Sterilization Services

In order to give a customer “Safety”, Taisei adopts the most suitable sterilization for the product from 4 kinds of "Sterilization Methods".

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 4 kinds of "Sterilization Methods". Our attitude to the sterilization is to give safe quality to a customer by our high technology and updated facilities.
[Note] Since our sterilization service is performed along with our main business of manufacturing container for pharmaceuticals, only subcontracting business of steriolization is not acceptable.

Characteristics of our 4 kinds of "Sterilization Methods"

Our 4kinds of "Sterilization Methods"are under:	Electron Beam Sterilization	Gamma Rays Sterilization	Vaporized Hydrogen Peroxide Sterilization	Ethylene Oxide Gas Sterilization
Advantage	The shape of the sterilized product is not so much limited as other methods. In comparison with VHP or EOG, less affected by either temperature or pressure. In comparison with gamma irradiation, less affected by either quality degradation or discoloration. No possibility of residual gas. Easy to perform a sterilization validation.	Due to having its high permeability property, Gamma sterilization is usable to high density product. Almost no increase in temperatue. Due to less than the 2 times of the variation of dose, the affect of the dose to the material is less. Considering the affect of the dose to the plastic material is required. Easy to perform the sterilization validation. No residual of radioactivity / radiation.	No discoloration / strength deterioration Since the sterilization is performed at room temperature (15-30℃), deformation of package does not occur. Since the sterilization is performed below room temperature, no need to set the preconditioning time. Immediately after the sterilization, filling is possible. Since residual materials in the package are almost undetectable, neither the degasification nor the cooling period is required. Since control items are only a few, the validation is easy to perform.	The sterilization agent has high permeability. Our sterilization facilities are made up of 3 sterilizers. (5m³, 8m³ and 10m³) Well-developed measuring system such as microbial test, residual concentration test and strength test.
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 discoloration of COP. ・POM, Fluorocarbon resin and PP: Be cautious of strength deterioration of PP.	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 discoloration of COP. ・POM, Fluorocarbon resin and PP: Be cautious of strength deterioration of PP. ・Sterlizable for metal. Solution and rollled-state film	PE, PP, COP, SI, PTFE, Glass ・PA, Cellulose, PUR, ABS and PET are unsuitable because of easy-to-adsorb the sterilization agent.	Almost all materials are possible to sterilize.
Shape of product	The shape of the sterilized product is not so limited. Tightly sealed product is possible to sterilize Product of low bulk density is favorable.	The shape of the sterilized product is not so limited. Tightly sealed product is possible to sterilize Bulk density does not the matter. Sterilizable for complicated shape product, thick-wall mold product, and mixed products.	Simple shape of product is preferable	There is almost none of restriction on the shape of product.
Usage	Medical Devices Pharmaceutical Packages Cosmetic Packages Hygienic Goods Food Packages Clean Room Related Materials	Medical Devices Pharmaceutical Packages Cosmetic Packages Food Packages Equipment for Physical and chemical science	Pharmaceuticals Pharmaceutical Packages Cosmetic Packages	Pharmaceuticals Medical Devices Pharmaceutical Packages Cosmetic Packages
Sterilization Guideline	ISO 11137	ISO 11137	No Sterilization Guideline. Listed in the Reference Information of Ver 15 JP In accordance with EOG Guideline.	ISO 11135
Influence on the injection molding material	e.g. Under described influences were found on some grades of PP: ①Deterioration ②Discoloration ③Odour emission ④"Not Passed" on the test according to the "Notification No. 336 of the Pharmaceutical Affairs Bureau.	e.g. Under described influences were found on some grades of PP: ①Deterioration ②Discoloration ③Odour emission ④"Not Passed" on the test according to the "Notification No. 336 of the Pharmaceutical Affairs Bureau.	Plastic which has polarity property such as PET tends to adsorb gas easily. Since olefin plastics have low level of adsorption of gas, the influence on the drug is low.	There is adsorption to injection molding material.
Packaging	Possible to sterilize in the final sealed packaging. There is a thickness limitation of packing. No need to have gas permeability of packaging material.	Possible to sterilize in the final sealed packaging. Due to high transmission of the ray, restrictions of the packaging are not so many. No limitation of the thickness of the box If only the product is packaged in a tote box, the packaging form does not matter.	Sterilization bag with having the gas permeability is required.	Sterilization bag with having the gas permeability is required. Corrugated box is usable for the purpose of sterilization.
Influence on human body	None	None	Extremely low The decomposition products are water and oxygen.	Residual gas or by-product may affect the human health.
Process control	Just only to control easily on the radiation dosage.	Just only to control easily on the radiation dosage.	The most easiest method in the gas sterilization.	Many control items are required.
Releace	Possible to perform the dosimetric releace	Possible to perform the dosimetric releace	Difficult to perform the parametric release. After fonfirming the sterility by the sterility test.	Difficult to perform the parametric release. After fonfirming the sterility by the sterility test.
Processing time	Seconds to minutes	A few hours	3 to 4 hours	Ten-odd hours
Required period by the time you use	Immediately after the sterilization.	Immediately after the sterilization.	Immediately after the sterilization.	The curing period needs more than about 2 weeks.