Less unnecessary rejects thanks toautomated inspection.
THE CHALLENGE

formulas,” says Philippe Truelle, CEO of

Against the background of rising com-

CDM Lavoisier in the company’s mission

plexity in products and requirements,statement. And they not only develop new

the pharmaceutical manufacturer CDM

technologies; they also adopt them. After

Lavoisier decided to fully automate itsvery positive experience with several in-

inspection process for injectable glass

spection machines and further filling and

The increasing variety andampoules. Since 1888, CDM Lavoisierpackaging technologies from Syntegoncomplexity of parenteral drugs calls

has operated as a family-owned businessTechnology (formerly Bosch Packaging

for new dimensions in quality

and is a leader in the manufacturing ofTechnology), the company decided to relyassurance. Fully automated inspec-

injectable drugs. “Since the beginning,

on a new, fully automated solution fromtion technology with a combination

we have developed products according

the long-term partner. “The AIM 3000 isof visual inspection and container

to the needs of healthcare professionals

a new-generation, high-speed machineclosure integrity testing (CCIT)

and sick people. We are committed to top

which has the capacity to detect very

offers the highest product and hence

quality for the safety and efficiency of oursmall particles and a wide range of cos-patient safety. Pharmaceuticalproducts. It is with this state of mind that

metic defects,” says Mr. Truelle.

manufacturer CDM Lavoisier deci-

we regularly develop new packaging andCDM Lavoisier relies on
new AIM 3000 from
Syntegon Technology

ded to change their inspection processes for no less than 30 products
in four different packaging formats.

ENSURING PROCESS

They are now all inspected on theCONSISTENCY, SPEED AND“Nevertheless, the main challenge was tonew AIM 3000 from Syntegon

COST EFFECTIVENESS

optimize particle detection rates and re-Technology.

To date, the pharmaceutical manufacturer

duce false reject rates within the system.”

had been working with a combination ofSince many different parameters suchautomated and manual inspection. Ac-

as viscosity, density, fill volumes or thecordingly, one of the requirements of thepresence of bubbles can affect process

new system was its capability to execute

performance, it was crucial to evaluate

the previous manual inspection steps

the performance of the system based on

fully automatically, i.e. cosmetic defects

a wide range of process parameters andlike the so-called black spots originating

solution properties in order to qualify a ro-from the ampoule closing process, asbust and consistent visual inspection pro-well as non-moving particles within thecess. Once this challenge was overcome,containers. “Fully automated visual in-a large variety of inspection recipes had

spection offers several advantages, suchto be implemented and fast changeovers

as process consistency, speed and costensured for some 30 different products ineffectiveness,” says Mr. Truelle.

four packaging formats.

Comprehensive inspection
enables end-to-end qualitycontrol

AIM 3000: COMPACT

at an output of up to 450 containers per

PLATFORM FOR VISUAL

minute. To sort out damaged containers

INSPECTION AND LEAK

before they enter the main inspection

DETECTION

turret, the AIM 3000 is equipped with a

For CDM, the AIM 3000 project not only

The first model of the AIM series was de-pre-inspection station. The core module

had a positive outcome on the efficiency

veloped by Eisai Machinery some 40 years

features a high-resolution CMOS camera

of inspection processes. Another im-ago. In 1985, the successful KLD series

with high-speed interface for particle andportant optimization was related to theusing high-voltage leak detection (HVLD)

cosmetic inspection, as well as a built-in

previous manufacturing steps. “The more

was introduced by Bosch Packaging

re-inspection function. The customizablesensitive and sophisticated the inspection

Technology. It detects leaks by measuring

platform can be retrofitted on site to add

process, the more you learn about yourthe electrical resistance of containers withfurther visual inspection stations or theprior production processes,” Mr. Truelle

conductive solutions. Today, both tech-

HVLD module – which is exactly whatexplains. “Thanks to the information wenologies are an integral part of Syntegon

CDM Lavoisier opted for. “The AIM 3000

obtained from the AIM 3000, we were able

Technology’s inspection portfolio, andnot only offers us high speed, but also ato systematically identify and adapt crucial

the AIM 3000 combines both further de-

reduced footprint thanks to its integrated

sections within our filling and sealing pro-veloped visual inspection from the original

HVLD module,” Philippe Truelle under-cesses, to make them more stable and toAIM series and HVLD from the KLD series.

lines. Moreover, it equips CDM Lavoisierreduce the number of unnecessary rejects

The new platform inspects ampoules andfor the current and upcoming requirementseven further. In fact, our performance isvials containing solutions and suspensionsof EU GMP Annex 1.

increasing from week to week.”
CDM Lavoisier has successfully managed

TECHNOLOGY AND PROJECT MILESTONES

the technology shift in its inspection ofFor Philippe Truelle, the highlights of the new technology are obvious: “First, the HVLD

glass ampoules. “We are still in a con-module really works for all products, including Water for Injection (WFI). And second,tinuous improvement process. But wethe mechanical aspect of the equipment leads to significantly reduced glass breakage

can definitely confirm that the Syntegon

rates during the process.” Syntegon’s transportation technology relies on the Bernoulli

inspection technology and the entire

principle instead of transporting containers via a star wheel using vacuum grippers.

AIM 3000 project has led to major impro-

This principle allows for contactless handling of glass containers without mechanicalvements. After 25 years of successful

stress. In the unlikely event of glass breakage, no glass splinters will be sucked into

cooperation, we were already familiar withformat parts or the pneumatic system. Despite all the sophisticated technology, several

the professional and future-oriented wor-

steps were required to implement the AIM 3000 with the ideal settings for CDM Lavoi-

king methods. This very demanding pro-sier. “The Syntegon team tackled each challenge. It was a real partnership between ourject with its thorough project management

two companies,” says Mr. Truelle. The first major milestone consisted in selecting goodand efficiency has once again convinced

and bad samples for each of the 30 plus products. The Syntegon inspection experts

us of their qualities as a reliable partner,”tested all of them offline and developed the suitable inspection recipes. Then came thePhilippe Truelle concludes.

machine layout validation, the Factory Acceptance Test (FAT) in Germany, followed by
the re-installation and machine instruction training at the CDM site in France, including

Ralf Weihbrecht

Installation and Operational Qualification (IQ/OQ). “Finally, it was time to see whether

Syntegon Technology

the new equipment really is more efficient and effective than the previous combination

Email: Ralf.Weihbrecht@syntegon.com
Phone: +49(7151)14-2489

of automated and manual inspection,” Mr. Truelle recalls.