Particle Monitoring Systems
Particle Monitoring Systems
Latest generation particle monitoring systems for industry professionals. At Alpha Scientific, our staff have been involved in the supply of NATA calibrated, fully validated and GMP compliant particle monitoring systems for close to 40 years. Our staff in fact supplied some of the very first particle monitoring systems of their type into the Australian & New Zealand markets decades ago.
We are familiar with and have sold numerous brands of wired and wireless environmental monitoring systems over time and we have seen the pros and cons of these different systems.
The particle monitoring systems and instruments we provide today are the best and most flexible we have found in the marketplace. They are chosen specifically with the customer in mind and to provide facilities with high quality solutions and as much flexibility as possible.
Our Pharmagraph particle monitoring systems are used by hundreds of leading pharmaceutical companies, hospitals, compounding pharmacies and other organizations throughout Australia and the world.
Our particle monitoring systems are fully compliant with ISO 14644-2, EU GMP Annex 1, PICs PE 009 and other global standards and they are fully validated and high quality documentation is provided with every system supplied.
World Leading Fully GMP Compliant Software Platforms
State-of-the-art, latest generation software platforms specifically dedicated for particle and environmental monitoring in GMP facilities. Fully compliant with the latest EU-GMP Annex 1, cGMP, GAMP, PIC/S PE-009 and other global standards. Highly stable and reliable operation on physical servers or virtual machines. Used by leading pharmaceutical manufacturers, hospitals and countless other GMP facilities throughout Australia and the world, these platforms offer unprecedented flexibility when compared to many other highly proprietary platforms on the market.
Support for Many Brands of Particle Counters & Instruments
Unlike many vendor specific software platforms and environmental monitoring systems which lock customers in to using their specific particle counters indefinately, our monitoring systems and software platforms support a wide range of different brands, makes and models of particle counters available on the market. This makes it not only possible for facilities to try and use different brands of particle counters, it allows them to negotiate with different vendors to secure the best pricing and it makes it easy for them to upgrade and change vendors if so desired.
Faster & More Efficient System Upgrades for Facilities
Stuck with an outdated monitoring system and wanting to upgrade ? You have done some research and found that you can’t upgrade or to upgrade and change to another supplier will cost you a fortune in having to throw away your existing particle counters and other hardware / software, only to be then locked in again to a new supplier. Upgrading is an industry wide problem which has plagued facilities for many years. Our monitoring system platforms are highly flexible and can be rolled into facilities in many cases without having to discard most of your existing system.
New State-of-the-art System Installations
Our state-of-the-art Pharmagraph particle and environmental monitoring systems are extensively used by hundreds of leading organizations throughout Australia and the world. These systems are extremely reliable and offer unprecidented flexibility when compared to many other monitoring systems on the market. Our Pharmagraph platforms also support many different brands of particle counters on the market with this number growing all the time. This unlocks facilities from being totally reliant on and locked into one specific vendor and their brand of particle counters.
Fully 21 CFR Part 11 Compliant for Peace of Mind
21 CFR part 11 compliance is assured through the use of tight security, proprietary binary logging and provision of an audit trail. The software is secured via unique usernames and passwords, with auto log out when the system is left idle. A secure binary format is used for data log files making it impossible to alter records. An audit trail logger automatically tracks changes to the system configuration, recording what has been changed, by whom, when and for what reason. The audit trail logger also records operator log in and log out activity, including failed log in attempts.
Fully NATA Calibrated & Validated World Class Solutions
Designed for pharmaceutical manufacturers, hospitals & other GMP facilities, our world class Pharmagraph environmental monitoring systems incorporate fully NATA calibrated particle & environmental sensors along with easily accessable industry standard components. We only utlize the highest quality sensors from proven, tried and tested sensor manufacturers and everything is professionally installed, commissioned and validated, with the customer receiving high quality validation documentation for inspection and sign off during the process.
