KSZ Sterilizing & Drying Tunnel

Product Details

KSZ  Sterilizing & Drying Tunnel

This  machine is integral tunnel structure. It’s divided into three parts: preheating  zone, heating zone, cooling zone. It adopts hot air laminar flow sterilizing  principle to sterilize and depyrogenate containers in short time.  

When  the clean vials are sent to the Sterilizing & Drying Tunnel automatically,  they will be sterilized and dried in the airtight tunnel. After the vials are  preheated, they will go to the heating zone, the temperature will increased to  nearly 320℃(can  be adjusted) to do depyrogenation, then the vials will be sent to the cooling  zone to be cooled, and then be sent to the Auger Filling & Stoppering  Machine.

There  are 3 sets of shutter manual adjusting device: between preheat zone and  sterilizing zone, between sterilizing zone and cooling zone, between cooling  zone and filling room.

Preheating  zone

Air  speed in the preheating zone: 0.45m/s±20％

There  are medium efficiency filter, high efficiency filter and LAF fan in the  preheating zone, which can realize the 100 class LAF. The vials can be preheated  by some hot air from the hot zone, then some moisture can be getting rid of.  

1  sets of HEPA filter (H14) LAF device at the preheating zone, Dimensions:  370×457×150mm, equipped with 1 LAF fan with separate transducer to control.  

There  are 2 sets of differential pressure detection device in preheat zone: up and  down differential pressure of filter, differential pressure between preheat zone  and washing room.

A  temperature probe is equipped at the preheating zone. When the temperature is  higher than the upper limit of set point, the tunnel can stop heating  automatically to protect the high efficiency filter.

There  is a view window at the preheating zone, the state of the vials can be seen in  the preheating zone.

Heating  zone

Air  speed in the heating zone (in the room temperature) : >0.6m/s  

There  is HEPA filter, individual electric heating system, high temperature fan,  suction fan(to exhaust the humidity air at the front 200mm of the hot zone),and  fresh air supplying structure in the heating zone. The vials are depyrogenated  in the 100 class LAF with the principle of hot air laminar flow sterilizing.  

1  sets of HEPA filter (H13) LAF device at the hot zone, Dimensions:  610×457×150mm，which  is equipped with 1 high temperature fan with separate transducer to control,  adopts PLC temperature regulator and thermocouple, air flow distribution and  control device working properly to ensure the uniformity of the temperature.  

There  are 2 sets differential pressure detection device in sterilizing zone: up and  down differential pressure device of filter, differential pressure device  between sterilizing zone and washing room.

It  is equipped with 4 temperature detection sensors in sterilizing zone (one in  heating tube area, the others are under high temperature HEPA filter), and  detected temperatures under high temperature HEPA filter are sent to PLC for  record, and displayed on touch screen.

It  adopts stainless steel heating tube to heat, and phase shifting pressure  regulator to control real-time heating power of electric heating tube, which is  controlled through PID in PLC, to achieve temperature control. 

It  adopts new flow distribution technology. There are 3 flow distribution boards  between air outlet of high temperature fan and high temperature HEPA filter, to  improve uniformity of air supply. It is installed a set of positive pressure  chamber under filter for flow distribution to improve heat distribution  uniformity. There is an adjustable air return flow distribution board at air  return channel to guarantee heat distribution uniformity. 

Water  cooling type is adopted for the cooling of the high temperature fan. It adopts  water cooling method to cool bearing holder of high temperature fan. The cooling  efficiency has improved greatly. It not only extends the service life of  high temperature fan, but also be good for choosing high temperature lubricating  grease.

Coefficient  of thermal expansion for high temperature HEPA filter metal frame and superfine  glass fiber high density filter paper are different to avoid filter paper camber  in high temperature, it is designed to have clearance in middle and low  temperature. This clearance maybe causes leakage, which will affect 100 class  LAF effect. This machine increases a divided flow frame, and through the  negative pressure principle, divide infiltrated air, guarantees clean security  of filtrated air.

Temperature  control adopts segmented PID technology in sterilizing zone, which separates  sterilizing zone into numbers of intervals according to the quantity of high  temperature fan. In each interval, there is temperature control probe and  detection probe to realize temperature setting and controlling individually,  which can guarantee heat distribution uniformity, depyrogenation &  sterilization effect.   

There  are temperature alarm system at sterilizing zone, air supply port and heating  tube.

Once  the temperature is higher than limitation at those areas, tunnel will  automatically stop heating and stop.   

Cooling  zone

Air  speed in the cooling zone: 0.45m/s±20％.  

Medium  efficiency filter, high efficiency filter, ventilator and air exhausting fan are  put in the cooling zone to realize the 100 class LAF, and the vials are cooled  by the air sent from air circulation cooling system with heat exchanger. The air  speed difference between the cooling zone and hot zone not only keeps the  pressure between them, but also be a necessary jacking to the hot zone to ensure  the pressure in the hot zone not to fluctuate much.

