You’re an expert at compounding, not an expert in particle and microbial monitoring? We can help! SentrySciences can simplify compliance with USP<797> Pharmaceutical Compounding – Sterile Preparation, and help you develop monitoring protocols for your compounded sterile preparations (CSP’s). Our microbial contamination solutions include both particle and viable particle counters for portable or fixed installation.
SentrySciences has the experience and personnel to bring QbD (Quality By Design) into all aspects of USP<797> compliance for your facility. Microbial contamination, airborne particle and viable particle counters, monitoring processes and systems are our lifeblood. We can guide you through development of user requirements, system design and functional specifications to installation, commissioning and validation and manage the project for on-time, on-budget completion.
Too many separate data streams? Bring it all together with ParticleSentryᴱᴹ. Let us help you integrate differential pressure, air velocity, temperature and humidity, particle and viable particle monitoring data, and countless other probes and process control devices used across your facility using our ParticleSentryᴱᴹ solution-based products. Our software delivers flexible data collection, redundant and fault-tolerant data integrity and compliance with GMP and FDA requirements for 21 CFR Part 11. Our talented team can integrate communication with virtually any other platform via OPC UA Client/Server.
If you've already got systems and processes - we can provide objective risk-assessments to improve what is already in place, or help you integrate data streams into your existing system.
At SentrySciences, our experienced team is familiar with the exacting requirements of aseptic processing and compliance with both USP<797> Pharmaceutical Compounding-Sterile Preparations and USP<1116> Microbiological Control and Monitoring of Aseptic Processing Environments. We offer microbial contamination solutions for viable particles like Active Air Sampling (AAS), and Rapid Microbial Detection (RMM). Our solution-focused approach to your unique restricted-access barrier systems (RABS), clean room and isolator requirements will help to ensure your microbiological risk analysis delivers robust solutions to meet the rigorous sterile requirements for Class A aseptic filling suites and related applications. We can support you with system design, sampler placement, plate supports, and integration with ParticleSentryᴱᴹ, or your existing facility monitoring system. Our product suite includes microbial samplers for portable, fixed location and compressed gases and includes a full range of mounting accessories. These components are critical for Class A Aseptic Filling suites, bioburden, and contamination in WFI, and plant DI water supplies.
Our portable particle counters include on-board global regulatory guidance and international standards for ISO 14644-1:2015 and EU GMP Annex 1 and make cleanroom classification testing simple. SentrySciences offers standard and high flow (50 or 100 LPM) portables with battery life greater than 6 hours and weigh less than 15 lbs.; or handheld products with battery life of approximately 4.5 hours of continuous use and weigh less than 2 lbs. Remote and fixed location particle counting is simplified with our broad range of products. We offer solutions for all your locations and needs! Our solutions include remote counters that can operate on house vacuum, counters that have onboard pumps, large instrument data buffers, Wi-Fi® communication and worry-free cleaning with sealed inlets and even VHP resistant options. And if that isn’t flexible enough, our portables can work in fixed locations!