOD, THE BAD AND THE NECESSARYLike serialization, implementing aggregation

will produce troves of new data. Some of it

is obligatory, some of it seems like spillover.

But all of it can be advantageous if prop-

erly translated into actionable intelligence.

The potential benefits have coined a new

industry term: “value beyond compliance,”

alluding to means of leveraging mined data

for operational efficiency, marketing, con-

sumer touchpoints, etc.

At its core, the point of aggregation is

inter-partner transparency. Aggregation

allows various invested entities along

the supply chain to verify that collabo-

rators are on the level and on the ball.

The results are living, breathing account-

ability documents — digital databases of

There are numerous reasons why pharma companies should aggregate now rather than panic later.



who did what and when to products with

common stakeholders.

But the data produced for aggregation

compliance also has value at its source: the

manufacturing plant.

First and foremost, the data produced by

aggregation can be used to reclaim some

of the OEE lost to aggregation. Aggrega-

tion is, like any new element added to a

packaging line, likely to cause some slow-

down. However, by properly capturing and

analyzing the data that this new system

provides, some speed can be recovered by

understanding where the slowdowns are

occurring and, to the extent possible, rec-

tifying mini situations that can add up to

significant sticking points.

It’s simple: The same tools required for

pharma companies to “show their work” to

partners can be utilized to reveal potential

for increases in efficiency within the pro-

duction plant itself. This comprehensive

approach to data is at the core of Pharma

4.0 “factory of the future” technology. It’s

where the industry is going — why not get

there sooner rather than later?

THE BEST VENDORS WILL HAVE LONGER LEAD TIMES AS 2023 APPROACHESThe last thing pharma companies want to

do is…well, be last.

As the November 2017 date for unit-level

serialization compliance neared, pharma

companies found themselves in a worst-

case game of hurry-up-and-wait: a looming,

mission-critical mandate with lead times

from industry-leading vendors that far

exceeded the deadline. In fact, even the

extra year’s extension didn’t clear the

capacity logjam that understandably trans-

pired. For an effort of this magnitude and

EXHIBIT 2

Packaging steps

Primary packaging

Secondary packaging

Bundle

Carton/Case

Pallet

1

2

3

4

5



expense, pharma companies wanted to

partner with trusted vendors; in fact, many

of those that didn’t, for lack of time or

resources, wound up with inferior products,

service or even suppliers that went out of

business shortly thereafter.

The runup to 2023 will be no different.

Pharma companies happy with their seri-

alization systems have no reason to delay

reengagement for aggregation. Companies

unhappy with their vendors have even less

reason to delay: Now’s the time to find a

vendor who is up to the task.

Implementing something as comprehen-

sive as aggregation requires experience

on several levels. First and most obvious, a

vendor should have exemplary aggregation

hardware and software products, and have

an existing customer base that can attest to

that quality.

Next, since aggregation impacts the entirety

of a packaging line, vendors with experience

in overarching line integration have a leg up.

Among other benefits, these partners have

experience training personnel to significantly

minimize per-item aggregation cycle times.

Last but not least, remember that the U.S.

isn’t the first to the aggregation dance. Even

if they aren’t the biggest names in America’s

track and trace market, vendors originating

overseas but with significant presence in the

U.S. are worth considering. Companies that

are headquartered in a nation that already

has successful aggregation requirements

and that cater to global pharmaceuticals

exporters have experience outfitting packag-

ing lines with aggregation that complies with

country-specific guidelines from around the

world. That sort of flexibility and familiarity

are big benefits for U.S. pharma companies

with international aspirations.

The potential benefits of aggregation have coined a new industry term: “value beyond compliance.”



Supply chains are disrupted,

operations shut down and

businesses around the world are

working out of home offices. Challenged by

an array of unprecedented circumstances,

pharmaceutical manufacturers are

perhaps facing the greatest burden during

this pandemic.

Like all companies, pharma manufacturers

restricted in how they operate under the

“new norm,” but yet must still ensure life-

saving medications are safely and rapidly

available to those in need. And that’s

not to mention the massive demand and

resulting mad dash to roll out potential

vaccines and new treatments to combat

the spread of COVID-19. The goal, of

course, is always to keep people healthy

and safe.

In this regard, labeling should not be over-

looked, and in fact, plays a more critical role

than ever before. It is an essential tool to

ensure patient safety and supply chain trace-

ability. It should also never be a barrier to

ensuring accurately packaged goods reach

those who need them as fast as possible. So

why do so many companies have a labeling

problem, and what can we do to fix it?

THE NEED FOR EFFICIENCYAlthough labeling is critical to the accuracy

and efficiency of pharma industry supply

chains, the fact of the matter is many phar-

maceutical manufacturers have limited

central oversight and control over their

labeling. For years, companies have used

legacy label design and print solutions that

are disparate across an organization or

supply chain, and not specifically designed

Improving supply chains in crisisBest practices for modern label management

By Lee Patty, Vice President and General Manager, NiceLabel Americas



https://www.nicelabel.com/

to holistically manage the entire labeling

process. The end result is a lack of labeling

harmonization that can seriously hinder

supply chains at the production level.

To improve on manual processes, many

companies have implemented semi-auto-

mated systems that focus only on certain

components of the production line, but do

not fully integrate processes across their

operations. Often, this results in a patchwork

of unstandardized practices and manual

workarounds such as paper-based quality

assurance processes or “sneakernet” prac-

tices, where data is physically transferred via

a removable media like USB drives instead of

on a centralized location over the network.

Additionally, these solutions segregate pro-

cesses like serialization and aggregation,

limiting the ability to track and trace items

effectively and delaying process improve-

ments by requiring extra print verification

on production lines themselves.

