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Drying and Sterilizing Tunnel HQL Series
2
Sterilizing process, HQL series
The dry heat sterilization process
operating with the Laminar Flow principle
meets all requirements of the pharma-
ceutical industry.
In cooperation with leading pharmaceuticalcompanies, an economical process for thesterilization of containers for parenteraldrugs was developed which is for industrialuse, biologically definable and can be vali-dated. This process has found worldwideacceptance for many years.Dry heat sterilization by the Laminar Flowprinciple.
In scientific tests, both in laboratories aswell as in standard Bosch sterilizing tunnels,the biological effectiveness of the processwas verified with bio-indicators. A varietyof containers was used to define their steri-lization effects and the de-pyrogenization.This was developed into a logarithmicmodel stating that under the influence ofheat for a defined period of time an initialcount of bio-indicators will reduce by adefined value. Premise is a defined tempe-rature progression curve at the sterilizationobject in a defined time sequence and thecontrol of the biological effect of the heatinfluence (see diagram, Page 3).
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Method of operation with high process security
Method of operation:
Stable and non-stable containers arrivingfrom the washing machine are fed underLaminar Flow into the infeed section of thetunnel and are pre-heated.The containers are sterilized and de-pyro-genized in the heating section and thentransferred to the cooling section. At thetunnel outfeed, the containers are bulk-fedonto the infeed belt of the downstreammachine.
Validation of sterilizing tunnel by measur-
ing the temperature and inactivation of
bio-indicators (spores and pyrogenes) on
the sterilization object.
Process validation:
For proof and documentation that theapplied process reliably leads to the requiredresults within the specified limits, validationmust set in as early as in the stage of product development. When determiningthe process conditions, the margin laterrequired for process control must be takeninto account. The system should be devel-oped in such a way that the process para-meters are within meaningful, controllableand reproducible tolerances for futurerecourse in actual production and qualifica-tion to validation results obtained duringthe developmental stage. Additional advantages of the LF
sterilization process:
❒ No incorrect temperature readings duringheating of sterilization objects in air flow.
❒ Excellent, uniform heat distribution,❒ Possibility to determine, precisely keep
and reproduce optimum parameters,without the need for extra safety margins,for various container shapes and glassqualities.
❒ Inactivation of bio-indicators, use of temperature (energy savings).
❒ Economical, container-protecting sterilization process.
Published research results on Hot Air LF
Sterilization:
❒ "Validation of Dry Heat Sterilizers" in"Die Pharmazeutische Industrie" 6/1982,by Dr. L. Gail, K. H. Wallhäuser, M.Klavehn,
❒ "Practice-Oriented Requirements forTemperature Programs for Dry Heat Sterilization" in "Die PharmazeutischeIndustrie" 5/1984 by Dr. H. P. Hortigand Dr. L. Gail.
Checking and monitoring facilities:
❒ Pre-filter monitoring❒ Differential pressure indicator for
particulate air filters❒ Multi-channel recorder for temperature
and other process parameters❒ Trailing thermocouple for the
temperature measuring in the container❒ Conveyor belt stop in case of low
operating temperature❒ Temperature-controlled interlock of the
fans❒ Protection against overheating for each
heating register
Thermal inactivationSterilization object:2 ml ampoule (24000 units/h)
Vertically directed hot airLaminar Flow
Thermal inactivationSterilization object: Vial 10 R (6000 units/h).
Vertically directed hot airLaminar Flow
Control panel
Differential pressure indicator
Multi-channel recorder
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HQL 2000 – 3000 – 4000 modular system
Infeed
Heating section
Tunnel version with infeed, 1 heating section and 1 cooling section
The HQL modular system: For each
container the appropriate sterilization
program.
The various containers sizes and glass qualities mandate individual treatmenttimes for the sterilization and de-pyro-genization process. After scientific acknow-ledgement of the LF sterilization processand singularly unanimous approval in pro-duction application, Bosch developed amodular system for individual applicationswhich includes also a comprehensive pro-gram of additional modular assemblies.
Infeed Heating section
Cooling section
Cooling section
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The energy-saving air recirculation system
The energy-saving air recirculation
system – with Laminar Flow principle.
