Research, Design & Manufacture
From the research process up to the time of sale, the pharmaceutical community spends countless hours, even years, researching, designing and manufacturing innovative medications. The efforts put forth to develop new drugs and bring them to testing and approval costs more than just the time and energy put into this process. It takes the patience and dedication of those involved, working to protect the integrity of the medication and their workplace.
This requires monitoring of various areas throughout the facility where the medication is being produced, stored and transferred. Typically, this involves an employee stepping away from their integral research to manually record temperatures and conditions for records and documentation. To maintain compliance and meet regulatory standards, these records must be kept consistently and accurately. Proper documentation ensures the safety and integrity of the manufactured products, and missing an outage or incorrectly documenting data could mean the difference between a safe product and product loss.
A Partnership in Efficiency
Immediate. Flexible. Complete.
To maintain efficiency, we begin with a 24/7 continuous monitoring system complete with immediate alert notification via e-mail, text or phone. This means a member of the team gets notified the moment a system enters into alarm, granting them time to properly address the situation, and react in a manner that saves the product involved. No more manual checks for temperature readings or the possibility of missing an outage. The automated system will continually monitor this information for you and alert you in real-time through the software located on your computer system.
Whether you have a few refrigerators or hundreds, no two facilities are identical, and customization is the key to ensuring your continuous monitoring system is where you need it, when you need it. For this reason, alerting can be varied by department, piece of equipment, time of day, day of the week, condition parameters, delivery method and escalation protocols.
The flexibility and scalability of the system means that it can monitor any location, from cold storage to incubators, in any size facility. From a small, single facility, up to a complex, multi-location facility, your continuous monitoring system can adapt and grow as you do. With the option to function as a standalone system or a fully networked environment that can simultaneously monitor hundreds of appliances, you do not need to worry when it comes time to add refrigerators, freezers, or other appliances in your facility. The system has unlimited capacity, making it easy to adjust to where you are and what you need.
“Just wanted to let you know that things went very smoothly with the install. All of the equipment arrived on time. Staff arrive on time and were well prepared/knowledgeable. I know it was not an easy task to make that happen with the last minute issues, but I wanted to thank you all for your work in coordinating and supporting us. It certainly helped make opening a new facility quite a bit easier”
Vaccines are critical tools in maintaining the health of our communities. The logistics of delivering vaccines and verifying that they consistently maintain their recommended temperature has always been a difficult task. At times, vaccines were found being stored outside of the manufacturer’s recommended range. Prolonged temperature excursions can result in the vaccines becoming…
Monitoring Where it Matters
Open/Close Alarm Contacts
Power Line Monitoring
Liquid Nitrogen Units
0-5V and 4-20mA Outputs
Our Clients Include
Regulatory & Compliance
The American Association for Laboratory Animal Science offers Assistant Laboratory Animal Technician (ALAT), Laboratory Animal Technician (LAT), Laboratory Animal Technologist (LATG) and Management Certifications.
The AALAS is a membership association of professionals employed around the world in academia, government, and private industry who are dedicated to the humane care and treatment of laboratory animals, as well as the quality research that leads to scientific gains that benefit people and animals.
To protect our communities, the CDC provides valuable health information and responds to dangerous health threats when they arise. They work to promote healthy, safe behaviors for our communities and environment, using science and technology to prevent disease. The National Institute for Occupational Safety and Health (NIOSH) provides information on how to protect communities by first protecting our employees.
Title 1 of the Drug Quality and Security Act of 2013, the Compounding Quality Act, removes certain provisions from section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA).
- FDA Pharmaceutical Quality/CMC Guidances
- FDA Pharmaceutical Quality/Manufacturing Standards (CGMP)
- International Society for Biological and Environmental Repositories (ISBER)
ISBER is a not-for-profit global organization that address scientific, technical and ethical issues relevant to facilities that handle biological and environmental specimens. blood donate
Vision: ISBER will be the leading global forum for promoting harmonized high quality standards, ethical principles, and innovation in the science and management of biorepositories.
NIST, a non-regulatory agency of the U.S. Department of Commerce, is a measurement standards laboratory. Their research helps to advance the nation’s technology infrastructure and helps facilities improve their products and services.
Vision: NIST will be the world’s leader in creating critical measurement solutions and promoting equitable standards. Our efforts stimulate innovation, foster industrial competitiveness, and improve the quality of life.
The U.S. Pharmacopeial Convention General Chapter 797 describes conditions and practices to prevent harm to patients that could result from microbial contamination, excessive bacterial endotoxins, variability in intended strength, unintended chemical and physical contaminants, and ingredients of inappropriate quality in compounded sterile preparations.
The U.S. Pharmacopeial Convention General Chapter 800 is a proposed revision to USP 797 addressing practice and quality standards for handling hazardous drugs (HDs) to promote patient and worker safety, and environmental protection.