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

4

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.

6

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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