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CleanRooms Magazine Recognizes June, 2004
Background: Pharmacy Compounding has exploded over the past five years and as a result compounding is receiving more regulatory attention from the Food and Drug Administration (FDA) and from some State Boards of Pharmacy. In response to this attention and the need to assure public health safety, the United States Pharmacopeia (USP) in early 2004 created Chapter 797 Compounding Pharmacy which defines "major requirements" of compounding pharmacies. Compliance with chapter 797 is not currently required by most states or the FDA. McGuff Compounding Pharmacy Services, Inc. is co-located with McGuff Pharmaceuticals, Inc. an FDA reviewed cGMP manufacturer of sterile injectable drugs. Both companies work together to assure the facility, personnel, quality systems and products meet all applicable requirements. CleanRooms magazine (monthly subscriber circulation 34,000) is the indispensable source of timely and enterprising news, comprehensive technical reports, authoritative insight, and recommended practices for professionals embracing contamination control technologies in the semiconductor, electronics, life sciences, pharmaceutical, food processing and aligned industries. CleanRooms Group, an integrated media franchise, is comprised of CleanRooms magazine, The Master Source Guide, several editorial supplements, a biweekly e-newsletter, www.cleanrooms.com, and six international conferences and tradeshows. The June 2004 CleanRooms magazine
published a column by Douglas Theobald, CFM entitled Here are some excerpts from Douglas Theobald's article: "Health care organizations that compound sterile formulations are getting a head start on compliance with the USP 797 guidelines, courtesy of the JCAHO (Joint Commission on Accreditation of Healthcare Organizations). One of the 19 elements slated to be surveyed is "environment design of drug preparation rooms." The critical elements we are going to focus on here are, room design, material/personnel flow, equipment layout, surface materials and serviceability... ...In the case of a sterile compounding environment, the goal is an aseptic or sterile environment in which you can control the risk of microbial contamination and cross-contamination of admixtures or compounds. Contamination can be found on surfaces as well as in the air, but what you are concerned about is beyond simple particulate contamination... ...A room that works The key to a controlled environment is control. This cannot be stressed enough in regards to every aspect of a sterile compounding room. The room itself should be well thought out in regards to material handling, personnel flow and equipment layout. Probably the most efficient quality system for the sterile compounding room is the "5 S" approach. In short this approach is to "Sort, Set, Shine, Standardize and Sustain." These elements are traditionally applied to a "lean manufacturing" facility, however it is very effective in environmental control. One of the best examples of a well designed and built cleanroom environment is at McGuff Pharmaceuticals (Santa Ana, Calif; www.mcguffpharmaceuticals.com). I recently had the opportunity to tour their facility, and it is nearly impeccable. Damon Jones, vice president and director of operations, says that McGuff chose to use two design consultants as well as an extensive design review and qualification before building their cleanroom. "One of the key elements," according to Damon, "was the placement of equipment to maximize process efficiency while minimizing possible turbulence in the airflow." To reduce the possibility of cross-contamination in the more critical environments, McGuff used the "single pass" method of providing conditioned air to the controlled environment(s). In this method, the air in the room is not re-circulated. Possible airborne contaminants, powders or compounds are exhausted from the room, and the air is replaced with fresh, conditioned and filtered air.." Summary We are proud of our facilities and staff at both McGuff Compounding Pharmacy and McGuff Pharmaceuticals. Both organizations undergo and pass numerous rigorous inspections by regulatory authorities and accrediting originations each year. Douglass Theobald, CFM and CleanRooms magazine have given us another chance to prove to you that we are doing our best to assure the safety of our patients through diligent quality control. We wish to express our thanks to Douglass for touring our facility and writing such kind words about us. For More Information Click here to read the complete article Click here for more information about CleanRooms magazine About the Author:
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