scope:

These sanitary/hygienic standards provide minimum materials and surface property requirements, including minimum fabrication related materials and surface property requirements for equipment and components utilized in the pharmaceutical manufacturing environment whereby those material and surface properties may directly, indirectly, or incidentally impact the strength, identity, safety, purity or quality of the active pharmaceutical ingredient, excipient, or drug product.

Subject materials include metals, non-metals (i.e. polymerics, plastics, elastomers, ceramics, glass, lubricants, sealants, and adhesives), and their processed forms intended for single or multiple-use as direct, indirect, or incidental product contact and/or cleaning solution (aqueous and/or nonaqueous) contact surfaces in equipment for production, processing, and handling of the active pharmaceutical ingredient, excipient, or drug product.

This standard shall apply to new equipment.

See Appendix A for those manufacturing steps for which this standard intended to apply.