USP Chapter <797> Consultants


May 2014 - Vol. 11 No. 5 - Page #22

LDT Health Solutions, Inc
Lou Diorio, RPh & David Thomas, RPh, MBA
38 Cedar Pl
Wayne, NJ 07470
862-221- 9575
LSDiorio@LDTRx.com
www.ldthealthsolutions.com

LDT Health Solutions, Inc (LDT), is a medication safety and quality management consulting firm providing its expertise to all areas of pharmacy practice including health system compounding centralizations, USP <797> compliance, regulatory affairs, and 503-B facility management.

Quality Management
LDT has over 30 years of expertise in 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 to enhance the level of service provided to patients.

Compounding Automation
LDT has unique expertise in automated compounding devices and the computer conductivity to maximize these devices within your organization, regardless of the geography, service model, or bar coding requirements.

Outsourcing—Contract Compounding
With the advent of the Drug Quality and Security Act (DQSA), the provision of contracted pharmacy services from providers is a more complex model. LDT can bring our experience in facility design, program development, and formulary management of successful multi-state compounding facilities under these new federal regulations to guide you through the selection or development process if your organization, health system, or network is contemplating such a shift in medication delivery model.


Cleanroom Construction Associates
Tim Loughran
14319 Kenmont Dr
Midlothian, VA 23113
Scott Mackler
2123 Edgestone Rd
Dallas, TX 75230
804-678-9888
TimL@cleanroom-construction.net
www.cleanroom-construction.net

Tim Loughran and Scott Mackler collectively have more than 50 years of experience designing and constructing cleanrooms for sterile compounding facilities. Their expertise entails a complete understanding of USP <797>, how it is interpreted and applied for non-hazardous drugs, hazardous drugs, and radiopharmaceuticals, and the compliance required for construction of these facilities, including the interpretation of cGMP facility requirements to ensure compliance with all potential interpretations and compliance assessments. Cleanroom Construction Associates can support clients’ needs executing user requirement specifications; basis of design documents; concept designs; design reviews; compliance assessment; contracting methods; requests for proposal; technical review of proposals for compliance, budgeting, scheduling; and construction QA/QC.


Clinical IQ, LLC CriticalPoint, LLC
Eric Kastango, MBA, RPh, FASHP
184 Columbia Tpke, Suite 4
Florham Park, NJ 07932
973-765-9393
www.clinicaliq.com

12154 Darnestown Rd, Suite 360
Gaithersburg, MD 20878
240-238-4352
moreinfo@criticalpoint.info
www.criticalpoint.info

Eric Kastango, MBA, RPh, FASHP, is the founder and president of Clinical IQ, LLC, a consulting firm located in Florham Park, New Jersey, and CriticalPoint, LLC, a Web-based health care education company located in Gaithersburg, Maryland. Eric is a Fellow of ASHP and he served as an elected member of the USP Expert Committee for Sterile Compounding for the 2005-2010 cycle, providing him with unique insight into the philosophy and intention behind USP Chapter <797>. Eric was re-elected to serve on the Compounding Expert Committee (CEC) for the 2010-2015 cycle but stepped down in April 2013 to support the educational efforts of the NABP and individual state boards of pharmacy to master and accurately inspect for compliance with USP Chapter <797>.

Clinical IQ, LLC, is an internationally recognized health care consulting firm that assists clients who require expertise in sterile form preparation, packaging, distribution; USP Chapter <797> compliance; cGMP and the new DQSA law; and the implementation of process control and quality management systems. CriticalPoint is a health care publishing company that provides more than 40 Web-based educational courses, all ACPE-approved for CE education for pharmacists and technicians in the fields of sterile compounding. CriticalPoint also delivers a variety of live training including the Sterile Compounding Boot Camp.


Bio-Med QC, LLC
R. Douglas Haughs
CSP Sterility Control Consultant
PO Box 39259
Indianapolis, IN 46239
317-357-5000
doug@biomedqc.com
www.biomedqc.com

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.


Technical Safety Services, Inc
Andrew King
620 Hearst Ave
Berkeley, CA 94710
(Tel) 800-877-7742
info@techsafety.com
www.techsafety.com

Technical Safety Services (TSS) is the largest cleanroom testing and certification company in North America. Andrew King, credentialed as a registered cleanroom certification professional in sterile compounding (RCCP-SC) through CETA, leads the TSS training program for testing and certification at sterile compounding facilities. TSS has developed a systematic approach to help hospital pharmacies achieve regulatory compliance. Following a comprehensive gap analysis, TSS will provide CETA certified technicians to conduct all necessary testing and certification. TSS also offers training programs designed to provide pharmacists and support personnel with a better understanding of USP <797> and best practices for maintaining compliance.

TSS understands that delivering safe, effective medication to patients is more than just a good idea—it is an obligation. For more detailed information about our USP <797> compliance services or to find out if you qualify for a complimentary USP <797> gap analysis, contact Andrew King or your local TSS representative today.


Controlled Environment Consulting
James Wagner
2527 King’s Mill Rd
Hellertown, PA 18055
610-428-0317
jimwagner@cenvironment.com

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 1970s. 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 CEC to confidently guide you through the difficult aspects of equipment selection for both hazardous and nonhazardous compounding.

CEC has worked with over 100 pharmacy and facility leaders to pick the best solutions and integration strategies for their sterile compounding applications, and remains committed to bringing best practice applications to sterile compounding facilities.


Microbiology Research Associates, Inc
Fran McAteer, MS, MBA
33 Nagog Park
Acton, MA 01720
978-263-2624
mra.ma@rcn.com
www.mra-bact.com

Fran McAteer, MS, MBA, is vice president of Microbiology Research Associates, Inc (MRA), an FDA-registered consulting and testing laboratory specializing in USP <797> compliance. Fran has expertise in sterile compounding, cleanroom engineering, environmental monitoring, cleaning, disinfecting, and contamination control. He also has experience in implementing USP <797> quality programs for hospital pharmacies, including IV, oncology, OR, allergy and nuclear pharmacies, and compounding laboratories. Fran has technical expertise in GMP processing, high risk USP <797> compounding, rapid sterility methods, BUD extension, sterilization validation, process simulation, cleaning verification, airflow pattern testing, anticipatory compounding, FDA audits, and FDA remediation reports.

MRA offers a full service consulting program for USP <797> compliance, including: Cleanroom design and engineering; ISO 14644 certification; environmental monitoring program implementation; full pharmaceutical microbiology laboratory service for USP <71> sterility tests, USP <85> bacterial endotoxin tests, and species IDs; administering pharmacy staff media proficiency programs; quality SOP’s; automated compounding device validation; equipment calibration; USP <797> compliance assessment reports for high risk CSPs; robotic fill automation validation; stability testing; depyrogenation; cleaning validations; and staff USP <797> educational seminars. Fran is an active member of the International Academy of Compounding Pharmacists (IACP), Controlled Environment Testing Association (CETA), Parenteral Drug Association (PDA) and the International Society for Pharmaceutical Engineering (ISPE).

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