Facility Design for Pharmacy Operation. Full-Scale Nuclear. Slides are not to be reproduced without permission of author.

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1 Facility Design for Pharmacy Operation Full-Scale Nuclear in a Hospital Setting Neil A. Petry, MS, RPh, BCNP, FAPhA Clinical i l Assistant t Professor in Radiology Director, Radiopharmacy Services Duke University Medical Center petry005@m mc.duke.edu edu USP General Chapter <797> Workshop Session 2009 Annual Meeting Society of Nuclear Medicine June 13, 2009 Toronto, Canada

2 USP Chapter <797> - A Standards in the chapter are intended to apply to all places where CSPs are prepared» Hospitals and other healthcare institutions» Patient treatment clinics» Pharmacies and nuclear pharmacies» Physicians practice facilities Applicability to Facilities» Other locations and facilities in which CSPs are prepared, stored and transported Nuclear medicine hot labs and clinical areas

3 Significance ifi of Sterile Compounding Facilities Optimally designed and functioning facilities provide:» Highly controlled particle free work environments» Means to effectively and efficiently remove personnel and process generated particles / contaminates» Free and comfortable movement pathways to facilitate a variety of aseptic processing support tasks» Means to limit it potential ti negative impact of critical site touch contamination following the necessary touching of sanitized but nonsterile packages, PEC surfaces, equipment, other objects during aseptic processes

4 USP Chapter <797> - F Facility Design Shalls (1) Physically designed and environmentally controlled to minimize airborne contamination from contacting critical sites Shall provide a comfortable and well-lighted working environment, which typically includes a temperature of 20 C or cooler to maintain comfortable conditions for compounding personnel when attired in required aseptic compounding garb PECs provide unidirectional (i.e., laminar) HEPA air at a velocity sufficient to prevent airborne particles from contacting critical sites Clean rooms for nonhazardou s and nonradioactive CSPs are supplied with HEPA air that enters from ceilings with return vents low on walls, and provide not < 30 air changes per hour Appendix I, USP Chapter <797>, December 2007

5 USP Chapter <797> - F Facility Design Shalls (2) Buffer areas maintain 0.02 to 0.05 inch water column positive pressure, and do not contain sinks or drains Air velocity from buffer rooms or zones to ante-areas is at least 40 feet per minute PECs placed within a buffer area in such a manner as to avoid conditions that could adversel y affect their operation PECs placed out of the traffic flow and in a manner to avoid disruption from the HVAC system and room cross-drafts HEPA-filtered supply air introduced at the ceiling Activities / tasks carried out within buffer area limited to only those necessary when working within a controlled environment Appendix I, USP Chapter <797>, December 2007

6 USP Chapter <797> - F Facility Design Shalls (3) Only furniture, equipment, supplies, and other material required for compounding activities to be performed brought into room Surfaces and essential furniture in buffer rooms or zones and clean rooms shall be nonporous, smooth, non-shedding, impermeable, cleanable, and resistant to disinfectants Surfaces of ceilings, walls, floors, fixtures, shelving, counters, and cabinets in buffer area shall be smooth, impervious, free from cracks and crevices, and non-shedding, thereby promoting cleanability and minimizing spaces in which microorganisms and other contaminants may accumulate Surfaces shall be resistant to damage by disinfectant agents Appendix I, USP Chapter <797>, December 2007

7 USP Chapter <797> - F Facility Design Shalls (4) Junctures of ceilings to walls coved or caulked to avoid cracks and crevices where dirt can accumulate Ceiling tiles caulked around ea ach perimeter to seal them to the support frame Exterior lens surface of ceiling lighting fixtures smooth, mounted flush, and sealed Any other penetrations through the ceiling or walls sealed Buffer area contains no sources of water (sinks) or floor drains Buffer area work surfaces constructed of smooth, impervious materials, such as stainless steel or molded plastic, so that they are easily cleaned and di isinfected Appendix I, USP Chapter <797>, December 2007

8 USP Chapter <797> - F Facility Design Shalls (5) Carts shall be of stainless steel wire, nonporous plastic, or sheet metal construction with good quality, cleanable casters to promote mobility Storage shelving, counters, and cabinets shall be smooth, impervious, free from cracks and crevices, nonshedding, cleanable, and disinfectable Their number, design, and manner of installation the items above shall promote effective cleaning and disinfection Appendix I, USP Chapter <797>, December 2007

9 USP Chapter <797> - F Facility Design Shoulds If ceilings consist of inlaid panels, the panels should be impregnated with a polymer to render them impervious and hydropho bic Dust-collecting overhangs, such as ceiling utility pipes, or ledges, such as windowsills, should be avoided Air returns should be mounted low on the wall creating a general top-down dilution of room air with HEPA-filtered make-up air Appendix I, USP Chapter <797>, December 2007

10 Nuclear Pharmacy Sterile Compounding Facilities Should be designed to provide adequate space for the work load anticipated and for future expansion Expansion space should be provided and, as the service demands and compounding volume increases, the ability to maintain environmental and process controls must not be compromised by overcrowd ding Must be designed with due consideration of scope of operation and the microbial risk-levels associated with the compounding services to be provided ALARA mandated radiation shielding and safety must be accommodated

11 Conceptual Representation Required Nuclear Pharmacy Facility USP Chapter <797>, December 2007

12 Radiopharmacy Duke University Medical Center Radiopharmacy acy Floor Plan Generator Hood

13 Radiopharmacy Duke University Medical Center Ante Area/Staff Work/In Vitro/Hall to support area/cl ean room entry y

14 Radiopharmacy Duke University Medical Center Clean lab entry/low- y Risk/Generator/Cell /C Labeling/High-Risk

15 High Risk/Radioiodine/QC Are eas Radiopharmacy Duke University Medical Center

16 Support Areas Radiopharmacy Duke University Medical Center

17 Radiopharmacy Duke University Medical Center Cleaning - Disinfection y

18 Radiopharmacy Duke University Medical Center Radioactive Storage y

19 Ship/Receive Radiopharmacy Duke University Medical Center

20 Radiopharmacy Duke University Medical Center Radiopharmacy acy Floor Plan Generator Hood

21 Thank You