The choice of tunnel is determined by thesize of the containers as well as by therequired output. These parameters thusdefine the configuration of the tunnel withone, two, three or more heating and cool-ing sections, respectively.It goes without saying that the HQL tunnelswork synchronously in compact lines forthe processing of ampoules and other injec-tables:❒ With upstream washing machines for
ampoules, cartridges or vials❒ With downstream filling and closing
machines for ampoules, dental cartridgesor vials for injection.
Infeed
Heating section
Description of function:
Cooling section
Through a filter, make-up air is fed into thetunnel. Within the tunnel, air, drawn in byfans, feeds in the infeed and cooling sectionthrough pre-filters and particulate air filtersinto the separate zones of the tunnel. Byway of the Laminar Flow principle, the airflow is directed vertically onto the contai-ners. Below the conveyor belt, the air isagain directed through a recirculation ductto the fan.Fans serve to take in fresh air for the hea-ting section - Laminar Flow unit. Heatingelements in the recirculation duct serve toheat the recirculated air to the preset tem-perature. Below the particulate air filters arethermal elements with output to a tempera-ture control device and recording.The cooling section operates with LaminarFlow. A fan in the cooling section extracts theheated air below the conveyor belt. Theexhaust air volume is adjusted auto-matically.The tunnel is equipped with anautomatic excess pressure control in thecooling section.
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The conveying system HQL 2000 – 3000 – 4000
Special transport system for reliable and
gentle through-conveyance even of com-
plicated container shapes
The conveyor system consists of a horizon-tally revolving conveyor belt with two syn-chronized side guide belts and is made ofstainless steel mesh. It provides friction-free, gentle container conveyance throughthe operating section. Three different conveyor widths can be supplied. The conveyor system is controlled by the container accumulation at the infeed.Return travel of the belts is enclosed, outside of the operating section.
Tunnel infeed
Container outfeed of washing machine withtoothed belt (additional device).
Conveying system for non-stablecontainers.
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Easy access for service and maintenance.
The heating section is equipped with one orseveral service doors. Electric heating rodsare located at the inside of the doors. All filters are installed without gaskets into lowpressure chambers thus facilitating assemblyand disassembly.
Change of filter, infeed
Change of filter, heating section
Heating section
Change of filter, cooling section
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❒ Container-controlled partition wall ❒ Air recirculation cooling system with heat
exchanger❒ Air exhaust system below the tunnel out-
feed section❒ Fresh air cooling system with refrigerated
air connection, air conditioning unit❒ Sterilizable cooling section (with hot air)
Container-controlled partition walladjustment
Automatic overpressure control
Optional equipment HQL 2000 – 3000 - 4000
Dual circuit cooling system with heat exchanger
Cooling section sterilizable with hot air
Fresh air cooling system with refrigeratedair connection, air conditioning unit
Recirculated air cooling system with heatexchanger
Exhaust below tunnel outfeed
Other optional equipment
(not illustrated):
❒ Combination with compact line for Aka-septic or Isolator
❒ Additional thermoelements❒ Air flow meter in the cooling section with
display unit❒ Display of the conveyor speed❒ Automatic timer for night mode
operation.❒ Isokinetic nozzles for particle measuring.
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HQL 5000 – for large-volume vials
HQL 5000: The vial sterilizing tunnel from
the Bosch HQL modular system.
The qualified sterilization program for
every container size.
Operating method: Stable and non-stablecontainers arriving from the washingmachine are fed into the infeed section ofthe tunnel underneath a Laminar Flow unitand then pre-heated. The containers aresterilized and de-pyrogenized in the heatingsection and then transferred to the coolingsection. At the tunnel outfeed, the contain-ers are bulk-fed onto the infeed belt of thedownstream machine.
Heating section
Cooling section
Infeed
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The HQL 5000 transport system
Special transport system for safe and
gentle through-conveyance even of
complicated container shapes:
The conveyor belt is made of stainless steelmesh. It provides friction-free, gentle con-tainer conveyance through the operatingsection.
Heating section
HQL 5000 standard
Cooling section
Infeed
Transport system for stable containers
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Laminar Flow principle Easy service
Easy access for service and maintenance.The energy-saving air recirculation
system – with Laminar Flow principle.
