Auto-injector assembly:
Flexible and scalable production is key.
PCI Pharma Services
relies on RDA
assembly machinefrom Syntegon
TechnologyTHE CHALLENGE

replaced by technologically advanced auto-in-The injectable drug delivery market has expe-jectors. This development also stems fromrienced a paradigm shift in recent years. Due

the fact that self-injectable medicines are noto drastic changes in lifestyle and the accom-

longer used only for diabetes treatments orpanying increase in chronic diseases such as

growth hormone therapies, but also for thediabetes, the demand for injectable drugs has

increasing number of available parenteral bio-

been growing for decades. This transformation

therapeutics in oncology. Since multiple doses

relates not only to the quantity, but also to theare needed over time for these therapies, it isSelf-administration of drugs is on

way in which injectable drugs are delivered to-easier for patients if they can self-administer

the rise – due to a drastic surge inday. The traditional self-injection devices, suchthe medication at home rather than having tolifestyle-related diseases, as well

as standard syringes, are frequently being

attend several doctors’ appointments.

RISING DEMAND FOR

generation of medication. Although many

SELF-ADMINISTRABLE DRUGS

injector types have similar components, theiras major advances in oncology andhormone therapy. Thanks to theuse of auto-injectors, today patientscan be treated, or rather treat them-Auto-injectors are already standard equipment

design varies in terms of size, material andselves, more independently andwhen it comes to medical emergencies, suchshape. This is a major challenge, especially forautonomously than ever before. In

as the immediate treatment of an allergic

contractors and service providers that produce

contrast, pharmaceutical companies

shock. All application areas have one thing in

auto-injectors for pharmaceutical companies

and service providers are facing acommon: auto-injectors help avoid the com-worldwide and therefore have to assemble anumber of challenges when it co-

mon risks associated with self-administration

wide variety of differently shaped auto-injec-

mes to the assembly, labelling andvia syringes, such as incorrect dosages andtors. Biopharmaceutical service providers likepackaging of these devices. In ordermisuse, serious injuries and discontinuation of

PCI Pharma Services, with sites across theto meet the growing demand fortreatment. As a result of these developments,

globe, in Australia, the United States, Ireland

auto-injectors, they need production

the demand for self-administrable drugs andand the UK, rely on partners that are able toprocesses that are both time-effi-

the corresponding devices will rise evenprovide them with highly flexible machines tocient and customizable. Partners

further over the coming years – and so will thematch their individual requirements. Looking

such as Syntegon Technology

demand for corresponding manufacturing solu-for an opportunity to further expand their wide

provide extremely flexible production

tions. The rapidly changing market demands

range of production capabilities, PCI decided

equipment that can be used for thefor drug manufacturers to be highly flexible

to opt for the flexible Range Device Assembly

assembly and labelling of various

and to adapt their approach for this new(RDA) machine from Syntegon Technology.

auto-injector formats, allowing afaster time-to-market.„We will be able to efficiently
assemble auto-injector formats
that cover 80 percent of today’s
auto-injector market,” Blanton
explains. “What’s more, theRDA can easily and cost-effectively be retooled for future newauto-injector types. This allows
us to react quickly and efficiently to technological changes andto continue providing our clientswith excellent services, regardless of market volatility.” says
Chris Blanton.

FLEXIBILITY IS KEY

with an automated cartoner. The RDA fromPCI needed a solution that enabled them toSyntegon combines complex functionality withcontinue providing excellent service and custo-

a simple interface and safe assembly, including

mized solutions to their clients while also mee-systematic control processes and inspections

ting their own requirement for optimized equip-

to ensure consistent quality, as well as meeting

ment efficiency. “In our business, we need tothe device assembly instructions provided bymeet diverse customer demands, so flexibility isend customers. This provides operators withcritical to our success,” says Chris Blanton, Vicea good process overview for easy monitoring.

President and General Manager, Philadelphia,

The machine’s fixture design ensures correct

PCI Pharma Services. For Syntegon, this meant

placement of all autoinjector components duringthat the machine supplied had to allow fast andthe assembly, regardless of their size, material oreasy changeovers for any known auto-injector

design. The RDA is designed as a standardized,

type to ensure the necessary flexibility. At themodular assembly platform, which is specificallysame time, PCI needed to keep production

configured to meet customers’ needs in terms ofdowntime during format changeovers as short as

flexibility and capacity. It includes a fully automa-possible. Within their cooperation, Syntegon andted base machine with roundtable transport andPCI teamed up at an early project stage to define

12 to 24 process modules. The primary feeding

all the necessary parameters of the final equip-

section enables up to three operators to feed au-ment and develop a comprehensive concept toto-injector components from trays. The machine

expand PCIs services and meet their customers’is further equipped with a fully automated syringeneeds. To define the project scope, the partners

feeding section and a syringe inspection module,

first had to clarify which current auto-injector

as well as a secondary feeding section similar totypes the machine must be able to assemble andthe primary one. A labeling unit with laser-prin-which future types will be implemented at a laterting technology to print and verify variable data,stage. In the end, PCI and Syntegon decided toand a tray loading unit for the finally assembled,

go with the design that provides PCI the mostlabelled and approved auto-injectors round off

flexibility in the long run: a semi-automated RDA

the solution from Syntegon.

that will be used in the serialized line together

EFFICIENT PRODUCTION FOR HIGH-QUALITY RESULTS
The RDA’s key benefits are its ability to implement several auto-injector formats, and the rapid,
tool-free changeover time of less than two hours. “We will be able to efficiently assemble auto-injector formats that cover 80 percent of today’s auto-injector market,” Blanton explains. “What’s more,
the RDA can easily and cost-effectively be retooled for future new auto-injector types. This allows
us to react quickly and efficiently to technological changes and to continue providing our clientswith excellent services, regardless of market volatility.” The RDA also enables PCI to establish a
flexible assembly process with a minimum of downtime between batches, which ultimately resultsin cost-effective and faster production and delivery. Thanks to its automated and flexible alignment,
the machine’s utilization rate is very high, which offers PCI a high return on investment within ashort time frame. The RDA’s modular design also allows future adaptations and retrofitting, like thepossible integration of robotized production systems, with only minor adjustments. In line with
Syntegon Technology’s pharmaceutical line competence, the RDA can be complemented withfurther equipment for container handling, inspection, labeling and packaging. “Thanks to the newmachine, we can monitor all critical processes and are able to ensure that the devices are

Chris Blanton, Vice President and General

assembled correctly so that they perform as expected in the field to make patients’ self-administrati-Manager, Philadelphia, PCI Pharma

on as convenient and safe as possible,” sums up Blanton.

Services.

Syntegon Technology A/S
info-san@syntegon.com+45 55 462 400
Elmevej 94262 Sandved
DENMARK
www.syntegon.com