The  cooling zone adopts water cooling method together with surface cooler. It adopts  air circulation cooling system with heat exchanger in cooling zone, which cools  air through cooling water, and cools vials with cooled air. Cooling air adopts  inner circulation method which can highly reduce demand of clean air and  mitigate air pressure fluctuation in clean room. 

Water  output volume of surface cooler is automatically adjusted through pneumatic  proportion regulation valve according to temperature of circulation air.  Adopting this structure, it can avoid condense water at too low temperature, and  also prevent overheating caused by too high temperature.

1  HEPA filter (H14) LAF device at the cooling zone, Dimensions: 610×457×150mm,  equipped with 1 LAF fan with separate transducer, and an exhausting fan at the  down side for inner laminar air flow cycling.

There  are 2 sets differential pressure detection device in cooling zone: up and down  differential pressure device of filter, differential pressure device between  cooling zone and washing room.

A  temperature probe is equipped at the cooling zone. When the temperature is  higher than the upper limit of set point, the tunnel can stop heating  automatically to protect the high efficiency filter.

There  is a view window at the cooling zone, the state of the vials can be seen in the  cooling zone.

It  divides tunnel and filling room through SS304 separating board.  

There  is a exhausting device, the equipment equip with blower, but the buyer has to  connect a corresponding pipes and blower. (800m3/h, 400Pa)  

Air  pressure auto balance system

Flowing  direction of LAF in tunnel is from sterilizing zone to preheat zone, from  sterilizing zone to cooling zone. Differential pressure distribution is: preheat  zone < sterilizing zone > cooling zone.

It  is equipped with air pressure self-balancing system, which can control air  pressure balance between cooling zone and filling room, pre-heating zone and  washing, sterilizing room effectively. When the air pressure has fluctuation, it  avoids influence to LAF and sterilizing effect.

There  is pressure monitoring device to detect pressure differential between washing  room and filling room and automatically alarm and stop the machine once the  pressure differential going too low or too high, which can prevent machine  running under over pressure state in order to ensure effective working of air  pressure balance system.   

Belt  conveying system.

It  adopts our self-made chain mesh belt (made by the CNC net-making machine), with  valid width of 400mm. The speed of the conveyor belt can be synchronized with  the Washing Machine, Auger Filling & Stoppering Machine. The speed is  adjusted by the transducer.

Conveying  belt adopts integral structure of connecting bottom belt and side belt through  chain, and adopts sprocket chain to convey, which guarantees synchronization of  bottom belt and side belt.

There  are several residue removing ports under mesh belt, tunnel and at the outfeed  site. It is easy to clean inside of the tunnel.

The  equipment has a pushing board made of mesh board. It is used at the start and  end of the production for supporting the vials and emptying the tunnel.  

Verification  Port

The  machine is equipped with DEHS/PAO port for HEPA filters integrity testing, and  in non-detection state, it is closed. It is equipped with air velocity detection  port, which is installed 3 inches below center of HEPA filter. It is closed in  non-detection state.

Control  system

HMI:  Proface, 10.4” color screen, the temperature at the heating zone can be set at  the HMI, and the temperature curve can be displayed on the HMI of PLC. The  temperature can be detected by the thermal couple. The sampling and record  interval is 30s (it can also be set by the buyer), the temperature can be kept  in the archive for 15 days for check and analysis. 

PLC:  Siemens

Electric  cabinet: Together with main machine, airtight. When power fails, the power  failure protection function is active. Which flushes the compressed air to the  heating zone to cool down the temperature in the heating zone in order to  protect the high temperature HEPA (we reserve a port for compressed air,  compressed air is supplied by the buyer) .

Electric  control panel: together with main machine, and connected with the electric  cabinet by wire. Equipped with touch screen, emergency button, it can display  the alarm, and reset by manual operation.   

Interlocking  device: interlocking with the upstream Washing Machine and downstream Auger  Filling & Stoppering Machine to show the cause of fault, position of fault  and simple solution. At the same time, it can show the active state of the fan  at different zones and conveyor motor.

Interlocking  with temperature: control circuit has interlocking device. When temperature in  the tunnel is lower than 100℃, it can cut off the power automatically. When the  temperature is higher than 100℃, all fans cannot stop running, to protect the  HEPA filter.

It  has day mode and night mode. Start day mode while producing. When no production,  selecting the night mode. In night mode, electric heating tubes don’t heating  and LAF fan run normally, which guarantees 100 Class LAF effect in chamber. It  meets aseptic production requirement.

It  is protected through 3 levels passwords: operator, engineer and administrator.  

At  start and end of production, vials will stay in sterilizing zone for 5 minutes,  which guarantees FH value of vials at start and end meeting requirement.  

Key  Words:

Pharmaceutical Machinery, Pharmaceutical Engineering,  Pharmaceutical Equipment,
Packaging Machinery, GMP Machinery, Pharmaceutical  Industry, Pharmaceutical Technology

cGMP Service, cGMP Solutions, cGMP  Validation