Virtual Healthcare Tradeshow:
USP <797> Compliance

Quality • Integrity • Innovation

J57TPN AUTOMATIC REFRACTOMETER

The J57TPN is intended for use in hospital pharmacies to monitor the quality of parenteral nutrition mixtures and ensure compliance with USP<797>. It is also useful in preventing the diversion of narcotics and other controlled materials. The J57TPN provides a fast, easy to use way to check on materials returned from the operation theater or incorrectly issued from the pharmacy.

Application

The first decade of the 21st Century has seen dramatic changes in health system pharmacies. New regulations such as USP<797> are forcing compounding pharmacies to do quality checks that were previously only required of pharmaceutical manufacturers. The J57TPN from Rudolph Research Analytical is designed to comply with this new regulatory environment.
Drug Diversion Monitoring

The J57TPN also doubles as a refractometer to monitor potential drug diversion issues. Ever more strict laws mean a health system must be aware of what is happening with controlled substances. Measuring operating theater returns and similar movements of controlled substances can be a key part of an organization's policy on meeting these laws.
Automatic Measuring System

The J57TPN features a fully automatic measuring system. The operator simply places the sample on the prism, presses a button and the result is displayed on a 7.5cm x 10cm backlit LCD. There are no shadow lines to match and there is no eyepiece requiring operator determination or manual adjustment.

Pharmacy Relevant Calculations

The J57TPN has built-in comparison and calculations. The user enters the % Dextrose and % Amino Acid and the instrument displays both the calculated and measured result, making it easy for an operator to see if the material is within specification.
Electronic Temperature Control

Refractive Index is a temperature sensitive property. For many years pharmacies largely ignored this fact or used sugar based temperature correction. Pharmaceutical manufacturers who were constrained by USP guidelines were not able to ignore this as USP<831> clearly states that they had to measure at a controlled temperature, generally 20°C. Now that pharmacies are under similar pressure, temperature sensitivity also must be considered. Fortunately with the J57TPN, old style circulating baths are a thing of the past and sucrose based mathematical approximations are not needed because of the instrument's built in electronic heating and cooling which ensures the sample is measured at 20°C every time.

No matter what the application, Rudolph's complete line of polarimeters, saccharimeters, refractometers and accessories can meet your laboratory's needs for accuracy, reliability and performance.

Rudolph Research Analytical manufactures high precision refractometers for research laboratory and QC applications. Our J Series product line includes standard and wide range units, including the J57, J157, J257 and J357 refractometers. Electronic temperature control is standard on all of our refractometers, eliminating the need for waterbaths-resulting in cost savings and avoidance of possible contamination. Learn how Rudolph Research Analytical J Series refractometers differ from the traditional Abbe refractometer, by eliminating the need for prism replacement.

LDT Health Solutions, Inc. is a total quality management firm, specializing in Controlled process and quality management strategies for the pharmacy community.

LDT has over three decades of experience in extemporaneous Pharmacy compounding, cGMP manufacturing, Homecare product preparation, and Hospital clean room applications. LDT is a leader in regulatory affairs and compliance, and can offer its expertise to assist your organization in bring forth the highest quality preparations and services possible.

We have technical expertise in automated compounding devices, software, and custom compounding methodologies. Through our use of “point of failure” analysis we can develop unique solutions for your practice setting and particular application, enlisting a blend of technical, automation, software and controlled process thinking.

Please visit us today at www.ldthealthsolutions.com to see how LTD can partner with you to make your practice all it can be.

For more information about LDT Health Solutions, Inc. or to contact us, use the link provided below.

Since 1982, Rees Scientific has set the industry standard for environmental monitoring, access control and automated watering. Today, we continue to lead the field, taking cues from our clients and their environmental challenges. From unwavering temperature monitoring in refrigeration, freezing and incubation, to lighting, humidity and automated watering for animal laboratories, Rees Scientific provides automated environmental monitoring and access control technologies to a limitless number of applications in a wide range of industries.

Our fully validated systems are Windows based, 21 CFR 11 compliant. Automated daily printouts, alarm notification, audit trails and complete data encryption are just a few of the standard features that help you meet your FDA, GMP, GLP, USDA, AABB, AAALAC, CAP, JCAHO or other regulatory requirements. From Pharmaceutical to Blood Banking, Laboratory Animal Research to Biotech and Hospitals, Rees Scientific has become the standard by which other monitoring systems are judged.

Centron EMS

A single Centron EMS (Environmental Monitoring System) can monitor a diverse facility with multiple locations while it provides instant data access and sophisticated analysis right from your desktop computer. Our continually expanding line of monitors is matched only by our around-the-clock service and support team. Always expandable, dividable and network compatible, Rees systems provide you with alarm notification, programming flexibility, rich documentation and a host of other features. Rees systems are used by virtually every major pharmaceutical company worldwide and the Centron has become the industry’s standard in blood banks and similar facilities.

Our full turnkey installation goes well beyond hardware and software. Rees provides complete installation including system validation, sensor calibration and thorough training of your personnel, as well as service and warranties on all parts and labor.