Unfortunately, these types of inefficiencies

quickly stack up, which leads to higher

costs and slower turnaround times and ulti-

mately delays critical drugs from reaching

patients in need.

THE DANGER OF NOT ADOPTING A STANDARDIZED LABELING SYSTEMWhile delays in the supply chain can be

detrimental, a slew of other issues can

also arise when using traditional and

dated methods of labeling. For instance,

as more human interaction is required,

there’s also a greater chance for human

error, which can result in anything from

mislabeled products to a massive recall.

The antidepressant Mirtazapine, for

example, was recently recalled because

bottles labeled 7.5 milligram may have

contained 15 mg tablets — putting both

the manufacturer and patient at risk. While

this type of error is potentially deadly, the

fallout from mislabeling a pharmaceutical

during a hectic crisis could be even

more catastrophic.

To help prevent recalls and improve

operations, while getting much needed

medications to their destination as quickly

as possible, here is what companies should

consider when moving to a modern label

management system, what to look for in

a modern system, and best practices all

organizations should follow to stream-

line labeling.

As more human interaction is required, there’s also a greater chance for human error, which can result in anything from mislabeled products to a massive recall.



MIGRATION PAIN POINTS Serialization and aggregation:

Pharmaceutical manufacturers have

had to comply with regulations around

serialization for some time, but many

countries are beginning to implement

new rules around aggregation — keeping

records of all the serial numbers and the

relationships between them. Beyond

compliance, aggregation also plays a

pivotal role in improving supply chain

visibility, providing a clear line of sight

without having to take the time to unpack

pallets and boxes as they move between

manufacturers, wholesalers and retailers.

Every label variant that must be printed

at an aggregation station needs to be

test printed and verified. Today this is

predominantly done on the production line,

if there is no centralized system in place.

Further complicating matters, the line

cannot run during this process.

Dislocated networks and printing

problems: Older or custom systems

often only support specific types of

label or marking printers — this is a big

problem when different facilities use

printers from different manufacturers.

It’s also common for facilities to use

completely different labeling software

for serialization and aggregation. This

can quickly result in compatibility issues,

major roadblocks and incurred costs.

Legacy sprawl: The adoption of different

labeling applications across facilities leads

to inconsistent label formatting and the

need to create the same label multiple times.

Additionally, IT may have to hard code

label designs and changes, user training

becomes increasingly complex, printer

integrations may have to be carried out by

subcontractors at the local level, and more

manual processes and human intervention

become necessary for labels to comply

with standards. All of this is costly, and

equally important, exposes organizations

to more potential labeling errors.

A BETTER, MODERN APPROACH TO PHARMA LABELINGClearly, there are a slew of challenges and a

growing need to harmonize labeling today,

but there is always a feasible path to address

an organization’s unique requirements. While

there is no one-size-fits-all solution, here are

some best practices any organization can

follow to improve labeling processes.

Ensure agility in the face of changing reg-

ulation: Today’s shifting landscape requires

the ability to rapidly adjust, and readjust, to

comply with changing regulations or cus-

tomer requirements. This is one area where

a harmonized approach to labeling can be

highly beneficial.

Audit trails can be easily followed in a

detailed, searchable record that indicates



where and by whom a label was originated,

changed and printed while data entry and

quality control processes can be auto-

mated and customized for customers. This

reduces risks of recalls from human error

and minimizes duplicate efforts. All these

improvements streamline the supply chain

and prevent unwanted hazards, especially

in times of crisis.

Support flexibility with an easy-to-in-

tegrate solution: Both label printers and

thermal inkjet printers can be seamlessly

integrated with any business system. This

means supporting automated printing

workflows, while remaining printer agnos-

tic across all locations. This will reduce the

need to replace hardware and will future-

proof the environment to welcome mobile

and IoT devices. Printing should also fit

seamlessly in, and scale alongside systems

like MES, ERP and WMS.

Use one system for serialization and

aggregation: An organization must be able

to govern a product’s labels as it moves

throughout the entire supply chain, includ-

ing serialization, where U.S. Food and Drug

Administration compliant individual unique

identifier labels are printed and verified

often at rapid speeds using thermal inkjet

printers, and on to aggregation, where

boxes and pallets are labeled with thermal

transfer printers before being shipped.

In this regard, a modern label management

system should integrate with serialization

and aggregation systems. It should decou-

ple the layout from the production line

set-up and handle the design and verifica-

tion process offline. It should also digitize

label approval workflows and automate

the deployment of the right layouts for the

right products to the lines. A modern label

management system should consolidate

universal label templates, and label lay-

outs should not require hard-coded printer

specific template files for serialization or

aggregations systems.

In summary, a label management system

should make packaging and aggregation

labeling easier for manufacturers, elimi-

nate the need to set up label designs after

hours, and require fewer verification runs

on the production lines altogether. This not

only helps organizations meet regulatory

requirements around aggregation, but it can

also dramatically increase efficiency. Con-

tract manufacturing organizations (CMOs)

A label management system should make packaging and aggregation labeling easier for manufacturers.



are implementing such systems ahead of

regulatory requirements to differentiate

and gain a competitive advantage from

their competitors.

Disaster can strike at any moment, but this

doesn’t mean you can’t be prepared. Before

choosing your next label management

solution, consider what matters most

for your business. What challenges are

you currently facing, and what are your

potential needs for the future? The right

label management solution will not only

enhance your operations today but can also

prepare you for whatever challenges arise

tomorrow.



2020 PACKAGING TRENDS - Pharmaceutical Manufacturing · 2020. 10. 6. · potential glass shortage,...

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Transcript of 2020 PACKAGING TRENDS - Pharmaceutical Manufacturing · 2020. 10. 6. · potential glass shortage,...