REMOTE ACTIVE COUNT UNITS FOR INTEGRATION INTO CMRS

VIABLE* & NON-VIABLE PARTICLE SAMPLING SYSTEM

EXAMPLE SYSTEM DESIGN W/RACs & APCs

FUNCTIONAL SAMPLE DIAGRAM

INTRODUCTION ON VIABLE PARTICLE SAMPLING SYSTEM – COLONY FORMING UNITS MONITORING

Facility Monitoring System based pharma particle (non-viable) monitoring systems can easily be expanded with special validated RAC (Remote Active Count)

sampling heads in order to double use monitoring systems enabling both (sampling of particles and viable/germs.

(1) PROCEDURE

1. By microbiological RAC sampling heads a measurement gets started via the FMS pharma monitoring systems or via a remote start/stop control point.

2. The fixed sampling heads are mounted at the most critical GMP places which is often next to the remote APC’s isokinetic sampling probe (non-viable

sampling).

3. Ahead of starting the measurement cycle a nutrient surface (agar-plate) is placed in the 90 mm plate holder.

4. After starting the measurement, a flow measurement is activated by turning on a remote vacuum pump or a vacuum valve.

5. The measuring time can be preset via the FMS software between 1 minutes (minimum cycle = 28.3 LPM) to 240 minutes (extra-long cycle = 6.720 liters)

(2) TYPICAL APPLICATIONS

• Any Class A or Class B location such as:

Pharmaceutical Filling Lines,
Microbiological Safety Cabinets,
LAF cabinets,
Isolators,
Radiopharmaceutical Hot Cells,
Etc.

(3) PLACING OF REMOTE ACTIVE COUNT RAC / RAC VERSIONS

• The RAC can either be placed . . .

Right at the location were the microbiological sampling is done ❶ (often next to the remote APC’s isokinetic sampling probe) or
at a remote position using a suction funnel w/ isokinetic probe ❷

The remote switch can be used to activate the RAC from distance on chosen times.

It sends a start/stop signal and the indicator LEDs do indicate the status of the system (RAC-3 or Control Panel)

(4) RAC CONTROL PANEL

The RAC Control Panel takes care of the signals to the RAC. It can also be integrated in a monitoring system in combination with particle counters and environmental sensors.

(5) SOFTWARE FEATURES RELATED TO THE VIABLE MONITORING SYSTEM

• The Software controls/records Start/Stop and Data Logging of Viable Sampling such as:

Time / Data of Sample
Duration of Sample
Flow Rate of Sample
Total Flow Rate of Sample

FEATURES

- Compliant Life Cycle Documentation

- 21 CFR Part 11 Compliant

- Report Management

- Multi-level Access Permissions

- Audit Trails (User Access & Events)

- Flexible Open System Structure

- Non-viable & Viable Particles

- Easy User Navigation

- Secure Database

- Customizable Screens and Graphs

- Network able (Client-Server)

- Scalable (Small to Large Systems)

- Redundancy Capabilities (Option)

- Automatic Back-up (Option)
- Made in Germany

VIEW PRODUCT INFORMATION

Accessories

	MICROBIAL AIR SAMPLER REMOTE ACTIVE COUNT		MICROBIAL AIR SAMPLER REMOTE ACTIVE COUNT
	TOP AIR INTAKE FUNNEL FOR REMOTE SAMMPLING		SCOPE OF DELIVERY
	DIMENSIONS OF TRI CLAMP VACUUM CONNECTION		COVER FOR MICROBIAL AIR SAMPLER REMOTE ACTIVE RAC