MS-SerieSHigh-performance inspection for ampules, vials and cartridges

2 | Seidenader

MS-SerieS

PuriTY and STeriliTY of ParenTeralS – viTal To PaTienTS’ HealTH

Increasing manufacturing capacities are continuously leading to higher production speeds requiring highly sophisticated technologies to inspect product at all levels. Compared to other pharmaceuticals, the production of parenteral products is much more complex and bears the risk of many contami-nations. Since parenterals are typically injected and direct-ly enter the bloodstream, particulates might cause adverse

reactions. However, one of the most challenging aspects 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 veri- fication of container integrity – we offer the appropriate in-spection technology for your needs.

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

Seidenader | 3

¡Inspection of up to 24,000 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 3 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

Your BenefiTSThe modular design of major machine functions for infeed, inspection and outfeed enables us to build customized machines from standardized modules. The MS platform is equipped as standard with vision systems for the inspection of solutions, suspensions and emulsions as well as oil-based or lyophilized products in ampules, cartridges and vials up to 100 ml. To complement camera inspection, additional tech-nologies such as high voltage can be included, to reliably verify container integrity and product sterility.

850

1010

1500

4 | Seidenader

deSiGn feaTureS

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

3 CAMeRA INsPeCTION

¡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)

1 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

1 2

MS-SerieS

1400

1400

400

9801400

Seidenader | 5

4 AUTOMATIC Re-INsPeCTION

Integrated re-inspection (short) 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 or HVLD SLIM) for liquid filled containers, with one operator interface for camera and HV inspection – 360° inspection of the con-tainer guaranteed

3

4

57

6

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

1050

Seidenader | 7

TecHnical daTa

Seidenader MS-40

24,000

9 (6)

60

up to 52 mm

ampules, vials, cartridges

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

yes

short

1,400 x 1,900 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

combo machine liquid and lyo

automatic re-inspection

dimension of base machine (excl. cabinet)

vacuum transport technology with external electrical vacuum pump

MS-SerieS

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

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