REAL TIME MONITORING SYSTEMS
The cleanroom environment is very dynamic with products and personnel moving and changing, thus contamination events can happen at any time. Real time monitoring enables you to know when the environment is not safe for building the products.
Particle shedding events are rarely predictable, and can happen at random times throughout the day. Monitoring this environment on a continuous automated basis will help to catch these types of issues before they get out of control or affect production. Millions of dollars worth of products can pass through a cleanroom on a daily basis depending on the type of facility. Finding out about a contamination problem a day or two late could be an expensive and/or catastrophic situation.
In addition, the ability to recall historical data is a very valuable tool to have. Reports serve as records that can be used to present supporting data to customers, government organizations, and regulatory committees.
Acumen can assist you with a complete environmental monitoring system via sensors and software packages available through Lighthouse Worldwide Solutions. Information on environmental sensors can be found here, while information on the software options is below.
Ease of Use
LMS Pharma and LMS Pro were designed with an ICON driven user interface which greatly simplifies the user experience.
Color coded status and unique shaped ICONS enhance the already intuitive user interface.
Lighthouse software allows you to be continuously monitoring your Cleanroom throughout the 24/7. As an excursion occurs, you will be notified immediately to respond to problems as they occur. The software will allow you to integrate as many sensors as you would like.
Capability to Monitor Other Environmental Parameters
With Lighthouse monitoring software, you will be able to monitor multiple environmental parameters. All of this data can be integrated into your Lighthouse software of choice. This will allow you to have all of your data centrally located and you can setup alarms based upon these parameters.
Data at Your Fingertips
With LMS Pharma or LMS Pro software, get data when, where and in the format you need it. Whether you are at your desk, or at any computer on your network, you can access all of the data you need.
View your data in multiple formats:
- Real Time Maps
- Real Time/Historical Graphs
- Real Time/Historical Data Tables
- Grid Tables
- Alarm Logs
- Event Logs
- Compliance Reports.
- Batch and Lot Reports
Environmental monitoring of critical operations is required by various GMP regulations and must occur before and during these operations without exception. LMS Pharma and LMS Pro systems can be configured with (optional) data collection redundancy to automatically record your data to two databases simultaneously. With mirrored databases if the main computer fails, the secondary will automatically take over data collection, thus providing you with uninterrupted data collections and alarming.
21 CFR Part 11
With unique user ID, password protection, a secure database, auto logout, and password aging, Lighthouse software was designed for 21 CFR Part 11 Compliance.
100% Turnkey Solutions
Lighthouse World Wide Solutions offers comprehensive Project Management services for our Monitoring Systems projects. Our Project Managers manage monitoring systems projects 100% of the time and we have been perfecting our project delivery for over 25 years. With dedicated Project Manager you can be sure your Monitoring Systems project will be delivered on time and within budget.
In the pharmaceutical and biotechnology industries, validation refers to establishing documented evidence that a process or system, when operated within established parameters, can perform effectively and reproducibly to produce a medical product meeting its predetermined specifications and quality attributes. Lighthouse offers validation management and documentation for the particle counters and LMS Pharma and LMS Pro monitoring systems we provide to our customers. We follow established cGAMP guidelines for system validation.
Lighthouse is also able to offer IQ/OQ Validation Services for the LMS Express Software. Otherwise, we can provide you with self-executable IQ/OQ documents which would allow you to validate the documents on your own. Our Validation Documents are designed to meet the stringent requirements of today's regulations and guidelines.
Real Time Monitoring out of the Box
The EMS (Express Monitoring) System is a quick, easy, low cost solution to monitor your critical environments and at the same time achieve compliance with your industry guidelines.
Designed to be a preconfigured, easily installed system by the customer inside of their cleanroom or environment for a continuous Environmental Monitoring System. This simple and easy to use solution allows you to install and set up with ease. Installation manuals will be supplied to support the installation and set up process.
The EMS System monitors critical environmental and process parameters such as temperature, humidity, differential pressure, particle counts, carbon dioxide and many other environmental parameters.
- Real time monitoring out of the box
- 21 CFR Part 11 compliant software
- Pre-configured system
- Real time & historical data analysis
- Alarm notification: e-mail/alarm lights
- Self-executable IQ/OQ documents
- SOP's included as part of the package
- NIST traceable calibration
- Installation manuals
- All sensors come with 2 year warranty
Acumen Technology is proud to offer microbial samplers produced by Lighthouse Worldwide Solutions, the world’s leading supplier of real time contamination monitoring systems and airborne particle counters.
The company has leveraged its superior software design, data integration ability and worldwide support offices to provide its customers with leading edge contamination monitoring solutions. These solutions have allowed Lighthouse’s customers to maintain high product yields through continuously monitoring conditions that may have an adverse effect on their products. The Lighthouse Monitoring System and Lighthouse line of airborne particle counters have become the standard for many companies, such as Seagate, Western Digital, TSMC, Samsung, Hewlett Packard, Motorola, Hitachi, Maxtor, Lockheed Martin, Microchip, Medtronic, Fujitsu and many more.