MLD series for prefilled syringes and dental cartridges

MLD - the successfull basic concept for all applications.

The precise conveying system is an innova-tive and new development from Bosch forthe wide range of applications and require-ments in the processing of prefilled syringesand dental cartridges.

SMALLLINEAR

Fields of application:The broad processing range reaches fromprefilled syringes to dental or insulin car-tridges up to cartridges for contrast media.

Conveying system.

The construction of fill and seal machinesfor prefilled syringes and cartridges hasbeen a successful tradition at Bosch for over30 years. During this period 150 differentlydesigned machines have been supplied.With its Isolator technique Bosch is wellestablished on a path to the future. Themachines in the MLD series were developedas multi-function machines for the process-ing of prefilled syringes and cartridges incompliance with modern pharmaceuticalaspects. This was accomplished in confor-mity with the highest technical standards ofBosch and with the support of StuttgartUniversity.Maximum output can be adapted ideallyvia the variable number of work stations tosuit any need.The slim design of this machine enablesvery good accessibility to all the work sta-tions, which is particulary advantageouswhen using Isolator technique.The materials used are suitable for bothIsolators and decontamination.

800

Filling and closing of dental cartridges and prefilled syringes.

Exact, unchangeable pitch in the containercarrier, no change in pitch due to belt ten-sion or temperature.Exact horizontal guidance: roller/prismsystem, no belt sag.Clip system for prefilled syringe and car-tridge conveyance - no sliding - exposedtop and bottom.With the Bosch container carrier system thelength of the machine i.e. the length of theconveying system is technically problem-free.The combination of continuous and inter-mittent conveyance within the machineoffers functional safety for high outputspeeds (from approx. 18000/h).Continuous where it is advantageous:infeed, outfeed, filling and overseal cap ent-rainment.Intermittent where precise functions areimportant, e.g. for oversealing.

Depending on requirements the mode ofoperation of the new type of precision con-veying system is continuous or intermittent-ly synchronized with the correspondingwork station. It guarantees exact position-ing of the often very small container open-ings below the work stations, at the sametime causing minimal disturbance of thelaminar air flow.Rotary slide valves or computer-controlledtime/pressure filling systems come into question as the optional filling systems.Besides the filling module, the MLD can beequipped easily with a broad range of clo-sure variations thanks to its modular design.The MLD machine concept is thereforeoptimally suited for the deployment ofmodern and innovative packaging materi-als.Optical inspection stations can be integra-ted.

Filling systems.

Filling system with rotary slide valve pumps.

Fill and seal machine MLD.

Time-pressure filling system.

Filling system with rotary slide

valve pumps -

Technical advantage with therotary slide valve pump fromBosch:The reliable precision fillingsystem with wide ranges of vol-ume.3-sectioned: rotary slide valve,pump cylinder, pump piston.Rotary slide valve pumps use noseals.Best suitability for CIP/SIP.Easy, vertical cleaning paths.The filling process is made byrotating the slide valve and bythe pump stroke.No after-drip.

Time-pressure filling system - Advantagesof the time-pressure filling system:No need for an intermediate container atthe filler.The pressure and temperature monitoringsystem is located directly at the dosing posi-tion.Any regulation of pressure within very nar-row limits is not necessary since the pressureis continuously monitored and by way ofcalculation converted into the current fillingtime.The time-pressure filling system can beimplemented for all liquid products and isparticularly advantageous for– recrystallizing products – shear-sensitive products.Very easy CIP/SIP version possible.Cost-advantageous sizeparts (filling needles/valves/fill hoses)

MLD - for prefilled syringes: configuration adaptedto requirement.

Description of function:1 Loading the syringe body by means of

a transport puck2 Infeed and singularization of the

containers by means of a transport scroll

3 Separation of syringe body from the transport puck

4 Turning the syringe body upside down5 Apply Tip-Cap from below6 Gasflushing before filling 7 Filling the syringe8 Gasflushing after filling9 Insert stopper from the top10 Rejection of empty or non-complete

syringe bodies11 Final discharge

Description of function MLDfor prefilled syringes

Luer-Lok application station

Tip-Cap application station

Plunger inserting station

With the basic concept of the MLD all vari-ants for different prefilled syringes arebeing developed and built according torequirement.

Output up to 18000

syringes per hour.

MLD – for prefilled syringes: configuration adapted to requirement.

Return of the transport pucks. Time-pressure filling system in CIP/SIP version

Luer-Lok and Tip-Cap feed systems.

Up to 18,000 prefilled syringes per hour.

The state-of-the-art automation and preci-sion engineering involved in the sophistica-ted fabrication of prefilled syringes is simp-ly brilliant. The syringe bodies, which areloaded into transport pucks, are removed inthe feed area of the fill and seal machine.

