Cerilliant Corporation

Cerilliant Corporation

Cerilliant Corporation

Cerilliant Corporation, located in Round Rock, Texas, is a global leader in providing certified reference standards for critical applications. The company has been providing certified reference materials for over 30 years. Cerilliant offers approximately 3,000 catalog products and a full range of custom products and services that address the stringent and complex requirements of the pharmaceutical, clinical diagnostic, clinical/forensic toxicology, natural products, and environmental industries. Cerilliant sustains a modern, robust quality system which incorporates cGMP, GLP, and ISO requirements. We are accredited to ISO Guide 34 and ISO/IEC 17025 and certified to ISO13485 and ISO 9001. Our quality system incorporates GMP and GLP requirements.

Company details

811 Paloma Drive, Suite A , Round Rock , Texas 78665 USA
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Business Type:
Manufacturer
Industry Type:
Pharmaceutical
Market Focus:
Globally (various continents)

This company also provides solutions for other industrial applications.
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Cerilliant is dedicated to producing and providing high quality certified reference standards and certified components for test kits – it is all we do. We have been serving the needs of the analytical testing community for 30 years and are equipped to handle virtually any reference standard, spiking solution, or test kit need. Our team of experts includes numerous PhDs and advance-degreed specialists in science, manufacturing, and quality control, all of whom have a passion for the work they do, thrive in our collaborative atmosphere which values innovative thinking, and approach each day committed to delivering products and service second to none.

Cerilliant offers a full range of high quality products and services that address the stringent and complex requirements of the most demanding clients. We serve a diverse group of customers including private and government laboratories, research institutes, analytical instrument and medical device manufacturers, and pharmaceutical companies and CRO’s — organizations that require reference materials of the highest quality, whether they’re conducting forensic drug testing, clinical toxicology analysis, therapeutic drug monitoring, environmental analysis, pharmaceutical research, or developing new testing apparatus. But we do more than just conduct science on their behalf. We make science smarter. We deliver what our customers need, but never settle for the status quo. We create products that are based on solid, proven scientific principles, but never stop searching for new approaches and better solutions.

At Cerilliant, we believe good chemistry is more than just a process in the lab. It’s also about creating long-term partnerships based on high quality and exceptional service.

Cerilliant Corporation, located in Round Rock, Texas, a suburb of Austin, is a global leader in providing certified reference standards for critical applications. The company has been providing certified reference materials for over 30 years. Cerilliant is an ISO Guide 34 and ISO/IEC 17025 accredited & ISO 13485 and ISO 9001 certified company and has grown to become a world leader in providing a wide variety of high quality reference standards and materials for forensic/toxicology, clinical/diagnostic, environmental, nutraceutical, and pharmaceutical analysis.

Formerly known as the Analytical Reference Materials Division of Radian International, the company began producing chemical reference standards in 1980 to address the needs of the emerging environmental testing industry and was the first to produce 13C labeled chlorinated dioxins and furans in cooperation with Cambridge Isotope Laboratories. Cerilliant was also the first to offer isotope-labeled drugs-of-abuse reference standards to the forensic drug testing industry and pioneered DEA exempt preparations of controlled substances in solution.

In 2000, Radian's parent, URS Corporation, made the decision to divest the division. Cerilliant was formed following the purchase of the division by private investors.

Since its formation in August 2000, Cerilliant has steadily grown from 23 to over 70 employees and serves more than 2000 active customers, including federal and state governmental organizations and laboratories, private laboratories, hospitals, universities, pharmaceutical companies, contract research organizations, and analytical instrument, medical device and test kit manufacturers. Cerilliant's products are distributed throughout the entire world.

In December, 2010, Cerilliant was acquired by Sigma-Aldrich Corporation. Headquartered in St. Louis, Missouri, Sigma-Aldrich is a leading life science and high technology company specializing in chemical and biochemical products and kits used in scientific research, biotechnology, pharmaceutical development, the diagnosis of disease, and as key components in high technology manufacturing.

