Non-Sterile -Sterile

The Production of sterile formulations increases the extent of cleaning operations relative to non-sterile products. Sterile manufacturing facilities must control microbial, endotoxin and particulate levels to a degree not common with non-sterile products.

Not only are the number of concerns increased but the nature of these contaminants makes the successful removal of
these items (and their validation) more difficult.

Sampling methods for these contaminant are more subjective, the analytical methods more demanding, and the validation generally
more difficult to complete.

Concerns relative to microbial and particulate control are lessened in the production of nonsterile products but are still important.

Practices which minimize the potential for contamination by "objectionable organisms" are common in the manufacture of non-sterile formulations such as oral liquids and topical products.