Microbiological Contaminants

Certain formulations such as parenterals, ophthalmics, semi solids, oral solutions and topicals may require control of microorganisms prior to further processing.

In these instances, product contact surfaces should be evaluated for microbial contamination in conjunction with the overall cleaning validation program.

Sampling and enumeration methods used for environmental surfaces may be readily adapted for this purpose.

Microbial limits are established based on the route of administration and the nature of the product
itself (biocritical, hostile, etc.).

In addition to numeric limits, consideration should be given to
ensuring the absence of specific, objectionable organisms based on the nature of the product (S.aureus, E. coli, and Pseudomonas sp.)
For parenteral products, similar controls are necessary to limit the amount of endotoxins on product contact surfaces.
Control of microbial contamination for other dosage forms and processes may also be appropriate