Ethylene Oxide Aeration Room
Detailed explanation and analysis scheme of 4 analysis methods of ethylene oxide
Degassing/Aeration room can quickly remove some EO residues from the product.
There are usually four ways of aeration:
Option A：Aeration in the separate Aeration room for 1-2 days. Generally, Syringes, long catheters, gloves require separate Degassing/Aeration room.
Option B：Aeration in the same sterilization chamber. At this point, due to the products to be sterilized being in the sterilizer for 24 hours or longer, it is necessary to expand the capacity of the sterilizer to load more products.
Option C：a dedicated parsing cabinet, which meets the release standard within one day of parsing. Short cycle costs are higher.
Option D：If option A, B, C is not selected, sterilized products can be placed in a well ventilated warehouse and naturally aerated for 14-20 days. In this case, there is a risk of EO residue not meeting the standard.
Additionally, what is the requirement for EO residue of sterilized products in ppm? 10ppm? or other?
Generally, standard requires the EO residue of products after EO sterilization shall not exceed 10ppm (10μg/g) when leaving the factory.
Finally, the duration of Degassing/Aeration and EO residue depends on PQ.
It is usually recommended to use option A or B to allow for the removal of gaseous residues down to a legally acceptable level.
Examples of ethylene oxide analysis
Take an example of a 6 cubic sterilizer. The price of 6 cubic sterilizer is $33,000, and the area is 7 * 7 = 50 square meters.
1. Use natural analysis, analysis takes about 14 days, the storage area needs to reserve about 80 square meters.
2. Select the analysis room, analysis period: 3-5 days, the analysis room volume is 33 cubic meters, the cost is about $18,000, and the total equipment price of the sterilizer and analysis room is about $50,000.
3. Select the parsing cabinet, and the parsing standard will be achieved within one day without parsing. The cost of the parsing cabinet is about $70,000. Features: short cycle and high cost. The total equipment price is around $60,000.
4. Sterilizer + upgrade compulsory analysis function. After 1 day of compulsory analysis, leave it in the warehouse for about 3 days. If the sterilizer has a forced analysis function, there is generally no need for an analysis room. At this time, an upgraded version of 11 cubic meters of sterilizer needs to be selected, and the cost is about $45,000.
Ethylene oxide analysis scheme selection summary
In summary, if the warehouse area is limited, use an upgraded version of the sterilizer or analysis room; if the budget is sufficient and the analysis cycle requirements are high, it is recommended to use an analysis cabinet for analysis;
If the area of the warehouse is large, you can directly store it in the warehouse for about 14 days, but natural analysis is not suitable for medical supplies with strong sealing, there is a risk of EO residue not meeting the standard.
Jun 17, 2025
view: 1001
6 cube ethylene oxide sterilizer 1. The ethylene oxide sterilizer can be installed in the non dust-free workshop. How large area and workshop height should be reserved for the 6 cubic sterilizer? The height of the workshop shall not be less than 3m,...
Read More
Jun 17, 2025
view: 1110
Storage of ethylene oxide 1 ethylene oxide shall be stored in a separate room. The room shall be equipped with ventilation, explosion-proof and fire-fighting facilities. 2 the ethylene oxide cylinder shall be stored in a cool place away fro...
Read More
