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Terminal Sterilization of Sterile Pharmaceutical Preparations

Learn the process of terminal sterilization of the sterile pharmaceutical products by moist heat, irradiation and ethylene oxide.
Sterile pharmaceutical products, large volume parenterals and small volume parenterals are sterilized after the packing of the final products is known as terminal sterilization. Process is important to assure the sterility of the product.

Terminal SterilizerAll parenterals, ophthalmic products and medical devices are subjected to terminal sterilization. Products are sterilized terminally in batches as they are manufactured. These products are not thermally sterilized during the manufacturing but sterilized by filtration. It reduces the risk of non-sterile unit within the sterile product.

Hold time period should be validated before the terminal sterilization process starts. It is important to maintain the product quality because microbial growth may occur during the storage before the terminal sterilization that can harm the product quality.

Related: Low Temperature Sterilization Process (115°C)

There are following three methods of terminal sterilization:
1. Moist Heat Sterilization
2. Irradiation
3. Ethylene Oxide

Moist heat terminal sterilization is done by spraying hot water on the product units in the sterilizer. Steam is not used to sterilization because steam has high temperature that can cause thermal degradation of the drug. Terminal sterilization is not always done at 121°C for 15 minutes but it is changes as per the heat sensitivity of the product. But it is important to get desired F0 value by increasing the time of sterilization when we decrease the sterilization temperature. For example if we sterilize a heat sensitive product at 108°C, sterilization time should increase to 60 minutes. All large volume parenterals (LVP), small volume parenterals (SVP) and ophthalmic products are terminally sterilized by the moist heat method.
Irradiation and ethylene oxide are used for pre-filled syringes and other medical devices. Methods are also useful for the products those are highly heat sensitive.

Loading pattern of the product units for terminal sterilization should be uniform in the chamber for proper sterilization of all units. Heat should be distributed throughout the chamber and should penetrate the product.

Effect of terminal sterilization on product stability should be studied because it may degrade the product and may cause adverse effect to the user. A safe and effective combination of temperature and time should be selected for terminal sterilization for heat sensitive products.

Any of the method can be used for terminal sterilization according to the product to be sterilized but terminal sterilization process should be validated as it is an important part of sterile manufacturing.
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question

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