Outstanding Data Integrity, Security & Redundancy
Data integrity, security and redundancy is paramount in any environmental monitoring system and nobody does this better than Pharmagraph. Our systems have no data gap issues like some other systems on the market, our I/O cabinets power, retrieve and store particle and environmental data, even in the event of complete power loss. We offer hot standby functionlity, data back filling, backup server capabilities, network data storage options and many other data storage countermeasures in an effort to protect customers valubale data.
Smart Algorithms & Forward Prediction Analysis
Amongst the many other industry leading features, these highly advanced platforms also offer cubic meter particle monitoring to reduce system down times and an “Out of Compliance Predictor” and “Cubic Meter Event Monitoring” for the non-viable particle counting element of filling lines. The Out of Compliance Predictor enables filling line systems to predict out of compliance operation and offers corrective action to be taken before alarm conditions occur, thereby avoiding investigations, write ups and prolonged system down times.
Batch Reporting, Instrument Tracking & Much More
Process templates can be configured to suit particular product campaigns and saved on the system. Batch reports can then be generated for specific production runs within a product campaign. This package provides up to six electronic signees, such as operator, supervisor / reviewer, QC and QP, who can apply their electronic signature to enable batch release. Instrument tracking enables personnel to know exactly which instruments were used in which sampling positions at all times. Calibration due alerts is also a popular feature many customers ask about.
Automated & Continuous Microbial Monitoring Integration
Automated & continuous real-time microbial monitoring is growing in popularity. Just as facilities monitor non viable particles in real-time, the ability to monitor viable particles is now a reality. One of the many key features of our systems is the ability to integrate continuous real-time viable / microbial monitoring. Our software platforms are incredibly flexible and can even be customized to communicate with and collect data from other systems and equipment. This flexibility is highly sought after and it pays to install an environmental monitoring system that can support it.
National Systems Integration Network
At Alpha Scientific, we work for the customer and want what’s in the customers best interest. We know from decades of experience that trying to fly suppliers in from other states to support your system is both time consuming and costly. Delays and downtime costs companies money each and every day in this industry. In an industry first, in 2020 we established a national network of system integration partners. This network continues to grow and be refined while delivering fast, local and cost effective system installations, upgrades and ongoing technical support for customers.
National Calibration Services Network
Environmental sensor calibrations, vacuum system maintenance and other EMS related tasks can easily be undertaken in most states and territories without the need to fly suppliers in from interstate at considerable ongoing cost to facilities. Our national calibration services network has been operating since 2020 and incorporates a wide range of highly experienced NATA laboratories and related service providers. These network partners are proving highly valuable to our customers in providing fast, reliable, high quality and local ongoing calibration support.
- Our Pharmagraph enVigil V platforms offer support for many brands of particle counters, active air samplers and environmental sensors
- Modern dashboard interface gives ability to show high level stats and system parameters
- Server clusters support multiple network clients sharing information
- Cloud connectivity enables data to be sent to third party applications
- SQL Data to third party databases
- Multi-level mimic diagrams
- Trend displays with multiple cursors
- Reconciled alarm reports with Trend Metrics
- Touch screen clients, Tablets, Alarm message displays and beacons
- Interfaces to external systems via OPC, ModBus and ODBC/SQL database applications
- SMS text and email alerts
- Server/Client architecture with network clients
- Hot standby functionality (optional)
- Batch reporting with electronic signatures
- Installed on Windows 10, Windows Server and virtual machine Windows OS platforms
- Free software updates & more
Particle Monitoring Systems
Particle monitoring systems are invaluable to facilities in being able to continuously monitor and record viable and non viable particles and other environmental parameters in real-time. Particle monitoring systems may be used in many types of facilities including hospitals, pharmaceutical companies, compounding facilities, bone banks, blood banks, semiconductor facilities and many others.
Selecting the right particle monitoring system can prove to be a real challenge with many suppliers claiming to have the best solution. At Alpha Scientific, we offer many solutions and our staff and associates have decades of experience in this industry. We work with leading ISO 17025 accredited NATA laboratories, consultants, our system integration partners and a wide range of industry professionals across Australasia and the world.