Given the constantly changing GMP and compliance requirements, the applicable standards and the fact that continuous cleanroom monitoring is a fundamental process tool for monitoring the aseptic manufacturing environment. It is therefore crucial that planning, design, procurement, implementation, validation and the maintenance are organized carefully.
Bakrona implements total solutions for continuous clean room monitoring in the GMP area and supplies the associated sensors, such as particle counters and microbial air samplers for clean room monitoring. Our clean room monitoring systems meet cGMP requirements.
CLOSE TO THE CUSTOMER
With clean room monitoring systems, it is critical to be on site quickly when a problem occurs in order to keep the monitoring downtime as short as possible. With our Swiss presence and many years of experience in clean room monitoring, we are able to provide quick and short-term support to our customers in pharmaceutical and biotech production as well as in the health care and medical device sector.
The monitoring system is planned and designed using a risk assessment based on the client's URS. Questions about the environmental parameters to be monitored, the use of particle counters and air samplers for the monitoring of non-viable and viable air particles or the number and locations of the sampling points are assessed based on a risk analysis.
Real-time particle monitoring includes the use of permanently installed particle sensors at locations where critical and sensitive processes are monitored. The seamless process monitoring detects contamination and particles are counted per cubic foot or meter. In the event of a critical event, an alarm is automatically triggered.
FACILITY MONITORING SYSTEMs (FMS)
Aerosol particle counters are an important part of environmental monitoring, in which the air quality is monitored as part of the system qualification. The determination of the air purity is also necessary in critical areas in which there is a high risk of contamination. The particle counters are part of a larger environmental parameter monitoring system, which includes the following elements:
- Monitoring of non-viable airborne particles
- Viable particle monitoring of air, surfaces and personnel
- Pressure difference monitoring
- Monitoring of temperature and relative humidity
CONTINUOUS MONITORING OF AIR QUALITY
The particle counters are integrated into a software-based monitoring system, which handles the data acquisition, reporting and alarming. Facility management systems can be part of a larger laboratory information management system (LIMS).
Monitoring and data collection provide evidence that critical environments are under control before and during the manufacturing process. All equipment, systems or facilities used to manufacture drugs should be validated and kept in a validated condition.
The FMS is a project that requires planning, qualification and validation. A risk-based approach should be used to determine the scope of validation. In doing so, risks must be systematically assessed by reviewing the manufacturing processes and activities in relation to equipment, facilities and personnel.
The main risk with a facility management system is air quality in the manufacturing process environment. Although there are different approaches of varying complexity to risk assessment, some sort of assessment system should be used. Regardless of the approach used, the following points should be considered.
- Identify operations with a high risk of contamination
- Determine the optimal sampling locations
- Monitoring frequency with alarm and action limits.
- Systematic review of the proper functioning of the monitoring system
- Ensuring the calibrated condition of the facility monitoring system
BAKRONA MONITORING SYSTEMS
You will be looked after by competent and experienced specialists right from the start of the project. Bakrona supports you in all specification phases (URS, FS / DS) and carries out the commissioning including complete system qualification (FAT, IQ / OQ, SAT) as well as training.
Bakrona Monitoring turnkey solutions are implemented with components from well-known manufacturers. We integrate our sensors for particle surveillance and other environmental parameters into your application. After the project has been completed, you can benefit from our maintenance and calibration services.
FOR MORE INFORMATION
061 695 82 82
WHAT YOU NEED TO CONSIDER WITH A FACILITY MANAGEMENT SYSTEM
Annex 1 of the EU GMP stipulates that clean rooms must be monitored during operation, the monitoring locations being based on a formal risk analysis and the results of the classification of the clean rooms. Critical areas exist where a product susceptible to contamination is exposed to the environment without the containers being sterilized immediately afterwards. Typical high risk areas in manufacturing are:
- The filling zone (where containers are filled).
- Stopper bowls (where stoppers are stored and loaded, in Zone A before filling).
- Inserting the stopper (the stoppers are inserted into filled containers).
- Loading areas for freeze drying (where partially closed vials are loaded into freeze dryers).
- Isolator transfer devices.
- Transfer areas between clean room class A and class B.
- Control panels or access points (where operators can intervene or load components such as stoppers).
- Wherever there are open ampoules, vials and containers (e.g. at the exit of a sterilization tunnel).
- Where there are aseptic connections.
CLEANROOM MONITORING COMPONENTS
The "point-of-use" particle counters are usually permanently installed in the critical locations of a clean room and combined to form a system in order to continuously monitor the clean room for particles. The critical locations are evaluated by means of a risk analysis and regulations (EU-GMP Annex 1, PIC / S, FDA) apply.
Models with or without an internal vacuum pump allow the greatest possible flexibility in system design.
The measurements are visualized, monitored for limit values and saved in the clean room monitoring software. The data are available for later evaluations. Bakrona offers tailor-made solutions for the life science and electronics / semiconductor industry as well as for the healthcare sector.
Reports and graphics can be output manually or automatically. The systems conform to FDA 21 CFR Part 11 and GMP Annex 11.
MICROBIAL AIR SAMPLERS
Microbiological air samplers use an impactor head made of 316L stainless steel. The compact air samplers offer "plug-and-play" functionality and can be integrated into real-time monitoring systems.
Regardless of whether samples are taken in a clean room, a safety workbench or a laminar flow bank, the Remote ActiveCount fulfills the cGMP-compliant monitoring requirements.
PARTICLE COUNTERS AND AIR SAMPLERS
FOR CLEANROOM MONITORING
Apex R3 / R5
2 or 4 particle sizes
Particle sizes from 0.3 µm
Resistant to H2O2 / VHP
Ethernet, RS-485, POE, Modbus TCP, ASCII, RTU
Apex Rp with pump
2 or 4 particle sizes
Particle sizes from 0.3 µm
Built-in vacuum pump
Air outlet with HEPA filter
T/rH sensor can be connected
Up to 8 particle channels
Particle sizes from 0.1 µm
High flow 1.0 cfm
Meets ISO 21501-4 standard
MICROBIAL AIR SAMPLER
REMOTE Active Count
Permanently installed collecting heads
Uses external pump
Flow 1 CFM (28.3 LPM)
Counting efficiency ISO 14698-1
Collecting head 316L stainless steel
HOW CAN WE SUPPORT YOU WITH YOUR MONITORING REQUIREMENTS?