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Sterilization Services

In order to give a customer“Safety”, Taisei adopts the most suitable sterilization for the product from 3 kinds of sterilization method.

The most important thing in a production of pharmaceutical/cosmetic packages is to know whether the product is safety or not. Taisei Kako performs the most suitable sterilization services from 3 kinds of sterilization method. Our attitude to the sterilization is to give safe quality to a customer by our high technology and updated facilities.

Characters of Sterilization method, Suitable/unsuitable materials for the sterilization

  Electron Beam Sterilization Vaporized Hydrogen Peroxide Sterilization Ethylen Oxide Gas Sterilization
Materials PS,ABS,PE,PA,PET,Si,Natural Rubber, PUR,PI,SAN,Epoxy Resin,PSU,Phenol Resin, AL
・Glass,PC,PVC and COP : Be cautious of change in color.
・POM,Fluorocarbon resin and PP: Be cautious of degradation of strength.
PE,PP,COP,Glass,Si,PTFE
・PA,Cellulose,PUR and ABS are unsuitable because of easy-to-absorb the sterilization agent.
Almost all materials are possible to sterilize.
Shape of product ・Tightly sealed product is possible to sterilize.
・No restriction on the shape of product.
・High density and small product is preferable.
Simple shape of product is preferable such as bottle, cap, nozzle, barrel and plunger. ・Since the sterilization agent has highly osmotic force, there is almost none of restriction on the shape of product.
・Corrugated box is usable for the purpose of sterilization.
Usage Medical Devices, Pharmaceutical Packages, Cosmetic Packages, Hygienic Goods, Food Packages, and Clean Room Related Materials Pharmaceutical Packages and Cosmetic Packages Medical Devices, Pharmaceutical Packages and Cosmetic Packages
Comparison with sterilization methods
Permeability Possible to sterilize under sealed package condition Not possible to sterilize under sealed package condition Not possible to sterilize under sealed package condition
Required property of material Radiation resistant material Poorly absorbed material None
Processing method Continuous method Batch method Batch method
Processing time Seconds to minutes 3 to 4 hours Ten-odd hours
Post processing Not required Not required Aeration
Confirming method of sterilization Radiation dosage Aseptic test Aseptic test
Validation Easy Easiest in the gas sterilization Many control items exist.

Electron Beam Sterilization

Irradiation works by electron accelerator (Dinamitron) with EB/X-ray. Since Taisei Kako has a lot of achievements in this field, this is a highly reliable sterilization.

Advantages of EB

On the quality
  1. 1. Not affected by temperature and pressure.
  2. 2. In comparison with gamma irradiation, less affected by quality degradation and change in color.
  3. 3. No possibility of residual materials such as gas.
  4. 4. Possible to sterilize in a completely sealed state.
  5. 5. Possible to sterilize in a final packaging state.
  6. 6. Easy to perform a sterilization validation
 
On the safety
  1. 1. No fear of gas toxicity in a working environment.
  2. 2. No use of radioactive substance.
  3. 3. The same principle of cathode ray tube for TV.
  4. 4. Possible to stop the operation instantly with turning off the switch,
 
On the cost
  1. 1. Due to short period of time for the radiation, the processing cost is low. Radiation time of EB is only a few seconds.
  2. 2. No need of facilities/space for a degasification.
  3. 3. Low running costs
  4. 4. No need to have gas permeability of packaging material.

2 facilities of EB Sterilization based in Japan.

2 facilities of EBS based in Japan.

Facilities of EB Sterilization

Taisei performs EB Sterilization service through both Tsukuba Center and Kansai Center of EBIS. Characters of our strengthen administrative controlling system on EB Sterilization facilities are described under:

  • By a cart conveyance system, the irradiation is able to cope with various kinds of shapes.
  • Firstly approved EB Sterilization facilities in Japan. Fully equipped Dynamitron that has a lot of actual achievements is used for the sterilization.
  • Dynamitron has 2 scan hornes for EB and X-ray. Since the switching is easy to perform, width of irradiation is enlarged.
  • In comparison with EOG, it is easy to cope with sterilization validation.
  • This quality control system is in accordance with ISO9002, ISO11137, EN46002 and EN552.
  • Since the locations are situated in the hub of transportation, it is easier to meet with a customer's request on the delivery date.

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Vaporized Hydrogen Peroxide Sterilization

VHPThis is a new service of sterilization by VHP facilities.
There are many advantages: This sterilization is possible to perform below room temperature. Quality degradation and change in color do not occur.


Advantages of VHP

On the quality
  1. 1. Quality degradation and change in color do not occur.
  2. 2. Since the sterilization is performed below room temperature (15-30℃), deformation of package does not occur.
  3. 3. Residual materials in a package are almost undetectable. Immediately after the sterilization, filling is possible.
 
On the safety
  1. 1. By using additional equipment of waste gas treatment, hydrogen peroxide is decomposed to water and oxygen, and discharged them.
  2. 2. Under reduced pressure, sterilization is performed, due to this, no leakage of sterilization gas.
  3. 3. Residual materials in the package are almost undetectable.
 
On the cost
  1. 1. Since control items are only a few, validation is easy to perform.
  2. 2. Since the sterilization is performed below room temperature, no need to set the preconditioning time.
  3. 3. Since residual materials in the package are almost undetectable, no need of degasification and cooling period.
  4. 4. Total required time for sterilization is less than 4 hours.

VHP滅菌装置の概略説明図

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Ethylen Oxide Gas Sterilization

Ethylen Oxide Gas SterilizationEOG sterilization is suitable for medical devices and pharmaceutical packages. Characters of our EOG sterilization are described under:


Advantages of EOG sterilization

On the hardware
  1. 1. Our sterilization facilities are made up of 3 sterilizers. (5m3, 8m3 and 10m3)
  2. 2. We cope with the sterilization through integrated process from preconditioning to completion of sterilization.
  3. 3. Humidification is performed by clean steam
  4. 4. Making uniform the gas concentration, temperature and humidity circulation system.
  5. 5. Fully equipped aeration room of 100u
  6. 6. Environment- friendly exhaust gas combustion equipment
 
On the software
  1. 1. Validation is fully performed in accordance with ISO system.
  2. 2. Well-developed measuring system such as microbial test, residual concentration test and strength test.

EOG滅菌装置の概略説明図

Please contact with us Tel:072-643-5791 Fax:072-640-2508 Taisei Kako Co., Ltd. Headquarter PC:567-0054 2-11-6,Fujinosato,Ibaraki city,Osaka pref お問い合わせ・資料請求