The fill and seal machine consists of severalstations with up to 6 simultaneously operat-ing function points: an application stationfor a Luer-Lok-cap and a Tip-cap closure, afilling station with the time/pressure fillingsystem for fill volumes of 0.4 to 1.2 ml anddesigned for CIP/ SIP, an insert station fora plunger-type stopper and various inspec-tion and discharge stations. The work sta-tions are controlled via several servo-motors and stepping motors. Operator control is effected from the front side onlyand the mechanism is accessible from therear side.

Fill and seal machine MLD

MLD – for prefilled syringesin Isolator technique

Leading pharmaceutical companies havemade it their goal to bring innovative pro-ducts to the market and therefore rely onthe innovative Isolator technique fromBosch.In the pharmaceutical industry, the Isolatortechnique continues to gain widespreadacceptance due to its unique productionadvantages. Comparisons with standard ste-rile room techniques carried out by expertshighlight the clear trend in favour of theIsolator technique.The advantages of the protection featuresfor both operator and product make theIsolator technique the technology of thefuture. Bosch, with its dominant position insupplying the largest percentage of all Isola-tor lines on a global scale has thus consoli-dated its leading position as supplier ofchoice to the pharmaceutical industry.

MLD – for prefilled syringes with glued-in needle.

MLD 4040 with CIP/SIP, time-pressure fil-ling system, plunger-type stopper insertingstation, discharges, Isolator preparation.

Description of function:1 Infeed of prefilled syringes with

glued-in needle and needle puck 2 Time-pressure filling station3 Plunger-type stopper inserting station4 Discharge5 Outfeed for in-process control system

Fill and seal machine MLD4040 for prefilled syringes inIsolator technique.

MLD – fill and seal machines for dental cartridges.

Stopper insertion from below

Fill and seal machine for dental cartridges in Isolator technique

If you are planning cartridge production forthe future, Bosch is just the right partner foryou.The multitude of installations delivered byus provide ample evidence of our manysatisfied customers.The fundamental concept of the MLD pro-vides the standard construction on whichall customized variants are based.The low-particle oversealing deserves spe-cial mention. The machine design providesoutputs of up to 36,000 cartridges per hour.

Lines with a future: up to 36,000 dental cartridges per hour.

Stopper inserting station. Ball dropping station.

Time-pressure filling system. Overflow station.

Intermittent overseal station for aluminumcaps.

Double-discharge of dental cartridges fromthe Isolator.

MLD – fill and seal machine for dental cartridges.

Bosch has the largest percentage of all sup-plied filling and closing machines in Isola-tor technique due to their technical lead,safety and reliability as well as maximumquality standard.

Fill and seal machine MLD 5120 for dental cartridges in Isolatortechnique.

Isolator technique from Bosch: Technology of the future.

With the greatest experience and know-how, modern development and high tech-nical standard Bosch has proven its leadingposition in the Isolator technique.Highest and most economical level ofClean Room technique.Smallest possible Clean Room for the fil-ling process.Maximum requirements with regard to pro-tection of personnel and product have beenmet.The danger of contaminating the drug dueto human presence has been eliminated.The filling process can be presented as anenclosed process.Decontamination of the Isolator interiorwith H2O2: a process which is validatable,reliable, and environmentally friendly.

Fill and seal machine MLD 5120 for dental cartridges in Isolatortechnique.

MLD – work stations, prefilled syringes.

Turntable infeed: transport pucks with inserted syringe bodies.

Tip-Cap application station.

Time-pressure filling station in CIP/SIP ver-sion.

Rubber stopper orienting and insertingstation.

MLD through-conveyance

MLD in Isolator version for prefilled syringes with glued-inneedle, time-pressure filling station in CIP/SIP version andrubber stopper orienting and inserting station.

MLD –- work stations, prefilled syringes.

MLD through-conveyance

Emplacing plastic closures

Rotary slide valve pump filling station

Fully automatic in-process checking station.

Rubber stopper inserting station.

Robert Bosch GmbHPackaging Technology DivisionProduct Division Pharma SolidsBlaufelder Straße 45D-74564 Crailsheim

Postfach 14 54D-74554 Crailsheim

Telephone +49 79 51 40 2-1Fax +49 79 51 40 2-2 58E-mail: vt@boschpackaging.comInternet: http://www.bosch.de/vm

Bosch Packaging Technology K.K.Hatchobori NF Bldg., 4F2-21-6, HatchoboriChuo-kuTokyo 104 0032JapanTelephone +81 3 3206 2821Fax +81 3 3206 2822E-mail: vtjp@boschpackaging.com

Bosch Packaging Technology NAPharmaceutical8700 Wyoming Ave. NMinneapolis, MN 55445-1836USATelephone +1 763 424 4700Fax +1 763 493 6711E-mail: pharm-na@boschpackaging.comInternet: http://www.boschpackaging.com