Regulation Information

The United States Pharmacopeia (USP) has recently published new guidelines for compounding practices and sterile preparations (USP <797>). State boards of pharmacy are likely to establish more specific and stringent requirements for sterile preparations, including parenteral, ophthalmic, and inhalation medications. This new chapter is effective June 1, 2008 and may be enforced by the Food and Drug Administration and by your state agencies.

Only MMI, Systems offers you three options for USP <797> compliance. Whether you prefer the efficiency of an open design or the physical barriers of a closed design, MMI can deliver a turnkey solution that’s perfect for your facility.

Open design

Open, doorless design for better workflow from zone to zone
Air filtration system with directional flow continually “washes” air
Meets all air flow displacement requirements in USP <797>

Closed design

Physical barriers between zones
Pass-through system with interlocks ensure that the system is closed at all times
Meets “positive pressure” requirements in USP <797>

797 Alliance

Most pharmacist are realizing that establishing a true clean room means more than just replacing an old hood - but rethinking the entire environment. MMI has an easy answer. The 797 Alliance offers a total turnkey solution to meeting and maintaining USP <797> compliance. From shelving to automation, from layouts to installation - we take care of everything.

Open or closed design
Designed to address future compliance issues
Electronic environmental monitoring for enhanced record keeping
Meets NIOSH requirements for chemo prep area

Let MMI show you a totally painless solution for total compliance. To find out more, call or email John Freels at MMI Systems today.