Cerilliant's operations are located in Round Rock, Texas, just north of Austin, in a light industrial park. Its current operations are housed in approximately 44,000 square feet of leased space, of which approximately 60% is dedicated to its production operations. The remainder of the space is dedicated to sales and administrative functions.

The production area includes segregated suites for organic synthesis work (bench scale to multi-kg); isolation suites for synthesis of toxic, hazardous, or light sensitive materials; cGMP synthesis suites; reference standard manufacturing; ampoule filling, powder filling, packaging; analytical testing; shipping; receiving; and material storage areas for bulk and finished products. Cerilliant’s facility is designed to meet the specifications outlined in cGMP 21CFR211.

Cerilliant's synthesis suites are negative pressure, controlled environments with sophisticated air handling and ventilation systems. Isolation suites and controlled environment chambers are available for the production and handling of toxic and sensitive materials. The cGMP areas are isolated, positive pressure, controlled environments with dedicated and sophisticated air handling, ventilation, and environmental monitoring systems. All production areas are equipped with UV light filters and environmental conditions are continuously electronically monitored. Material storage areas include 4300cf of cold storage, including subfreezer, ambient storage and DEA approved vault storage for controlled substances. All material storage units/areas are mapped and continuously monitored through the use of a validated electronic monitoring system.

The facility is controlled access and is monitored through the use of video surveillance and various electronic alarm components as well as third party monitoring and after-hours security. Critical systems are supported by an uninterrupted power supply and a back-up generator.

Cerilliant is strongly committed to providing a safe and healthful environment for its employees and to protecting the environment. These objectives are accomplished through strict adherence to Cerilliant's written safety programs, the use of emergency alarm systems, personal protective equipment, sophisticated laboratory controls, recycling programs, recycling programs, and conservative waste management.

Cerilliant uses or produces in combination over 3,500 different chemicals or chemical mixtures. To adequately address the health and safety concerns of such diverse chemical usage, all employees are trained in hazard communication, emergency evacuation, and fire safety upon employment. All employees are provided safety orientation and OSHA mandated training is repeated at the prescribed intervals. Medical monitoring is required for all staff involved in the synthesis and handling of chemicals.

The facility is equipped with several different types of equipment that are used for employee and environmental protection. Glove boxes are employed for handling of toxic, potent and sensitive materials. Cerilliant's synthesis suites are negative pressure, controlled environments with sophisticated air handling and ventilation systems. Suites are compartmentalized into smaller rooms (isolation suites) that are negative to the surrounding room to further isolate toxic materials from the general work areas. All synthesis and bulk chemical handling is performed in a laboratory hood or glove box. Production areas are conditioned with one hundred percent fresh air (no recirculation). Suites are also equipped with safety showers, eyewashes, and spill kits for quick decontamination and spill control in emergency situations. Cerilliant provides shower facilities for its production personnel.

For fire protection and suppression the facility is outfitted with ABC fire extinguishers, a water based sprinkler system, Class D extinguishers (where combustible metals are in use) and a monitored fire alarm. This equipment meets all current standards and is inspected at the prescribed intervals. The facility is also equipped with an emergency laboratory alarm system (independent of and in addition to the fire alarm system) to facilitate quick response in the event of an emergency. This system consists of visual alarms that correspond to different hazardous areas and an audible alarm to signal for assistance in an emergency. The emergency buttons are distributed over 16 locations in the facility for easy, quick access during an emergency. This alarm system is third party monitored. The facility also has two 30 minute SCBA units and select staff members are trained on the use of this equipment semi-annually.

Cerilliant's staff includes 25 or more members trained in basic first aid and CPR as well as general emergency response. The production areas are equipped with easily accessible first aid kits and AED and blood bourn pathogen kits for use in an emergency or general first aid needs.

Cerilliant is registered as a large quantity waste generator with the EPA and the Texas Commission on Environmental Quality (TCEQ). Cerilliant is committed to making a minimal impact on the environment and as a result uses incineration as the primary disposal method for laboratory wastes whenever possible. Chemical recycling is also employed where permitted and feasible. Hazardous waste is stored onsite in EPA approved chemical storage buildings outfitted with grated floors and sumps to collect any potential spills and prevent contamination of the outside environment. These chemical storage buildings are also equipped with fire suppression systems in the event of a fire and emergency alarm systems in the event of employee distress.

