vi-SerieS High-performance inspection for ampules, vials and cartridges

In the pharmaceutical industry, quality standards are beco-ming more and more stringend. Increasing manufacturing ca-pacities are continuously leading to higher production speeds. As a result, highly sophisticated technologies are required to inspect product at all levels. Efficiency and detailed documen-ted information about the inspection process are key attributes that foster improved performance. Compared to other phar-maceuticals, the production of parenteral products is much more complex and bears the risk of many contaminations.

Since parenterals are typically injected and directly enter the bloodstream, particulates might cause adverse reactions. Another challenging aspect of container quality control is the assurance of container/closure integrity.

Whatever your requirements: inspection for particles in the product or cosmetic defects of the container, as well as verifi-cation of container integrity – we offer the appropriate inspec-tion technology for your needs.

Seidenader | 3

PuriTY and STeriliTY of ParenTeralS – viTal To PaTienTS’ HealTH

vi-SerieS

camera inspection

¡for particles

¡for cosmetic defects

le

ak

de

Te

cT

ion

leak detection

High voltage for micro-cracks and pinholes Laser for pressure in head space

aMPule

Particles

Sidewall

OPC

Tip

Bottom

Color Code Ring

Sidewall

Cap

Bottom

Particles

Beads

Plunger

carTridGe

Cap

Sidewall

Shoulder

CrimpStopper/Neck

Particles

Bottom

vial liQuid

Cap

Sidewall

Heel

Shoulder

Stopper/NeckCrimp

Bottom

Cake

vial lYo

17481500

800

4 | Seidenader

deSiGn feaTureS

vi-SerieS

24

1

3 6

CAMERA INSPECTION

¡Camera station with direct reject before the inspection carousel to avoid breakage of the containers in the machine

¡Continuous motion – no moving cameras, no moving lights – thanks to a central oscillating mirror moving in synchronization with the transport of the container

¡Servo drives for each position in the inspection carousel allow individual rotation profiles:

- Different kind of liquids require different rotation speeds to be brought into the dedicated motion - Different kinds of particles require different rotation speeds to be whirled up - Rotation speed and brake point are stored in the indivi- dual product configuration (recipe)

2 PRODUCT HANDLING

¡Vacuum transport for smooth product handling

¡Reduced number of side guides to avoid friction

¡Vacuum pump for reduced air consumption

“HySEPTIC” STANDARD

¡Sealed and covered optical elements

¡Column concept for good access and easy cleaning

¡Trimmed edges, hidden cables

¡Strict separation of product handling and machine engineering areas

¡GMP compliant

31 INfEED

Infeed via split timing screw which creates empty positions for the re-inspection process and stops infeed to empty machine without leaving uninspected products.

¡Manual loading from trays with Seidenader A-MAG, with tight splitting at infeed starwheel to slow down its rotation speed at same throughput

¡Inline interface with upstream machine to transport stable containers directly to the infeed timing screw

¡Inline connection, with turntable for manual loading

1800

2165

Seidenader | 5

5

7

7

4 AUTOMATIC RE-INSPECTION

Integrated re-inspection for defined defect categories

¡To minimize false reject rate

¡To avoid uninspected products during a production run

6 HEAD SPACE ANALyzER

Head space analyzer (HSA), for 100% testing of containers, inline and at high speeds, to verify container integrity of lyo-filled vials

7 OUTfEED

Each inspection result and each defect category can be allo-cated to a dedicated outfeed channel.

¡Up to 8 channels for good products, rejects or not inspected

¡Inline connection to downstream machine

5 HIGH vOLTAGE LEAk DETECTION

Integrated high voltage leak detection (HVLD PRO) for liquid filled containers, with one operator interface for camera and HV inspection – 360° inspection of the container guaranteed

All units are in millimetres.Footprint illustrated is example only.

¡Inspection of up to 36,000 containers per hour

¡Handling of ampules, vials and cartridges up to Ø 52 mm, and up to 100 ml

¡Inspection of solutions, suspensions, emulsions, oil-based and lyophilized products

¡Minimized false reject rate thanks to integrated automatic re-inspection of defined defect parameters

¡Maximized inspection performance thanks to - up to 24 images per particle station - up to 3 light techniques per particle station - up to 4 particle stations

¡Individual rotation profiles thanks to servo drives on each position in the inspection carousel

¡Large inspection turret to optimize rotation and inspection time, even for viscous and suspension products

¡Quick changeover thanks to fewer format parts

6 | Seidenader

vi-SerieS

The modular design of major machine functions for infeed, in-spection and outfeed enables us to build customized machi-nes from standardized modules. The VI platform is equipped as standard with vision systems for the inspection of solu-tions, suspensions, emulsions as well as oil-based or lyophi-lized products in ampules, cartridges and vials up to 100 ml. To complement camera inspection, additional technologies such as high voltage can be included, to reliably verify con- tainer integrity and product sterility.

Your BenefiTS

Seidenader | 7

Seidenader vi-60

36,000

13 (8)

72

up to 52 mm

ampules, vials, cartridges

solutions, suspensions, emulsions, oil-based and lyophilized products

yes

yes

long and short available

1,500 x 1,950 mm

yes

Seidenader vi-40

24,000

13 (8)

72

up to 52 mm

ampules, vials, cartridges

solutions, suspensions, emulsions, oil-based and lyophilized products

yes

yes

long and short available

1,500 x 1,950 mm

yes

max. throughput containers/h

max. number of camera stations (in carousel)

servo-driven positions in carousel

range of container Ø

range of containers

range of products

gross defect camera and reject station

combo machine liquid and lyo

automatic re-inspection

dimension of base machine (excl. cabinet)

vacuum transport technology with external electrical vacuum pump

TecHnical daTa

Sei

dena

der

04.2

014

www.seidenader.com

Seidenader Maschinenbau GmbHLilienthalstr. 8 · 85570 Markt Schwaben · Germany · www.seidenader.comT +49 8121 802-0 · F +49 8121 802-100 · info@seidenader.de

Seidenader ServiceS Tailored To Your needS

Seidenader customer SupportOur Customer Support Team is available during business hours to help you with urgent questions you may have about your Seidenader machine or any other technical issues. 24/7 support is also available as an additional option.

Seidenader after Sales ServicesMaintenance, spare part orders or retrofit requests – your direct contact is a designated customer support team to coordinate all your inquiries regarding our comprehensive range of after sales services.

Seidenader academyReduce your installation time to a minimum by taking advantage of custom-ized training sessions for integrators and users of our products – from the basics to the tips & tricks to run your machine in the most efficient way.

Seidenader Qualification SupportProfit from our validation support package and minimize validation and start-up time. Our specialists develop test plans and qualification protocols and provide support during execution.