The sterilizing tunnel HQL 5000 is designedfor larger size vials. Functionally and withregard to all advantages it corresponds tothe high technical standards of Bosch to theHQL 2000 – 3000 – 4000 series.Through a filter, make-up air is taken infrom both sides and fed into the tunnel.The heating section is equipped with doorson both sides, containing the heating regi-sters. Within the tunnel, air which feedsinto the infeed and cooling section throughpre-filters and particulate air filters into theseparate zones of the tunnel is drawn off byfans. By way of the Laminar Flow principle,the air flow is directed vertically onto thecontainers. Below the conveyor belt, the airis again directed through a recirculationduct to the fan.Electric heating elements in the recircu-lation duct serve to heat the recirculated airto the preset temperature. Below the filtersare thermoelements PT 100 with output fortemperature control and recording.The cooling section operates with LaminarFlow.A fan in the cooling section extracts theheated air from below the conveyor belt.The exhaust air volume is automaticallyadjusted. The tunnel is equipped with anautomatic excess pressure control in thecooling section.
Filter change (infeed, cooling section)
Filter change, heating section,change of heating element
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Optional equipment HQL 5000
Transport system for non-stablecontainers
Sterilizable cooling section (recirculating air) Sterilizable cooling section (recirculating air)
Cooling section with air recirculationcooling system
Overpressure control, cooling section
Further optional equipment:
❒ Transport system for non-stable containers
❒ Cooling section with air recirculation cooling system
❒ Sterilizable cooling section (with hot air)❒ Combination with compact line, also with
Isolator technology❒ Additional thermoelements❒ Air flow meter in the cooling section with
display unit❒ Display of the conveyor speed❒ Automatic timer for night mode
operation.❒ Isokinetic nozzles for particle measuring.
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Technical data HQL series
Dimensions LF tunnel
Series Length Width HeightHQL mm mm mm
2220 2225 1300 2330
2240 2875 1300 2330
2420 2865 1300 2330
2440 3515 1300 2330
3220 2225 1500 2330
3420 2865 1500 2330
3620 3510 1500 2330
3820 4355 1500 2330
3240 2875 1500 2330
3440 3515 1500 2330
3360 3520 1500 2330
3460 3820 1500 2330
3480 4620 1500 2330
3680 5265 1500 2330
Length
Panel
Heig
ht
Wid
th
Graphic illustrations in this leaflet are examples only! Determinant for the final execution, including technical specifications,is our individual quotation exclusively.
Subject to technical modifications.
All dimensions in mm.
Series Length Width Height
HQL mm mm mm
4360 3520 2040 2480
4480 4620 2040 2480
4680 5265 2040 2480
5120 4044 2500 2500
5121 4350 2500 2500
5131 5345 2500 2500
5230 6063 2500 2500
5240 7058 2500 2500
5241 7670 2500 2500
5251 8665 2500 2500
5340 8082 2500 2500
5350 9077 2500 2500
5360 10072 2500 2500
5351 8665 2500 2500
5361 10990 2500 2500
5371 11985 2500 2500
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Compact lines for vials
Vial compact line
Vial compact line
With competence and responsibility, Boschis leading in the manufacture of completelines: From function-compliant, technicallymatured individual machines and theirinterlinkage, to documentable production.The pharmaceutical industry relies moreand more on the capacity of the strongpartner Bosch in development, quality,know-how and service.
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Compact lines in Isolator technology
Ampoule compact line in Isolator technology
Vial compact line in Isolator technology
Robert Bosch GmbHPackaging Technology DivisionProduct Division Pharma LiquidBlaufelder 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: www.bosch.com/vt
Robert Bosch Ltda.Tecnologia de EmbalagemRua Dr. Rubens Gomes Bueno, 47804730-901 São Paulo-SP/BrasilTelephone ++55 11 5547 5709
++55 11 5547 5831Fax ++55 11 5547 5906Internet: www.bosch.com/vtE-mail: vtbr@boschpackaging.com
Bosch Packaging Technology K.K.Hatchobori NF Bldg., 4F2-21-6, HatchoboriChuo-kuTokyo 104 0032JaponTelephone +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: www.boschpackaging.com
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