It’s About the Product
Putting years of time and energy into research and resulting products is no small matter. Protecting them isn’t either. Members of the life sciences community have a lot on their shoulders, developing products that affect various aspects of life, from animal science to cell biology, or nanotechnology. Life sciences, simply put, deals with living organisms, and the products affect much of the community in some way.
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.
For facilities that handle Compounded Sterile Preparations (CSPs), new regulations have enforced greater attention to clean rooms for the safety of personnel. Pressure monitoring devices will be instituted in every clean room with immediate alarming capabilities, and particle counters will be installed to automatically track particle counts. This information is easily retrievable through your software for monthly particle counts.
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.
“This is just a note about how very satisfied we are with the work that David Bondi has done for us. Simply put, he is easy to work with, responsive, calm, in tune and communicative. Well, I do not think we have ever had the pleasure of working with a vendor that was just this terrific! Thank you…and please let him know we think he is A#1
PS. Your tech Brian Lewis, who came today for probe re-calibration, was excellent. He was knowledgeable and courteous.“
It is recommended that your Continuous Monitoring (CM) system undergoes a “major tuneup” at least once annually. Although there are monthly or quarterly alarm checks and preventive maintenance schedules to complete, an annual probe calibration to an NIST or ISO 17025-traceable standard and a comprehensive system check/validation will ensure the system is…
Protecting Invaluable Research
Open/Close Alarm Contacts
Power Line Monitoring
Liquid Nitrogen Units
Our Clients Include
Regulatory & Compliance
- Bacteriological Analytical Manual Chapter 23 Microbiological Methods for Cosmetics
Chapter 23 from the FDA discusses methods and schemes for the isolation of microorganisms from cosmetic products.
The U.S. Food and Drug Administration (FDA) website offers a number of Vaccines, Blood and Biologics CBER compliance programs. These programs cover items ranging from the inspection of human cells and tissues, to inspections of testing facilities and biological drug products.
The Federal Food, Drug and Cosmetic Act covers guidelines for cosmetics industries regarding their buildings and facilities, equipment, personnel, raw materials, production and more.
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.