USP <797> Consultants

October 2010 : Cleanrooms & Compounding - Vol.7 No. 10 - Page #6

Clinical IQ, LLC
Eric S. Kastango, MBA,

184 Columbia Tpke, #282
Florham Park, NJ 07932

Clinical IQ, LLC is a consulting firm assisting clients who require expertise in the area of USP <797> and the implementation of extemporaneous compounding quality systems. Eric S. Kastango has dedicated his life’s work to patient safety through better pharmacy sterile compounding practices. He is an elected member of the USP Experts Committee for Sterile Compounding, providing him with unique insight into the philosophy and intention behind USP <797>.

Eric is an ASHP fellow and a highly regarded expert who frequently consults with clinicians and industry professionals. His articles on sterile compounding have been published in peer-reviewed journals, and he has authored textbook chapters on sterile compounding. As a sought after speaker and trainer, Eric’s passion for education is reflected in the online pharmacy training offered through his company, CriticalPoint (, and the STAR Center training classes he developed and led for Baxa Corporation.

Pharmfusion Consulting, LLC
Angela Turner Cassano, PharmD, BCPS
2110 Galloway Ter, Midlothian, VA 23113
804-517-5876  |

Pharmfusion Consulting, LLC strives to improve pharmacy operations and meet client goals through clinical expertise and attention to detail. Offering a wide range of consulting services, we work closely with clients to provide a customized solution that meets their needs. Sterile compounding is one of the most common areas in which we provide assistance.

USP <797> provides the framework to keep our patients safe, and doing the right thing takes time and resources. We are there to help you do it right and get it done on schedule. Whether you are in need of didactic or hands-on training, gap analyses, or customized policies and procedures, Pharmfusion is qualified to help.

Performance Strategies, LLC
Kate Douglass, MS, RN, APN, C, CRNI
568 Cliff St, Ridgewood, NJ 07450
201-251-4331  |

Performance Strategies, LLC provides a wide variety of services and deliverables to varied clientele, ranging from local startups to established national companies that cover diverse settings such as home care, home infusion, outsourcing, hospital and manufacturing. Using an Organizational Change Management approach, we assist health care organizations through the collection, documentation, analysis, design, implementation, and measurement of desired changes in key business sectors. This approach seeks to promote assimilation of desired changes at a minimum cost and cycle time.

Performance Strategies works primarily with pharmacy and nursing personnel focused on improving performance and patient outcomes through implementation of state-of-the-art sterile compounding practices, staff training, and competency assessment as well as quality management programs. Products and services include USP <797> gap analyses; onsite audits; policy, procedure, and form development; staff training programs; competency assessment formats; and integrated quality management programs.

LDT Health Solutions, Inc
Lou Diorio, RPh
Dave Thomas, RPh, MBA
38 Cedar Pl, Wayne, NJ 07470
862-221-9575  |

LDT is experienced in all areas of pharmacy practice, including regional compounding management, USP <797> compliance, regulatory affairs, and quality management. Our mission is to provide value through expertise and unsurpassed customer service. LDT has years of experience developing solid, easy-to-read policy and procedure manuals; these can be traditional “static manuals” or Web- or network-based references that can be followed by all employees.

Compounding Automation
We have unique expertise in automated compounding devices and the computer conductivity needed to maximize these devices regardless of geography or service model.

Outsourcing/Contract Compounding
Contracting compounding pharmacy services from off-site providers is a growing model in health care. Our experience in constructing, developing, and managing successful multi-state compounding facilities under both Board of Pharmacy and cGMP regulations can guide you through the selection process when shifting your medication delivery models.

Haddad-Wylie Industries (HWI Global)
3840 S Water St, Pittsburgh, PA 15203
412-884-3028 or 1-877-HWI-3028  |

In 2003, Haddad-Wylie Industries, (HWI Global) was formed with the intent of providing products with higher aseptic detail for the life sciences industry. HWI Global provides for all your USP <797> needs, including consulting, design, build-out, and maintenance services.

Through our nationwide consulting services, we can help you understand <797> in reference to pharmacy production load, room layout and work flow needs, necessary pharmacy upgrades, standard operating procedures, and more—all in a cost effective and efficient manner.

