Associates of Cape Cod, Inc. (ACC), is one of the world's largest manufacturers of products developed to detect and quantify gram-negative bacterial endotoxins and (1-3)-ß-D-glucans. Our products are used worldwide by leading pharmaceutical and medical device companies to ensure the safety of their parenteral drugs, biological products and medical devices. Our goal is to provide the best products and services, as well as the best technical support and customer service, in our industry to enhance the productivity and efficiency of all our customers. We are ISO 13485: 2003 certified, our laboratories are FDA Inspected and DEA Licensed and our Beacon Diagnostics ® laboratory is CLIA certified.

LAL Products

ACC is one of the world's largest manufacturers of products developed to detect and quantify gram-negative bacterial endotoxins and (1-3)-ß-D-glucans. Our products are used worldwide by leading pharmaceutical and medical device companies to ensure the safety of their parenteral drugs, biological products, and medical devices. Our Customer Service, Technical Service, and Contract Testing teams are ready to assist you with all aspects of endotoxin and glucan testing.

LAL Accessory Products

Pyroclear® Accessory Products
Pyroclear Pyroclear® brand accessory products are the first products in the industry that are certified to be free of interfering endotoxin and (1-3)-ß-D-glucan contamination. Pyroclear brand certified products include depyrogenated test tubes, 96-well microplates, pipette tips and LAL Reagent water. These products are designed to reduce Out of Specification (OOS) investigations due to contaminated accessories.

Instrumentation

ACC is proud to offer a variety of instrumentation to support all your testing needs. Instruments like our Pyros Kinetix® incubating kinetic tube reader which offers the highest turbidimetric assay sensitivity in the industry. Bridge the gap between the affordability of filter-based readers and flexibility of monochromator-based systems with our VersaMax­™ microplate reader.

LAL Research Products

ACC offers a complete suite of reliable, easy to use research products. Developed for research purposes only, ACC's Research Products are designed to improve pyrogen testing while offering our high standard of effectiveness.

Instrumentation Software

Precise, easy-to-interpret data is an essential part of kinetic endotoxin detection programs. ACC offers three software packages designed to improve the efficiency and the compliance of your testing program all featuring 21 CFR Part 11 compliance, dynamic reporting options and increased data security.

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.

Analytical Research Laboratories (ARL), a division of ARL Biopharma, has been serving the pharmaceutical and health-related industries since 1994. With over 100 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.

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.

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.

The parent company of Analytical Research Laboratories, ARL Biopharma, also holds the renowned DNA testing company DNA Solutions. DNA Solutions is leading the trend in looking to the future of medical treatments including pharmacogenomics and gene therapy. By having the capability to provide analytical testing services as well as the DNA testing and sequencing services the possibilities are limitless with ARL Biopharma.

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.

When you Think Quality, Think Eagle

Eagle Analytical Services specializes in Quality Assurance/Quality Control testing for the compounding pharmacist. QA and QC are becoming ever more important in today’s compounding pharmacy environment. Heightened public awareness, increased regulatory attention, and most importantly, the desire of pharmacists to provide the highest quality preparations for their patients, while improving their pharmacy operations, have all created increased interest in QA and QC. Dedicated to the unique needs of compounding pharmacies, Eagle provides USP Sterility (bacterial and fungal), USP Endotoxin and active ingredient Potency Testing. For rapid sterility testing, Eagle Analytical is unique in providing the Chemunex Scan RDI™ Rapid Microbial Detection Protocol. Eagle Analytical follows USP protocols for all microbiological and potency testing. Accurate compositional analysis is performed using HPLC systems with USP or other certified reference standards. Online laboratory reports are available, and lab results are archived for easy retrieval. Other tests, package and volume pricing, as well as rush services are available.

Specialized QA/QC Testing for the Compounding Pharmacist

• Dedicated to the unique needs of compounding
• Testing to USP and other certified standards
• Modern state-of-the-art laboratory, cleanroom and instrumentation
• All primary data stored in 21 CFR 11 data files
• Microbial Detection using the Chemunex ScanRDIÆ Protocol
• USP <71> Membrane Filtration Test
• USP <85> Bacterial Endotoxin Testing
• Potency to USP protocols for accurate compositional analysis performed using HPLC systems
• Online laboratory reports available

Testing Services Offered

• Rapid ScanRDI® Bacteria, Mold, and Fungal Test
• Sterility - Bacteria, Mold, and Fungal Test
• Bacterial Endotoxins
• Potency
• Potency Over Time Studies to Determine Beyond-Use Dating of Compounded Preparations
• Other tests, package and volume pricing, as well as rush services are available

Visit our website for details regarding samples sizes required for analysis and a sample submission form. Or, call Eagle Analytical at 800/745-8916, today!