Brief description
Water-bath type sterilizer of oral liquid and injection solution uses high temperature circulating water as sterilization medium.It is mainly used in water-bathing type sterilizing operation and leakage detection washing treatment of injection, oral liquid and other products. After pure water circulated by water pump and heated by plate heat ex-changer,it performs sterilizing program in the manner of spraying.This equipment takes advantages of good temperature evenness,wide temperature adjustment range (80-126℃). At the same time, it avoids the second pollution in the work process.
The name and type of the equipment
This series of water shower ampule (oral liquid) leak test sterilizer adopts high temperature circulating water as sterilization medium, which is mainly used for water spray sterilization, leak detection, and cleaning treatment of injection and oral liquid, such as ampules, vials and tube bottle.Its temperature evenness is good, and temperature control range is wide (80-126 ℃). Vacuum leak test plus color water test insure 100% waste check rate.Temperature time and Fo dual control meet the requirements of pharmaceutical.
Technical specification
(1)Chamber
| A. Parameters |
| SN | Content | Parametric description |
| 1 | Chamber type | Rectangular |
| 2 | Door type | Motor driven sealing door |
| 3 | Open direction | From right/left side
(depend on customer’s requirement) |
| 4 | Number of Door | Two leafs door |
| 5 | Finish | Ra≤0.6µm |
| 6 | Planeness | ±0.5mm/m |
| 7 | Validation port | DN40 clamp connection |
| 8 | Relief valve (chamber) | Stainless steel 0.24Mpa open |
| B. Configuration |
| SN | Content | Type/specification/material | Number |
| 1 | Chamber | AISI 304 stainless steel,6mm | 1 |
| 2 | Dimension of Chamber | 3340x1000x1200mm(L*W*H) | / |
| 3 | Door base plate | AISI 304 stainless steel,10mm | 2 |
| 4 | Sealing strips for doors | Silicone rubber | 2 |
| 5 | Landing leg | AISI 304 stainless steel | 1 |
| 6 | Insulating layer | Aluminium silicate wool 30mm | 1 |
| C. Advantage and feature |
| 1. Ensure the finish of chamber surfaces, and then ensure the asepsis requirement. |
| 2. International advanced nozzle design of 3D more accords with the requirements of thorough sterilization. |
| 3. Doors have high intensity and can be able to bear the long term usage. |
| 4. Doors are processed by machining which can ensure the demanding level. |
| 5. Special sealing strips for doors can prevent ponding which more accords with the asepsis requirement. |
| 6. Chamber, doors are all carried out the leak test by helium mass spectrometer. |
| 7. All the pipes which link the chamber are pipes which accord with sanitary standard, and they accord more with asepsis requirement. |
8. A filter screen set near the outfall.
|
| 9. Use high quality safety valve and ensure the safe performance of machine |
(2)Rack and decorative sheet
| A. Parameters |
| SN | Content | Parametricdescription |
| 1 | Rack | AISI 304 stainless steel |
| 2 | Decorative sheet | AISI 304 stainless steel |
| B. Configuration |
| 1. Made by SSL, anti rust and more consistent with GMP requirement |
| 2. Provide wire drawing SSL plate surface coating, good anti scratch performance |
(3)Transfer system
| A. Parameters |
| SN | Content | Parametric description |
| 1 | Finish | Ra≤0.6µm |
| 2 | Planeness | ±0.5mm/m |
| B. Configuration |
| SN | Content | Type/specification/materia | Number |
| 1 | Sterile tray | AISI 304 stainless steel | 240 |
| 2 | Sterile vehicle | AISI 304 stainless steel;
size:810X920X1080mm | 4 |
| 3 | Transport cart | AISI 304 stainless steel | 8 |
| C. Advantage and feature |
| 1. Sterile tray/vehicle material is same as chamber internal to avoid sterile object pollution from contact. |
| 2. Easy to operate and docking. |
