What is the difference between dedicated and non-dedicated equipment? : Pharmaceutical Guidelines

What is the difference between dedicated and non-dedicated equipment?

Interview Question #047
Dedicated equipment: It is used solely for the production of a single product or product line. Concerns over cross-contamination with other products are markedly reduced. Dedicated equipment must be clearly identified with the restrictions of use in order to prevent potential errors during cleaning and preparation.
Dedicated equipment is used only for a single product or products having the same active pharmaceutical ingredients.

Non-dedicated equipment: Where the same piece of equipment is utilized for a range of products formulations. The prevention of cross-contamination between products becomes the main objective in the cleaning validation effort. Clearly, cleaning non-dedicated equipment represents a more significant obstacle to overcome.
Non-dedicated equipment can be used or manufacturing and processing of any product that can have any active pharmaceutical ingredients.



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