USP <797> Consultants

October 2011 : Cleanrooms & Compounding - Vol.8 No. 10 - Page #24

The following is a list of pharmacy consultants from across the United States who specialize in USP Chapter <797>-related issues. 

Clinical IQ, LLC 
Eric S. Kastango, MBA, RPh, FASHP
184 Columbia Turnpike, Suite 4, Florham Park, NJ 07932 
(973) 765-9393  |  |

Eric S. Kastango, MBA, RPh, FASHP, is the principal of Clinical IQ, LLC, an international health care consulting firm that assists clients who require expertise in the area of sterile liquid and oral solid dosage form preparation, packaging and distribution, USP Chapter <797>, pharmacy- and pharmaceutical-based aseptic processing, medical device manufacturing, and the implementation of process control and quality management systems. Since 1980, he has practiced pharmacy in a number of practice settings, including hospitals, community, and home care.

Eric, an active member and fellow of ASHP, has served on the USP Sterile Compounding Committee from 2005-2010 and was recently re-elected to the 2010-2015 USP Council of Experts, Compounding Expert Committee. Eric has given over 150 invited national and international professional presentations on a variety of pharmacy practice topics, including sterile product preparation, pharmacy compounding errors, process improvement, and quality management systems. 






















LDT Health Solutions, Inc
Lou Diorio, RPh, David Thomas, RPh, MBA
38 Cedar Place, Wayne, NJ 07470
(862) 221-9575  |  |

LDT Health Solutions, Inc. (LDT) is a healthcare consulting firm with expertise in all areas of pharmacy practice, including regional compounding management, compliance, regulatory affairs, and quality management.

Quality Management: LDT has over 20 years of expertise in developing solid, easy to read, policy and procedure manuals that can be followed by all employees to enhance the level of service provided to your patients. 

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

Outsourcing and Contract Compounding: Contracting outsourced compounding services is a growing model in health care. LDT brings experience in construction, development, and management of multi-state compounding facilities under both Board of Pharmacy and cGMP regulation to guide you through the selection process if your organization is contemplating such a shift in your medication delivery model.

E. Clyde Buchanan, LLC 
Clyde Buchanan, MS, RPh, FASHP
1410 Brawley Circle NE, 
Atlanta, GA 30319  |  770-458-0304  |

Clyde Buchanan, MS, RPh, FASHP, is a pharmacy consultant and expert on compounding sterile preparations and pharmacy planning, budgeting and operations. With 28 years of experience as a hospital pharmacy director, he has the expertise to help pharmacists in meeting sterile compounding standards. E. Clyde Buchanan, LLC’s mission is to improve the safety of sterile compounding by using the best standards, the most practical procedures, and the most cost-effective facilities, equipment and supplies for your facilities needs.

Mr. Buchanan provides his assistance to help hospitals conduct gap analyses of sterile compounding operations, build strategic master facility plans, and develop functional floor plans. He works with pharmacy organizations to put together training presentations on sterile compounding for organization members, as well as pharmacy department strategic planning and budgeting. In addition, Mr. Buchanan can aid hospital pharmacy requests for proposals and proposal reviews for cleanroom vendors, architects, hood and isolator vendors, training programs, environmental monitoring companies, and procedures.


Microbiology Research Associates, Inc
Fran McAteer
33 Nagog Park, Acton, MA 01720
(978) 263 2624  |  |

Microbiology Research Associates, Inc offers full service USP <797>-compliance programs that include: cleanroom design and engineering, certification, environmental monitoring, full microbiology laboratory service for USP <71> Sterility Tests, USP <85> Bacterial Endotoxin Tests, and Species IDs. Additional services include on-site pharmacy staff media proficiency programs, cleanroom cleaning and sanitization, quality SOPs, automated compounding device validation, equipment calibration, USP <797> compliance audits for outsourced CSPs, robotic fill automation validation, stability testing, and personnel educational seminars.

microbiology specialists inc 
Alice Weissfeld, PhD, D(ABMM), F(AAM), Paula Vance, SM(NRCM), SM(ASCP), CIE
8911 Interchange Drive, Houston, Texas  77054
(713) 663-6888  |  |

Dr. Alice Weissfeld is the American Society for Microbiology delegate to the 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 tracks organisms isolated in the pharmacy to their source. 

Dr. Weissfeld and Ms. Vance are co-founders of microbiology specialists inc (msi), an accredited clinical and environmental microbiology laboratory that offers a range of services. Accredited by CMS in bacteriology, mycobacteriology, mycology, parasitology, and virology, msi’s services include environmental monitoring of all ISO 5, 7 and 8 areas used for sterile compounding; sterility testing of batches as well as compounded sterile preparations; annual media fill; and gloved fingertip testing.






















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


Performance Strategies, LLC assists customers in improving sterile drug compounding and administration practices by working with a range of clientele, including medical, nursing, and pharmacy communities in hospitals and alternate-site settings. Kate Douglass, president of Performance Strategies, is a co-author of CriticalPoint’s USP <797> Gap Analysis Tool and co-director of the 2011 USP <797> Compliance Study. Kate has been a module author for CriticalPoint’s sterile compounding Web-based training and has written several articles on sterile compounding quality and training. 


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