Virtual Pharmacy Trade Show:
USP <797> Compliance

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 is the only cleanroom manufacturer that is dedicated solely to healthcare. Rooms are designed and built by a registered Pharmacist and offers a complete line of equipment (new and refurbished) as well as disposables.

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!

Other services offered:

Clean Room Supplies
JCL carries a full line of products for 797 compliance. Everything you need from Sterile Wipers, Dry Wipers, Sterile Alcohol, Cleanroom Paper, Tacky Mats, Cleaning Validation Kits, Cleanroom Mops, Gloves (sterile and non-sterile), Hairnets, Shoecovers, Gowns, etc.

Chemicals for the Compounding Pharmacy
We have a full line of chemicals for the compounding pharmacy. Inhalation, HRT, Pain Management, Infusion. Some of these chemicals are listed on the order form. If you are looking for something specific, please contact us and we will be happy to provide you with a competitive quote.

Equipment
JCL Medical has all the equipment you need for your pharmacy, hospital or clinic. Our product list is growing daily. 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 disposable for general pharmacy and infusion.

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

A.R.T. (Accurate Recording Technology) by Carter-Health is an online documentation software product that allows users to completely manage activities associated with USP 797 sterile compounding activities. As an online resource, the healthcare facility does not have to worry about integration of the product onto its network, making implementation quick and seamless. Pharmacy directors will have the confidence in an industry leading software product to record, manage and retrieve data that was developed with the help of their colleagues.

With the daily pressures of having to meet budget, A.R.T. was developed as an economical solution to help pharmacies keep record of the numerous activities required by USP 797.

Some of the features of A.R.T.:

• Online, secure documentation of data
• Various user-level sign-in
• Personnel, equipment and environment documentation
• Comparison performance among staff, facility and system
• Charting and graphing of data
• Ability to upload policies and procedures
• Personnel testing
• Instantaneous input of room certification results by third party vendors
• Reference guide
• Cleanroom video guide
• Unlimited number of user access
• Local and remote alerts (email, paging, text phone)
• Technical support

Other Add-on Features:

• Personnel Scheduling
• Inventory Management
• Online ordering of disposable products

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.