Analytical Testing & Quality Control Solutions

Leading Providers of Analytical Research, Analytical Testing, Pharmacy Quality Assurance, Pharmacy Quality Control, USP Protocol, Pharmacy Laboratory Services

Analytical Testing & Quality Control Solutions Booth #16110
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Request More Information Visit the Charles River Website

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.





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Analytical Testing & Quality Control Solutions Booth #16197
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Request More Information Visit the ARL Bio Pharma Website

ARL Bio Pharma

ARL Bio Pharma is a contract laboratory. ARL provides analytical and microbiological testing for compounding pharmacies, outsourcing facilities and health-system pharmacies. Our laboratory makes the test process simple so you can meet industry quality requirements and release safe, effective drug products easier and faster.

Laboratory services routinely include:

  • Sterility
  • Rapid Sterility
  • Endotoxin
  • Potency
  • Stability studies
  • Full Compendial Testing
  • Method Development and Validation
  • USP <800> Surface Wipe testing


Non-cGMP and cGMP services are available depending on client requests.


ARL is an ISO 17025:2017 accredited laboratory, FDA registered and DEA licensed.

Request a quote today!

ARL Bio Pharma

800-393-1595

info@arlok.com

www.arlok.com

ARL Bio Pharma, USP <800>, Endotoxin, FDA registered, accredited laboratory, contract laboratory, health-system pharmacies
ARL Bio Pharma
USP 800
Analytical Testing
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Analytical Testing & Quality Control Solutions Booth #16107
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Request More Information Visit the Associates of Cape Cod Inc Website

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.

associates of cape cod incorporated, LAL products, LAL accessories, LAL regents, Chromo-LAL, Instrumentation Software
Associates of Cape Cod, Inc.
LAL Products
LAL Accessories
Software
ACCI Services
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Case Studies Sub Header
Achieving 503A+

Achieving 503A+

Charles River

JSD Pharmacy sets the gold standard for super sterile...

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Analytical Lab Group and DPS Group Demonstrate the Power of Partnership

Analytical Lab Group and DPS Group Demonstrate the Power of Partnership

Element

The stakes are high with getting a vaccine or biotechnology to market. Companies in the antimicrobial, pharmaceutical, and medical device space face regulatory and technology-related challenges every day...

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Fagron Sterile Services Relies on Charles River for Critical QC Testing

Fagron Sterile Services Relies on Charles River for Critical QC Testing

Charles River

The pharmaceutical industry is subject to numerous requirements put in place to ensure the safety
of patients...

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Serious Training Solution From a Single Source

Serious Training Solution From a Single Source

Azzur Labs

How the Power of Partnership Led to Completion of Critical Technical Training for 100+ Employees...

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Rapid ATP-Bioluminescence Testing

Rapid ATP-Bioluminescence Testing

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Delivering accurate, reliable compounding sterility results in days rather than weeks...

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Environmental Monitoring Matters: Going Beyond the USP <797> Standard

Environmental Monitoring Matters: Going Beyond the USP <797> Standard

Charles River

Chapter &lt;797&gt; of the United States Pharmacopeia (USP) outlines the facility and operational requirements for compounding sterile drugs and specifically calls for the collection and monitoring of environmental data through air and surface sampling...

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Will Recombinant Lysate Save The Horseshoe Crabs?

Will Recombinant Lysate Save The Horseshoe Crabs?

Associates of Cape Cod, Inc.

BET White Paper, vol.1 no.4...

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Advancing Health by Supporting Safe Pharmaceutical Compounding

Advancing Health by Supporting Safe Pharmaceutical Compounding

Charles River

Charles River provides a range of microbiological testing services and equipment to support drug discovery, development, and manufacturing that can be tailored to a facility's specific needs and ensure patient safety...

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The Impact of Biomedical Use of Horseshoe Crabs

The Impact of Biomedical Use of Horseshoe Crabs

Associates of Cape Cod, Inc.

BET White Paper, vol. 1 no.3...

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ENDOTOXIN LIMITS For Parenteral Drug Products

ENDOTOXIN LIMITS For Parenteral Drug Products

Associates of Cape Cod, Inc.

BET White Paper, vol.1 no.2

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October 22, 2019 | Product Awareness

The Pyrosate(R) Kit by Associates of Cape Cod Delivers Rapid Endotoxin Testing Results for Compounding Pharmacies [VIDEO]


CPS (Antimicrobial) Case Study

October 21, 2019 | Case Studies

Antimicrobial/Antibiotic Drug Case Study


ALG Laboratory Services

October 17, 2019 | Product Awareness

Customized to Fit Your Product Testing and Environmental Monitoring Needs


USP 797

October 15, 2019 | Training / Professional Development

Understand USP <797> and Sterile Compounding in 9 minutes.


Temptime (Specialty Pharmacy) case study

October 3, 2019 | Case Studies

Leading Specialty Pharmacy Puts Patient Safety and Satisfaction First While Reducing Costs


Associates of Cape Cod

September 25, 2019 | Product Awareness

The Pyrosate(R) Kit by Associates of Cape Cod Delivers Rapid Endotoxin Testing Results for Compounding Pharmacies


Charles River (Advancing Health) Case Study

August 12, 2019 | Case Studies

Advancing Health by Supporting Safe Pharmaceutical Compounding


Associates of Cape Cod

August 6, 2019 | Product Awareness

Our Test, Your Cure - Ensuring A Healthy World


Temptime (Door-to-door) case study

July 29, 2019 | Case Studies

Protecting Patient Outcomes Door-to-Door


Associates of Cape Cod

June 26, 2019 | Product Awareness

Associates of Cape Cod - Delivering Rapid Endotoxin Testing Results for Compounding Pharmacies


Q.I. Medical

June 17, 2019 | Product Awareness

Q.I. Medical | Your Partner in Pharmacy Compliance [Video]


20Ways SUMMER Hospital

June 4, 2019 | Announcements

20Ways SUMMER Hospital 2019 Issue is Here!


