The last 20 years have included some of the most significant developments and trends in the pharmaceutical industry. From new classes of drugs, new manufacturing technologies, regulatory initiatives to industry globalization, the pharmaceutical industry isn’t just pharmaceuticals anymore; now we include biotherapeutics, cell and gene therapies, and even prescription digital therapeutics (DTx), and mobile applications! And COVID-19 impacted everything. The global pharma market will exceed $1.5 trillion by 2023. Biosimilars will gain importance to help curb the rising cost of healthcare in the United States. Artificial intelligence and machine learning will continue to impact the identification and development, and manufacture of breakthrough treatments and modalities.
SentrySciences offers a broad range of products specifically designed to meet rigid cGMP and EU-GMP manufacturing standards. Whether for routine or continuous monitoring of Class A, B, C or D areas for particulate, microbial contamination in compliance with ISO 14644-2, or characterizing aggregation in proteinaceous drugs, SentrySciences has the products and expertise to meet your exacting requirements. Our business model and flexibility ensure we design systems that are effective, affordable, and implemented on time. Investigate further visiting our Protein Therapeutics, 503B Pharmacies pages, or by checking out the applications below:
At SentrySciences, our experienced team is familiar with the exacting requirements of aseptic processing and compliance with USP <1116> Microbiological Control and Monitoring of Aseptic Processing Environments. We offer microbial detection products to deliver fixed location, portable and Rapid Microbial Methods (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.
Our portables 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) portable particle counting solutions with battery life greater than 6 hours, and weigh less 15 lbs.; or handheld products with battery life of approximately 4.5 hours of continuous use and weigh less than 2 lbs.
Remote particle counting is simplified with our broad range of particle counters. SentrySciences offers solutions for all your locations and needs. We offer 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!
SentrySciences offers solutions for both Active Air Sampling (AAS), and Rapid Microbial Methods (RMM). We can support you with system design, sampler placement, plate supports, integration with ParticleSentryᴱᴹ, or your existing facility monitoring system. Our product suite includes samplers for portable, fixed location, 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.
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 monitoring data, and countless other probes and process control devices used across your facility with ParticleSentryᴱᴹ solution-focused facility monitoring 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.
SentrySciences has the experience and personnel to bring QbD (Quality By Design) into all aspects of your particle counting and microbial detection processes and system. We can guide you through development of user requirements for a facility monitoring system, design and functional specifications to installation, commissioning and validation and manage the project for on-time, on-budget completion.
In pharmaceutical facilities, contamination control is key to ensuring product sterility. As a result, both space and equipment bio-decontamination have become a regular part of scheduled shutdown maintenance plans. Routine Vaporous-Hydrogen Peroxide (V-PHP) has become the go-to solution for these events because of its advantages to other commonly used sterilization agents, such as chlorine dioxide, formaldehydes, and ethylene oxide. It can be used in low temperatures and is compatible with a wide variety of materials. With the help of precise decontamination cycle control, V-PHP can destroy the full spectrum of biological contaminants due to its ability to oxidize DNA, proteins, and membrane lipids. Another advantage of hydrogen peroxide (H₂O₂) is that it decomposes into water (H₂O) and oxygen (O₂):
Once a bio-decontamination aeration phase is complete, there are no toxic compounds left in the decontamination area and surfaces are left free from chemical residue.
Using Vaporized Hydrogen Peroxide, one can decontaminate a space up to 500m³. Vaporized Hydrogen Peroxide (V-PHP), a common disinfection agent, is used to bio-decontaminate numerous applications including incubators, cleanrooms, and office/clinical spaces. Unlike traditional “Dry Fog”, the vapor process is safe for any computer equipment, electronics, and furniture in the room. “Fogging” technologies work by wetting surfaces with droplets, which pose significant distribution problems for rooms with electrical equipment and/or complex shapes. VPHP attacks the virus at a molecular level.