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           Pharmaceutical Cleanroom environmental monitoring sensors

 

A wide range of on line sensors for measuring temperature, humidity, airflow, pressure , differential pressure and particle counters for continuous clean room production and storage area monitoring and control. The sensors are complimented with Lufft data logging modules supported by FDA & 21CFR11 compliant software.

Lufft have extensive experience in providing measurement solutions in a variety of European class A & B pharmaceutical  clean room production facilities.

 

A quick summary of each instrument is given below, but if you need the full story, please request a copy of the product data sheet, either by phone (01767 692692), email, or use the Contact us link, filling in the details as required. Thank you.

 

 

Data Collection

 

Particle Counter (Pharmaceutical)


Counts particles in the 0.5 µm and 5.0 µm size range; separate pump
and sensor modules

Metone p/n 2195.00


Particle sizes 0.5 and 5.0 µm/1 cubic ft.


Coincidence loss 5 % at 400,000 particles/1 cubic ft.


Accessories
Differential pressure transducer, -1 … +1 bar, p/n 2194.1
Differential pressure transducer, -1 … +1 bar, p/n 2194.2
Vacuum pump VLT 25 p/n 2195.10
Bev-Line-Hose 1/4 "             p/n 2195.21
Vacuum hose 19 mm - 3/4 " p/n 2195.24
Vacuum hose 13 mm - 1/2 " p/n 2195.25
Branching for vacuum line,   p/n 2195.26
Power supply OPUS 200(i)/300(i)/208 p/n 8161.SV3
Power supply 6 VDC                            p/n 8160.SV6DC

 

 

 

Particle Counter (Pharmaceutical)
Counts particles in the 0.3µm and 0.5 µm size range; separate pump
and sensor modules

Metone p/n 2195.01


Particle sizes 0.3 and 0.5 µm/1 cubic ft.
Coincidence loss 5 % at 400,000 particles/1 cubic ft.


Accessories same as 2195.00


Particle Counter


Module with integrated pump and sensor for measurements at the workbench

P/n 2195.02


Channel sizes 0.3 and 0.5µ m/1 cubic ft.
Coincidence loss 5 % at 400,000 particles/1 cubic ft.

 
 Differential Pressure Sensor
  Pressure Sensor
 Flow Sensor
 Temperature & Humidity lufft Temperature/humidity sensor

 

Please contact us to discuss your measurement needs.    

 

 

Pharmaceutical Clean Room Classification

EU GGMP

The most recent set of standards for use in Europe came into operation on the 1st of January 1997. This is contained in a ‘Revision of the Annex to the EU Guide to Good Manufacturing Practice-Manufacture of Sterile Medicinal Products’. The following is an extract of the information in the standard that is relevant to the design of clean rooms:

For the manufacture of sterile medicinal products four grades are given. The airborne particulate classification for these grades is given in the following table:

Medicinal Cleanroom Classifications for particle count


5 Swan Lane, Sandy, Beds, SG19 1NE   
  Tel: (01767) 692692   Fax: (01767) 691831

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