Power Enterprises
Luci A. Power, MS, RPh
90 Woodhaven Ct, San Francisco, CA 94131
415-742-5254  |

Luci A. Power is a lecturer and consultant on USP <797> and the NIOSH Alert: Preventing Occupational Exposures to Antineoplastics and Other Hazardous Drugs in Health Care Settings.

She has over 25 years experience in IV and hazardous drug systems with the University of California Medical Center in San Francisco (UCSF) where she served as manager of the inpatient IV service with responsibility for hazardous drug compounding. She designed, implemented, and managed a <797> compounding facility as part of the UCSF complex.

Luci is a primary author of the 1985 and 1990 ASHP Technical Assistance Bulletins on handling hazardous drugs and lead author of the 2006 ASHP hazardous drug guidelines. As an original member of the NIOSH working group on hazardous drugs, she is also an author of the 2004 NIOSH Alert on hazardous drugs., Inc
59 West 19th St, 6A, New York, NY 10011
212-463-0800  |  |, Inc is a privately owned company committed to public education and consulting on USP <797> regulation. provides consulting to pharmacy clients looking to upgrade or maintain their conformance to all of the latest <797> guidelines. Our consulting team comprises knowledgeable and experienced pharmaceutical industry professionals, all of whom have a significant sub-specialty in the area of <797> facility design, construction, certification, and operation.

microbiology specialists inc
Alice Weissfeld, PhD, D(ABMM), F(AAM)
Paula Vance, SM(NRCM), SM(ASCP), CIE

8911 Interchange Dr
Houston, Texas 77054

Dr. Alice Weissfeld is the American Society for Microbiology delegate to the United States Pharmacopeia (USP) and has been involved with formulation of the microbiology requirements for USP <797> from the beginning.

Ms. Paula Vance is a forensic microbiologist who can track organisms isolated in the pharmacy to their source (eg, the HVAC system, organisms brought in from outdoors or other areas in the hospital).

Dr. Weissfeld and Ms. Vance are co-founders of microbiology specialists inc (msi), an accredited clinical and environmental microbiology laboratory. msi offers a range of laboratory and consulting services. Accredited by CMS in bacteriology, mycobacteriology, mycology, parasitology, and virology, laboratory services include but are not limited to environmental monitoring of all ISO 5, 7, and 8 areas used for sterile compounding, sterility testing of batches, as well as randomly compounded sterile preparations, annual media fill, and gloved fingertip testing.

CSI Testing Inc
Carl LaBella, President
14020 23rd Ave North, Plymouth, MN 55447
763-383-9535  |  |

CSI Testing is a nationally recognized independent cleanroom and controlled environment testing service. Since 1975, our highly trained and experienced staff has provided critical environment validation, regular testing, and advisory services to cleanroom end-users nationally. As the largest service provider of this type in the Upper Midwest, CSI has the resources to evaluate a broad range of critical environments.

Controlled Environment Consulting
Jim Wagner
2527 King’s Mill Rd, Hellertown, PA 18055
610-428-0317  |

Controlled Environment Consulting (CEC) provides specialized consulting services to the sterile compounding community. The company president, Jim Wagner has been an active member of the cleanroom and containment industry since the late 70’s.

That experience, in combination with his 2005–2010 appointment to the USP sterile compounding committee responsible for chapter <797>, NSF/ANSI 49 standard steering committee for Class II Biological Safety Cabinets, and the CETA CAG-002-2006 Isolator Applications Guide allows Controlled Environment Consulting to confidently guide you through the difficult aspects of equipment selection for hazardous and non-hazardous compounding.

CEC has worked with over 80 pharmacy and facility staffs to pick the best solutions and integration strategies for their sterile compounding applications. We remain committed to bringing best practice applications to sterile compounding facilities.

Microbiology Research Associates, Inc
Fran McAteer

33 Nagog Park, Acton, MA 01720
978-263-2624  |

Microbiology Research Associates, Inc (MRA) offers a full service program for USP <797> compliance. Services provided include: cleanroom design and engineering; cleanroom certification; environmental monitoring; full microbiology laboratory service for USP <71> Sterility Tests and USP <85> Bacterial Endotoxin Tests; on-site pharmacy staff media proficiency programs; cleanroom cleaning and sanitization services; quality SOP’s; automated compounding devices validation; equipment calibration; USP <797> compliance audits for outsourced CSPs; robotic fill automation validation; stability testing; and personnel educational seminars.


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