Associates of Cape Cod

May 29, 2019 | Product Awareness

Associates of Cape Cod | Pyrosate Rapid Endotoxin Detection Kit [Video]


Temptime

May 29, 2019 | Product Awareness

Temptime | Automated, Affordable Solutions for Real-Time Temperature Monitoring [Video]


Associates of Cape Cod

May 28, 2019 | Product Awareness

Associates of Cape Cod | Our Test, Your Cure- Ensuring a Healthy World [Video]


QI Medical

May 22, 2019 | Product Awareness

Compounding Testing Products for Regulatory Compliance and Quality Assurance


Associates of Cape Cod

May 22, 2019 | Product Awareness

Your Endotoxin Experts


Analytical Lab Group

May 22, 2019 | Product Awareness

Helping Protect Life(TM)


Spotlights by RXinsider

May 21, 2019 | Product Awareness

Meet Pyros Kinetix Flex - A New Endotoxin Testing Solution


Temptime (Specialty Pharmacy) case study video

May 16, 2019 | Case Studies

Leading Specialty Pharmacy Puts Patient Safety and Satisfaction First While Reducing Costs [VIDEO]


Pharmacy Press Release

March 6, 2019 | Press Releases

Rebranding Focuses ALG Mission - Combining Our Best to Bring You Our Best


Associates of Cape Cod

February 17, 2019 | Product Awareness

The Pyrosate(R) Kit by Associates of Cape Cod Delivers Rapid Endotoxin Testing Results for Compounding Pharmacies


Temptime

February 17, 2019 | Product Awareness

Temptime - Temperature Monitoring Solutions for Medication Shipments, Storage, and Pharmacy Facilities


Associates of Cape Cod

February 17, 2019 | Product Awareness

The Pyrosate(R) Kit by Associates of Cape Cod Delivers Rapid Endotoxin Testing Results for Compounding Pharmacies


Associates of Cape Cod

January 4, 2019 | Product Awareness

Associates of Cape Cod -- Delivering Rapid Endotoxin Testing Results for Compounding Pharmacies


Associates of Cape Cod

January 4, 2019 | Product Awareness

Associates of Cape Cod | Pyrosate Rapid Endotoxin Detection Kit [Video]


Q.I. Medical, Inc.

January 4, 2019 | Product Awareness

Q.I. Medical, Inc.(TM) Your Partner in USP <797> Pharmacy Compliance


Associates of Cape Cod

October 17, 2018 | Case Studies

Will Recombinant Lysate Save The Horseshoe Crabs?


Associates of Cape Cod

September 1, 2018 | Product Awareness

The Pyrosate(R) Kit by Associates of Cape Cod Delivers Rapid Endotoxin Testing Results for Compounding Pharmacies


Associates of Cape Cod

September 1, 2018 | Product Awareness

Associates of Cape Cod | Your Endotoxin And Glucan Experts [Video]


Associates of Cape Cod

July 7, 2018 | Product Awareness

OUR TEST, YOUR CURE . . . ENSUR ING A HEALTHY WORLD: Associates of Cape Cod


Associates of Cape Cod

July 7, 2018 | Product Awareness

OUR TEST, YOUR CURE . . . ENSUR ING A HEALTHY WORLD: Associates of Cape Cod [Video]


Associates of Cape Cod

April 7, 2018 | Product Awareness

OUR TEST, YOUR CURE . . . ENSUR ING A HEALTHY WORLD: Associates of Cape Cod [Video]


RDC

April 7, 2018 | Product Awareness

Independent Pharmacy is Our Business - RDC [Video]


Associates of Cape Cod

April 7, 2018 | Product Awareness

OUR TEST, YOUR CURE . . . ENSUR ING A HEALTHY WORLD: Associates of Cape Cod [Video]


Associates of Cape Cod

April 4, 2018 | Case Studies

The Impact of Biomedical Use of Horseshoe Crabs


MQA Platinum Pages Profile

January 31, 2018 | Product Awareness

Quality Science. Quality Service. Quality Results.


Charles River Labs

January 31, 2018 | Product Awareness

QC Microbial Solutions for Compounding Pharmacies


QI Medical

January 31, 2018 | Product Awareness

Compounding Testing Products for Regulatory Compliance and Quality Assurance


MQA Platinum Pages

January 31, 2018 | Product Awareness

Whether you Seek Environmental Monitoring Services, Quality Control, or Analytical Testing...


Associates of Cape Cod Platinum Pages

January 31, 2018 | Product Awareness

Our Test, Your Cure...Ensuring a Healthy World


Analytical Lab Group Platinum Pages 2018 Video

January 31, 2018 | Product Awareness

Whether you Seek Environmental Monitoring Services, Quality Control, or Analytical Testing... [VIDEO]


Associates of Cape Cod Profile

January 31, 2018 | Product Awareness

Your Endotoxin Experts


Associates of Cape Cod

April 3, 2017 | Case Studies

ENDOTOXIN LIMITS For Parenteral Drug Products

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Analytical Testing & Quality Control Solutions


The Relief Products

Franklin Eyewear

Northstar Sales Alliance

TeleCameron Telepharmacist Jobs

Prudential Consultant Broker Services



Innovatix

Noritsu Pharmacy Automation

Uniweb

Opioid Education & Opioid Stewardship

Pill Counter


ISO-MED


Q.I. Medical

Mideast Delivery Solutions

Rx shelving





Return Solutions

PharmID




Allied Pharmacy Products

PDM Healthcare

RXinsider Product Overview Videos


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