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In addition to the USP quality standards for ointments, ophthalmic ointments must also meet quality standards for sterility and absence of metal particles. Which of the following methods of sterilization are used for ophthalmic ointments? there are no good terminal sterilization methods for ophthalmic ointments, so the components are sterilized separately and then processed together aseptically, preservatives are added when called for ophthalmic ointments are sterilized by filtration opthalmic ointments are sterilized by dry heat sterilization in a depyrogenation oven ophthalmic ointments are sterilized by autoclaving

Question

In addition to the USP quality standards for ointments, ophthalmic ointments must also meet quality standards for sterility and absence of metal particles. Which of the following methods of sterilization are used for ophthalmic ointments?

there are no good terminal sterilization methods for ophthalmic ointments, so the components are sterilized separately and then processed together aseptically, preservatives are added when called for

ophthalmic ointments are sterilized by filtration

opthalmic ointments are sterilized by dry heat sterilization in a depyrogenation oven

ophthalmic ointments are sterilized by autoclaving

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Solution

The correct method of sterilization for ophthalmic ointments is that there are no good terminal sterilization methods for ophthalmic ointments, so the components are sterilized separately and then processed together aseptically, preservatives are added when called for.

This is because ophthalmic ointments are sensitive to heat and pressure, which makes methods like dry heat sterilization in a depyrogenation oven and autoclaving unsuitable. Filtration is also not a suitable method as it may not remove all contaminants. Therefore, the components of the ointment are sterilized separately and then combined in a sterile environment to ensure the final product is free from contaminants.

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