Critical Timelines and Stringent Regulations Are No Match for Charles River Microbial Solutions.

Maintain control and consistency in your compounding processes.

With compounding pharmacy regulations under scrutiny, compliance has never been more important. Maintain control and consistency in your compounding procedures with solutions from Charles River. Offering unmatched regulatory expertise and a portfolio of FDA-licensed products and GMP-compliant services, Charles River is the trusted partner who can help you align your operations with current regulatory standards.

Rapid Endotoxin Testing of Compounded Sterile Products

Required by regulatory bodies for compounding pharmacies, the Bacterial Endotoxins Test (BET) detects unsafe levels of microbial cell wall debris, from live or dead Gram-negative bacteria, that cause fever or septic shock. Unfortunately, traditional BET methods can be costly, requiring skilled analysts and manipulation of cumbersome reagents. The Endosafe® nexgen-PTS™ is a more efficient way to conduct this critical testing. The convenience of the handheld spectrophotometer simplifies endotoxin testing to deliver real-time, point-of-sample quantitative endotoxin results in just 15 minutes. All necessary LAL reagents are condensed into a single disposable cartridge for easy operation and assurance that your products are free of endotoxin within limits set by the United States Pharmacopeia (USP).

Our Endosafe® nexgen-PTS™ endotoxin testing systems provide faster results for improved process efficiency and ease-of-use over traditional methods, while offering additional benefits of portability, improved accuracy, and reproducibility. The LAL cartridges used with the system are licensed by the FDA for in-process and final product release testing of parenterals, such as compounded sterile products (CSPs). The nexgen-PTS™ is fully compatible with USP chapters <85> Bacterial Endotoxins Test and <797> Sterile Compounding, and is the optimum solution for bacterial endotoxins testing of compounded drugs due to its simplicity and speed.

Rapid Microbial Identification for Environmental Monitoring

Confident microbial and particle measurement is critical for your environmental monitoring program to ultimately confirm the security of your compounding area. Accurately identifying an organism to the species, and many times, to the strain level, facilitates tracking of the potential origin of the contamination and prevents delays in product release and completion of investigations.

Charles River offers comprehensive contract microbial testing services from our FDA-registered, cGMP-compliant laboratories. We have supported QC testing for over 1,000 global facilities with our cost-effective microbial identification and strain typing services using our proprietary Accugenix® database, which profiles more relevant microorganisms than any other reference library in the industry. Offering a 98% accurate identification rate and 99% on-time delivery, we have tested and identified more microorganisms than any other company or service laboratory in the industry.

Your Partner for Microbial Solutions

Whether faced with critical timelines or stringent regulations, you can rely on Charles River to ensure the safe manufacture and timely release of your product.

Eagle Analytical Services

Eagle, established in 2003, began as a dedicated partner addressing regulatory needs in the compounding industry. Over the years, it has evolved into a premier scientific solutions provider, with a distinguished FDA-registered CGMP testing/calibration laboratory spanning over 80,000 square feet. Equipped with state-of-the-art instrumentation, cutting-edge technologies, and advanced methodologies, Eagle delivers tailored, high-quality scientific solutions designed to meet the most rigorous industry standards.

Eagle is uniquely positioned to serve a diverse range of clients, including:

• Pharmaceutical drug and device manufacturers
• 503B outsourcing facilities
• 503A compounding pharmacies
• Hospitals pharmacies
• Clinical research organizations

We proudly serve clients throughout North America and globally.

Eagle offers a comprehensive range of scientific solutions. Our laboratory provides analytical chemistry and microbiological testing services for raw materials, medical devices, and finished and compounded pharmaceutical products.

Eagle is the only lab in the USA offering three alternative rapid sterility tests in addition to traditional USP 71 sterility testing, making us an industry leader in rapid sterility testing. With its patent for testing oil-based compounded products on ScanRDI®, Eagle provides a fully compliant 1-day turnaround rapid sterility test. We help our customers reduce quarantine time by up to 90% with these advanced alternative methods.

Our team of experts also handle projects for:

• Cleaning validations
• Disinfectant efficacy testing
• Stability studies
• Sterilization cycle validation
• Depyrogenation cycle validation
• Aseptic process validation
• and any other special project upon request

Our consulting team provides customized GAP audits, due diligence audits, regulatory responses, SOP development, environmental monitoring solutions, designated person competency assessment and any other needs upon request. In addition, our engineering specialists excel in facility design, cleanroom certifications, smoke studies, equipment calibration and equipment qualification (IQ/OQ/PQ).

As part of our comprehensive Environmental Monitoring (EM) solutions, we provide TSA (Tryptic Soy Agar) plates in two convenient sizes, designed for both personnel monitoring and surface sampling. In addition to our high-quality plates, we offer a range of complementary services to support your monitoring needs:

• Incubation and Enumeration of Media
• Microbial Identification
• Temperature Mapping
• Incubation Qualification

To verify the efficacy of cleaning programs, we offer SurfaceShield, a wipe sampling kit designed to detect both hazardous and non-hazardous drugs on surfaces. This versatile and cost-effective kit supports achieving and maintaining USP <800> compliance and meeting Title 21 Part 211 CFR requirements. Additionally, we test for the majority of drugs listed in the NIOSH guidelines.

These integrated services ensure precise and reliable results, helping you maintain the highest standards of quality and compliance.

With our broad expertise, Eagle is your all-in-one solution provider.

Associates of Cape Cod Inc

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.

Temperature Monitoring

Find practical, proven solutions for Temperature Monitoring and management.
From medical-grade data loggers, temperature recorders and thermometers to portable refrigerators, medication warmers and more, HCL offers virtually everything imaginable to protect and secure temperature-sensitive medications throughout your facility.

Enjoy wireless convenience to recorded temperature information with DataPad, a handheld touch screen device that allows users of EL-USB data loggers to download data and view results on the spot. This convenient temperature monitoring tool eliminates the need to remove the logger from the refrigerator or freezer and take it to a computer to retrieve information. It also allows the full setup of loggers and configuration of units directly from the field.

Refrigerator Locking Boxes keep supplies safe and secure and enable users to control access to temperature sensitive drugs while keeping them stored at a regulated temperature. Achieve an additional layer of protection for refrigerated meds with Lockable Thermostat Covers that help control thermostat settings so only authorized personnel have access.

Visit our site to learn more about our full inventory of Temperature Monitoring solutions. If you don’t find what you’re looking for, our talented team of product experts is ready to help!