• Compliance - Meet today’s toughest standards with total support documentation – designed to meet FDA, GLP, GMP, AABB, AAALAC, USDA and other regulatory requirements.
• Protection - Safeguard valuable research, effort and product.
• Cost Control - Reduce losses and limit your exposure to risk.
• Time Preservation - Save energy and resources with streamlined, automated data collection.
• Integrated Access Control - Total security for individual rooms, corridors or entire facility.
• Centralized Alarm Systems - From local sonic to voice telephoned to e-mail alarm capabilities, day and night.
• Centralized Data Collection - Reducing the costs and time associated with chart or manual recordings while increasing accuracy.
• Validation - On-site hardware and software validation, including calibration, probe verification and user training. 1000+ page validation test reports.
• Networking - Operates over existing LAN/WAN network utilizing TCP/IP. Multi-user, multi-building, multi-site capability.
• Support for Oracle and SQL Server Database Engines – Industry standard data formats and greatly increased security and reliability. Individual users have no direct access to system files.
• Advanced and Custom Report Generation – A vast new array of analysis reports are now available built-in to the Centron system and can be easily accessed from any workstation. Generate reports based on time, date, activity, input, event type or multiple criteria. Select only events with Comments, only “Nobody Home” events, only events with an open investigation pending, only events pertaining to a specific input, system wide events pertaining to maintenance issues, etc.

Analytical Research Laboratories (ARL), a division of ARL Biopharma, has been serving the pharmaceutical and health-related industries since 1994. With over 50 years of combined experience in the industry, ARL can meet and exceed your analytical needs. We offer a full range of professional laboratory services, both analytical and microbiological, as well as consulting services, research and development and forensic legal support. ARL’s professional staff can respond to even the most unusual requests. We use state-of-the-art instrumentation, and provide rapid turnaround time and personal service. Contact us for additional information or a detailed quote.

Laboratory Services
Analytical Research Laboratories (ARL) offers complete analytical services utilizing state-of-the-art instrumentation, including Gas Chromatography (GC), Liquid Chromatography (LC) and Mass Spectrometry (MS). ARL also provides compendial testing according to USP/NF, BP, EP, JP, and ACS monographs. In addition to our analytical testing capabilities ARL has a microbiology department for sterility, fungal, endotoxin testing, cell culture tests, bacterial and fungal identification, and preservative effectiveness testing.

ARL is registered with the Food and Drug Administration (FDA) as an analytical laboratory and the Drug Enforcement Administration (DEA). Analytical Research Laboratories operates in compliance with the Good Laboratory Practice (GLP) and Current Good Manufacturing Practice (cGMP) requirements.

Forensics/Legal
As a forensic toxicologist, Dr. Kupiec has provided consultation and expert witness testimony in the field of forensic toxicology and pharmaceutical sciences. He has testified in over 100 cases in municipal, state and federal courts, involving both civil and criminal issues.

Research and Development
ARL works with clients daily, utilizing cutting edge technology to develop products ranging from pharmaceuticals, medical devices and over-the-counter products to take to market. These services range from consultation contract to providing full laboratory services and outsource services for pharmaceutical companies.

There are many services ARL can provide to be a full service laboratory or to compliment your current in-house laboratory to meet your outsourcing needs.

Pharmacy Cleanroom Solutions knows <797>. PCS offers everything you need for <797> compliance. We offer a complete line of Cleanroom disposables. Everything you need from Sterile Wipers, Dry Wipers, Sterile Alcohol, Cleanroom Paper, Tacky Mats, Cleaning solutions and tools, to Gloves (sterile and non-sterile), Lab Coats, Hairnets, Shoe covers and Masks.

Our staff Pharmacist has over 30 years of experience and can provide Consultative services to help you assess compliance of existing Rooms thru Gap analysis, Airflow mapping, Sound levels and Construction details or Design consultation for new Cleanrooms. We can also provide Cleaning Validation Kits, and Cleaning Procedure Documents to help you maintain compliance.

We're the only call you need to make.

Other services offered:

Cleanrooms
Pharmacy Cleanroom Solutions is the only cleanroom manufacturer that is dedicated solely to the Healthcare industry. Rooms are designed by a registered Pharmacist, using a modular panel system that can be customized to suit your needs. These rooms can be installed almost anywhere, reducing the need for expensive building projects, thereby reducing your budget outlay, and can be moved and re-configured as future needs arise.

Customization is our specialty, so if you need a custom room or just a few walls or if you require a special sized pass-through, PCS can build it for you!

Equipment
PCS also offers a complete line of equipment (new and refurbished). We have access to all the equipment you need for your pharmacy, hospital or clinic, from BSC, Hoods and Gloveboxes, to autoclaves, thermometers and storage options. Our product list is growing daily, so if you do not see what you are looking for, please contact us for a quote.

Don't overlook PCS for all your disposables such as gowns, sterile gloves, sterile IPA, and all your other disposables for general pharmacy and infusion.

PCS, the only call you need to make for your <797> needs.