(4)Pipeline in air/steam/water
| A. Parameters |
| SN | Content | Parametric description |
| 1 | Standard | Stainless steel |
| 2 | Welding manner | Automatic welding |
| B. Configuration |
| SN | Content | Type/specification/material | Number |
| 1 | Pneumatic angle seat Valve | Germany Gemu | / |
| 2 | Air pressure regulator-filter | CAAP | / |
| 3 | Air filter | Lianyungang Santong | 1 |
| 4 | Throttling valves | CAAP | / |
| 5 | Spray header | KMECO | / |
| C. Advantage and feature |
| 1. Pipeline and valves are made by 304 ; |
| 2. Pipeline and valves meet stainless steel standard, there is no corner docking; |
3. Automatic pipe 30% endoscopic examination, manual pipe 100% endoscopic examination. |
| 4. Drain valve normally open and then decive dry pure steam. |
(5)Exhaust / air-bleed pipe
| A. Parameters |
| SN | Content | Parametric description |
| 1 | Standard | Stainless steel |
| 2 | Welding manner | Automatic welding |
| B. Configuration |
| SN | Content | Type/specification/material | Number |
| 1 | Trap valve | Zhongzhi Jingong | / |
| 2 | Pneumatic angle seat valve | Germany Gemu | / |
| 3 | Check valve | Shanghai Donghai | / |
| 4 | Water-ring pump | NASH | 1 |
| 5 | Pipe water pump | WILO | 1 |
| 6 | Heat ex-changer | Alfa laval | 1 |
| 7 | Waterproof hammer valve | Germany Gemu | / |
| C. Advantage and feature |
| 1. Pipeline and valves are made by 304 ; |
| 2. Pipeline and valves meet stainless steel standard, there is no corner docking; |
| 3. All pipelines are welded by auto welding machine with 20% endoscopic, also can provide 100% endoscopic if required; |
| 4. Water-ring pump anti cavitation line is added to greatly reduce the ambient noise; |
(6)Control system
| A. Parameters |
| SN | Content | Parametric description |
| 1 | Control type | Manual and automatic |
| 2 | Technique setting | Recipe management |
| 3 | Authority management | Level 3 password protection |
| B. Configuration |
| SN | Content | Type/specification/material | Number |
| 1 | Temperature sensors
(The coldest point) | B+B,Pt-100. Hot resistance A Level.2 pcs in the chamber,1 pc at the discharge outlet. | 3 |
| 2 | Pressure transmitter | DANFOSS | 2 |
| 3 | Pressure gauge | Wuxi Huihua -1～5bar | 4 |
| 4 | Touch screen | Wuxi Tianren | 1 |
| 5 | PLC | Mitsubishi | 1 |
| 6 | Software system | OSR Master | 1 |
| 7 | Breaker | DELIXI | / |
| 8 | Minitype breaker | DELIXI | / |
| 9 | Switching power supply | DELIXI | / |
| 10 | Intermediate relay | DELIXI | / |
| 11 | Printer | Beijing Wei Huang | 1 |
| 12 | Paperless recorder | Wuxi Deyuan | 1 |
| 13 | Indicator light | DELIXI | / |
| 14 | Relay | DELIXI | / |
| 15 | AC contactor | DELIXI | / |
| 16 | Motor starter | DELIXI | / |
| 17 | Emergency stop switch | DELIXI | 2 |
| 18 | Key button | DELIXI | 1 |
| 19 | Normally open contact | DELIXI | / |
| 20 | Alarm light | Q.LIGHT | 1 |
| 21 | Relief valve | Yongan | 2 |
| C. Advantage and feature |
| 1. There are multiple passwords. |
| 2. One touch function for examination provides data protection for the health of autoclave. |
| 3. Sterilize and drying (switch the type between manual and automatic randomly). |
| 4. Switch the type between manual and automatic at any point randomly. |
| 5. The operation can be in the sterilizing room. And they have the interlock functions which prevent faulty operation. |
| 6. There is a hydraulic emergency button in sterilizing room. It can stop in an emergency. |
| 7. There are working state of all kinds of parts and valves and parameter display of temperature and vacuum degree on the friendly human machine interface. |
| 8. There is a function for displaying various trouble points on the operation interface. |
| 9. Software system accords with FDA 21CFR PART II/GAMP5/China GMP 2010 version. |
