Clean Room Monitoring Systems
Brookhaven deliver, install & validate particle counters, Microbial Air Samplers and Monitoring Systems for clean rooms and other GMP critical areas. Our systems can monitor particle, microbial, differential pressure, temperature, humidity & other critical parameters.
You request – we design!
Monitoring System Architecture
We shall relive our customers from the burden of compliance
When you invest in a monitoring system from Brookhaven you can be sure that you will be in compliance from the beginning. Our system will meet the requirements from FDA, EC-GMP & ISO. This is possible since all our project phases from design & installation through qualification & handover are executed according to the GAMP5 guidelines for GxP Computerized Systems.
Typical parameters that we monitor are:
Environmental Monitoring
In a clean room there are many parameters to monitor to make sure that the room stays in a controlled condition. Some of the most common parameters that are monitored includes:
- Room Temperature
- Room Humidity
- Room Differential Pressure
Particle Monitoring
When your need for continuous particle counting is established we have many different particle sensor to choose from for integration into a monitoring system. Maybe you have have a need for a VHP resistant particle sensor or with a built in pump We know what is best for your application.
We can offer data communication via
- 4-20mA,
- RS-485 or
- TCP/IP.
We also design our own solutions for installation of the particle sensor like a stainless steel box with inspections window and a isokinetic sampling probe with a unique lid that can be fitted on top when cleaning is performed.
Automated Microbial Sampling
We can deliver a fully automated microbial sampling solution. It means that for your most critical areas in a grade A & B environment where you would monitor for micro organisms on a day to day basis we can simplify that work for you.
A microbial sampling head is installed at a fixed location at your critical points. The sampling head can be controlled via an operator panel where start & stop is executed. Within the monitoring software the measuring point name, start & stop time, who started the measurement and any potential flow failure is recorded. This can later be printed together with your batch report. You can also if wanted record your microbial data after incubation. The head is compatible with 90mm petri dishes.
Monitoring Software
In our system we use a software that is developed for one purpose only, to monitor critical parameters like particles, micro organisms, differential pressure, temperature and humidity etc. It is a GAMP 5 category 4 software (configurable software).
It is fully validated and comes delivered with a complete lifecycle documentation. It uses a modern SQL database which ensures a flexible and stable data collection and storage. The software is supported by all the Nordic languages and it can be used together with touch panels, SMS and E-mail services. It is also compatible with OPC UA server solutions.
Communication Cabinet
The communication cabinet is the central part of the monitoring system. All communication with surrounding input & output parameters is routed through the cabinet. In the cabinet we mount devices like:
- Analog Input
- Digital I/O
- Relay Output
- RS-485 to TCP/IP
- Network Switch
- 24V Power Supply
- UPS
- SMS Modem
Control & Automation
There might be processes that you would like to automate or control. Examples of those are:
- Digital signals to & from process equipment
- Controlled changes of alarm limits
- Changes in ventilation speed
- Switching of valves
- Web Camera Monitoring
Equipment Monitoring
Any equipment that is critical for your process we can monitor. The equipment may have a built in sensors that supplies a 4-20mA or 0-10V signal or we install a sensor for it. Examples of critical parameters are:
- Incubators
- Refrigerators & Freezers
- Ultra Low Temperature Freezers
- Air Flow
- Gases
- TOC & Conductivity
Alarms & Human Machine Interface
The monitored process parameters and alarms might need to be displayed for the operator or supervisors. We offer several solutions like:
- Clean Room Operator Panel
- Alarm Beacon
- SMS
- VPN-Client
- Security Call Center
Project Lifecycle
Brookhaven offer full validation of the monitoring system including life cycle documentation according to GAMP5 and VPCS from ISPE. We also supply complete software design & validation documentation.
System Idea
It all starts off with an idea from your side. Either you already have a monitoring system that needs to be upgraded with critical parameters, sofware version or you are installing a new system. If you want we can help you with inputs to write a Risk Assessment Document to verify that all the critical parameters within the monitoring system is covered. From the Risk based approach a URS (User Requirement Specification) is developed to make sure that all your requirements for a monitoring system are specified.
System Implementation
We offer an comprehensive validation package to make sure you are in compliance with the regulatory demands. Since we have extensive experience from working with the Pharmaceutical Industry we write our own documentation. We implement our systems according to our own GAMP 5 V modell.
Maintennance & Service
When you have made an investment in a monitoring system or instrument you want to make sure that it will be in good condition and running for as long as possible without any major failures. We offer many levels of service agreements such as:
- Calibration on particle , microbial and environmental sensors at our calibration laboratory or on site with our specially designed calibration bus.
- Extended warranty on system parts or the complete system including travel & labor costs.
- Yearly re-qualification of the system to maintain the validated state.
Decommissioning
When your system or parts of the system comes to the end of the lifecycle we can help you with executing a controlled decommissioning. This could include:
- Final backup of data
- Final calibration of sensors
- Final tests to verify that the system were in a validated state
- Decommissioning Report