Cooking could be troublesome. You would buy groceries, wash and prepare them at home, and then cook them. This is similar to the conventional operation method in the current market for injection vials. After purchasing glass packaging vials from the manufacturer, the pharmaceutical factory would go through their own cleaning and heat sterilization process. Then, after drying, they would fill the vials, seal them, and obtain the final product.

Then one day, you felt that cooking was too troublesome and wanted to buy ready-made meals. The vegetables were already washed and cooked, placed in a box, and all you had to do when you got home was open the lid and enjoy it with a glass of wine. This method is what we call wash-free and sterilization-free. The packaging company takes care of the cleaning and sterilization process of the vials all at once. After sterilization, the pharmaceutical factory can directly fill the vials.

So, what are the characteristics and requirements of wash-free and sterilization-free products? Today, let's discuss that.

The characteristics of wash-free and sterilization-free injection vials
These ready-to- use vials  are placed in plastic trays (similar to laboratory test tube racks, but designed to consider factors such as shaking during transportation). Then, the entire plastic tray is placed in a box, and the bottle openings are covered with a layer of DuPont Tyvek paper (to prevent the entry of particles during unpacking). Another layer of Tyvek paper is then laminated for sealing. In addition, there is an outer layer of double-layer breathable bag packaging as an additional sterile barrier.

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As an ISO standard specifically designed for wash-free and sterilization-free customization, its content, although concise, strives to be comprehensive, covering the requirements related to this type of product.

As mentioned earlier, the product undergoes four processes: cleaning, drying, packaging, and sterilization. During cleaning, the WFI (Water for Injection) needs to meet the requirements of the pharmacopoeia. During drying, the air needs to be filtered with a maximum pore size of 0.22 micrometers. The nest used for packaging needs to be agreed upon between the supplier and the pharmaceutical factory (Attachment F, Figure 5, which also mentions two ways of placing the bottle opening, either facing upward or downward). The sterilization level should achieve a SAL (Sterility Assurance Level) of 10^-6. Furthermore, the compatibility between the sterile barrier system and sterilization can be evaluated according to ISO 11607-1. The sterility testing can refer to EP 2.6.1, USP 71, and JP 4.06.



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From the perspective of pharmaceutical manufacturers, wash-free and sterilization-free products involve the introduction of particulate matter, bacterial endotoxins, and ethylene oxide. ISO 21882 provides a basic requirement presentation for such products. However, the specific requirements may vary slightly depending on the product in question, but these differences are generally minor.