The following is a compilation of US pharmacy consultants who specialize in issues related to USP Chapter <797> compliance.
Bio-Med QC, LLC
R. Douglas Haughs
CSP Sterility Control Consultant
6212 Stoner Dr, Suite B
Greenfield, IN 46140
Founded in 2006, Bio-Med QC, LLC, provides compounding sterility control through the advanced application of preventive microbiology, specifically designed for contamination prevention in pharmaceutical and sterile diagnostics manufacturing. Founder Doug Haughs has 40 years experience in contamination control and asepsis. He has extensive experience creating cleanroom environments and dedicated sterility control methods and procedures for pharmaceutical and sterile diagnostic manufacturers, and in 2006, he introduced the quantitative viable air sampling methods that are now published in USP <797>.
Bio-Med QC has developed microbiology systems for compounding pharmacy quality assurance programs that have been shown to increase the test sensitivity of the suggested USP media-fill test procedure through the application of appropriate microbiology and experimental design.
microbiology specialists inc
Alice Weissfeld, PhD, D(ABMM), F(AAM)
Paula Vance, RM/SM(NRM), SM(ASCP), CIE(IAQA)
8911 Interchange Dr
Houston, TX 77054
Alice Weissfeld, PhD, is the American Society for Microbiology delegate to the United States Pharmacopeia, and has been involved with formulation of the microbiology requirements for USP <797> from the beginning. Paula Vance, RM, SM, CIE, 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).
Alice and Paula are cofounders of microbiology specialists inc (msi), an accredited clinical and environmental microbiology laboratory. Accredited by CMS in bacteriology, mycobacteriology, mycology, parasitology, and virology, msi offers a range of laboratory and consulting services, including: 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.
Clinical IQ, LLC
Eric Kastango, MBA, RPh, FASHP
184 Columbia Tpke, Suite 4,
Florham Park, NJ 07932
Eric Kastango, MBA, RPh, FASHP, is the principal of Clinical IQ,LLC, an international health care consulting firm that assists clients who require expertise in sterile liquid and oral solid dosage form preparation, packaging, and distribution; USP Chapter <797> compliance; 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 hospital, community, and home care settings.
Eric is an active member and fellow of ASHP, served on the USP Sterile Compounding Committee from 2005-2010, and has been re-elected to the 2010-2015 USP Compounding Expert Committee. Eric has authored 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.
Performance Strategies, LLC
Kate Douglass, MS, RN, APN,C, CRNI
568 Cliff St
Ridgewood, NJ 07450
Performance Strategies, LLC, works to improve patient care and ensure desired patient outcomes by assisting clients in improving their sterile drug compounding and administration practices. Performance Strategies works with a wide range of clientele, including medical, nursing, and pharmacy groups in hospitals and alternate site settings. Performance Strategies designs approaches that help customers achieve desired work performance through a variety of educational and operational strategies.
Kate Douglass, principal of Performance Strategies, has supervised the design, engineering, and building of four pharmacy compounding complexes that meet or exceed USP <797> facility requirements. Additionally, Kate is a study co-director for the USP <797> Compliance Study, and is one of CriticalPoint’s expert authors. She has written numerous articles on sterile compounding and training.
LDT Health Solutions, Inc
Lou Diorio, RPh, Principal
Dave Thomas, RPh, MBA, Principal
38 Cedar Pl
Wayne, NJ 07470
LDT Health Solutions, Inc (LDT) is a medication safety and quality consulting firm with expertise in all areas of pharmacy practice, including regional compounding management, FDA compliance, regulatory affairs, and quality management.
LDT has over 25 years of expertise developing solid, easy-to-read policy and procedure manuals and the associated documentation that can be followed easily by all employees to enhance the level of service provided to patients.
LDT has unique expertise in automated compounding devices as well as the computer conductivity needed to maximize these devices within an organization, regardless of the geography or service model. Outsourcing/Contract Compounding and Regionalization
The provision of contracted compounding pharmacy services from offsite providers is a growing model in health care, as is the development of health system owned and operated models. LDT’s experience in developing, constructing, and managing successful, multistate compounding facilities under both Board of Pharmacy and cGMP regulations can help guide clients through the selection process for an organization, health system, or health network contemplating such a shift in medication delivery model.
Microbiology Research Associates, Inc
Fran McAteer, MS, MBA
33 Nagog Pk
Acton, MA 01720
Microbiology Research Associates, Inc, offers a full-service program for USP <797> compliance, including: cleanroom design and engineering; room certification; environmental monitoring; full microbiology laboratory service for USP <71> sterility tests, USP <85> bacterial endotoxin tests, and species IDs; on-site pharmacy staff media proficiency programs; cleanroom cleaning and sanitization services; 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.
Farrell Melnick, MS, PhD
Bernard D. Silverstein, MS, CIH, AIHAF
Batya van Messel, MS
329 Chestnut St
West Hempstead, NY 11552
Melnick Scientific president, Farrell Melnick, MS, PhD, founded the consulting firm in 2011 to combine the expertise of engineering and industrial hygiene with pharmacy USP <797> compliance. The firm consists of toxicologists, industrial hygienists, engineers, and pharmacists with expertise in USP <797> audits and compliance, including hazardous drug handling. The goal of Melnick Scientific is to use sound scientific principles to minimize contamination risk in hospitals and pharmacies. Working with Visante, a health care consulting firm, Melnick Scientific provides clients with complete service for all aspects of USP <797> compliance.
Farrell holds dual MS degrees in industrial hygiene and pharmaceutical chemistry, and a PhD in environmental engineering. He participated in the formulation of the USP <797> environmental testing requirements, and in the National Institute of Occupational Safety and Health (NIOSH) Hazardous Drug program. Senior industrial hygienist Bernard D. Silverstein, MS, CIH, AIHAF, is a certified industrial hygienist and American Industrial Hygiene Association (AIHA) Distinguished Fellow. He is a nationally recognized expert in exposure and risk assessment, a member of the AIHA Exposure Assessment Strategies Committee, and a past member of the NIOSH Occupational Research Agenda’s Exposure Methods Committee. Senior project manager Batya van Messel has an MS in hygiene from the University of Pittsburgh School of Public Health. She is a recognized expert in hazardous materials.
Controlled Environment Consulting
2527 King’s Mill Rd
Hellertown, PA 18055
Controlled Environment Consulting (CEC) provides specialized consulting services to the sterile compounding community. CEC president Jim Wagner’s experience as an active member of the cleanroom and containment industry since the late 1970s, combined with his appointments to the USP Sterile Compounding Committee responsible for Chapter <797>; the NSF/ANSI 49 Standard Steering Committee for Class II Biological Safety Cabinets; and the CETA CAG-002-2006 Isolator Applications Guide; provides CEC the expertise to guide clients in equipment selection for both hazardous and nonhazardous compounding.
CEC has worked with over 100 pharmacy and facility clients in choosing the best solutions and integration strategies for sterile compounding applications, and remains committed to bringing best practice applications to sterile compounding facilities.
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