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.
No comments:
Post a Comment