Cerilliant is proactive in implementing programs aimed at reducing our environmental impact including its recycling programs for paper, glass, plastics, and aluminum, the installation of a state-of-the-art HVAC control system designed to minimize electricity consumption, and the addition of a large solvent recycling system in its cGMP production facility.

Cerilliant is committed to quality at every level of the organization and sustains a robust, comprehensive, modern quality system that incorporates quality by design, risk assessment & management, and vigorous continuous improvement. Our quality foundation is our people — we have assembled a talented and experienced team with an unwavering commitment to quality. We build on that through adherence to rigorous and qualified processes that ensure quality every step of the way and back it up with fully documented proof, through the use of batch records to provide traceability of all materials used, equipment utilized and work performed, and our comprehensive Certificate of Analysis.

Cerilliant’s quality credentials include accreditations to ISO Guide 34, ISO/IEC 17025 and certification to ISO 13485 and ISO 9001. Our quality system incorporates GMP and GLP requirements.

People
People are our foundation. Our deep scientific expertise and diverse backgrounds bring a wide range of knowledge and best practices to every project. It is this collective group of experiences and a collaborative culture that allows us to solve even the most challenging problems.

  • Our team’s expertise is leveraged across the organization from product and project design to execution. We provide comprehensive interdisciplinary solutions to a wide array of customer needs
  • Over 60% of the entire company hold science degrees; more than 25% hold advanced degrees
  • Stringent hiring practices company-wide, including rigorous background checks and drug screens
  • Continuous training and professional development programs ongoing quest for quality built into our culture – day in and day out we strive to provide the very best products and services
  • Comprehensive and rigorous improvement process that involves every employee and all facets of organization – we never stop thinking about improving everything we do and employees are empowered to monitor, maintain and improve at every step
  • Cross-functional teams for product design, process improvement and resolution of problems
  • Leadership team that encourages a collaborative, problem-solving culture that fuels innovation
  • Active participation by management in the design, implementation, monitoring and improvement of the quality system processes

Processes

  • Every project is fully and thoroughly documented in a batch record providing traceability of all components, calibrations and work performed
  • All operating procedures, material test specifications, and analytical methods are fully documented
  • Detailed product specifications established prior to production
  • Multiple levels of review before, during and after each project
  • Quality Assurance team audits each batch record and reviews all data prior to release
  • Full qualification of analytical equipment used for release testing of raw materials and final products
  • All vendors and components evaluated for quality prior to acceptance
  • Physical quarantine of materials awaiting QC
  • Mapped product storage areas with continuous electronic monitoring
  • Validated/qualified analytical methods and techniques
  • Critical production processes and systems are qualified to ensure quality, accuracy and repeatability
  • Full characterization and qualification of neat materials including identity, chromatographic purity, residual water, residual solvent, and residual inorganics
  • Full certification of solution-based products including purity, concentration, ampoule-to-ampoule consistency (homogeneity) as well as lot-to-lot consistency against stringent acceptance criteria
  • Real-time assessment of stability and setting of expiry dates and storage conditions based on scientific data
  • Internal audit programs and corrective / preventive action facilitate monitoring and continuous improvement across all processes and all departments
  • Data archival and backup systems and secondary support systems for critical equipment
  • Strong safety and environmental management programs

Proof
Cerilliant supports each product produced with a comprehensive Certificate of Analysis (COA). Cerilliant COAs for fully certified reference materials include uncertainty information in accordance with ISO Guide 34 and ISO/IEC 17025 and traceability information for satisfaction of regulatory requirements. We also provide full details of all analyses including acceptance criteria and actual results, analytical methods and run conditions, chromatograms and spectral data for raw materials, and analytical verification of solution purity, concentration and homogeneity. Custom COAs and reports can be produced to customer specifications on custom projects. Competency is further demonstrated by our multiple ISO accreditations which ensure that Cerilliant products and services meet the highest industry standards accepted across international borders.