Cleanroom Validation

As a non-manufacturer of clean room facilities, our cleanroom/clean air cabinet performance reports can be considered as completely independent.           

We provide complete validation and certification solutions for all types of clean room and clean air cabinet/clean air workstation.        

Cleanroom Validation Reports

Our comprehensive validation report describes in detail the raw data acquired from our test results and measurements taken on site. Reports clearly identify whether or not a room or device meets the relevant standard. Our reports include plan drawings of all the areas surveyed, showing HEPA Filter locations, airborne particle count positions, differential pressures, recovery rate locations and other information appropriate to the validation. Copies of calibration certificates are also included in all reports.
 
 
We provide comprehensive documentation including all necessary SOP’s and method statements where requested. Each Clean Room facility has its own validation identity and test methods can vary in accordance with these. We therefore ensure that all of our method statements and standard operating procedures comply with the appropriate standards and the requirements of our clients.
 

Cleanroom Validation Tests

 
All work is performed to the following standards: BS EN 14644, EU GMP, Fed Std 209E, BS 5295 Our Cleanroom Validation services include:
  • Air volume flow rate and air change rate measurements
  • Air and room pressure differential measurement
  • HEPA filter integrity leak testing
  • Airborne particulate cleanliness counts
  • Pressure gauge calibration
  • Airflow visualisation studies
  • Recovery performance testing
  • Temperature and humidity monitoring
  • Lighting and noise level measurements
  • Containment leak testing

We also offer the following services:           

  •   UKAS Calibration of temperature monitoring systems
  •  Supply of Wireless Monitoring Solutions, temperature/humidity/pressure (dp) etc.

Cleanroom Validation Tests – Further details:

Air Volume Flow Rates        

  • Air volume flow rate readings are to ascertain the total volume flow rate serving a clean area. The air volume flow rates achieved are compared with design criteria (where available).
  • Air change rates for the controlled areas will be calculated and reported
  • Reference can also be made to the requirements and procedures detailed in BS EN ISO 14644-3 (2005).

Differential Pressure Measurements        

  • Independent pressure readings are taken to ascertain the difference in pressure between two areas, which confirms operator/product protection.
  • If a direct reading is not possible, the differential pressure gauge tubing will be used.
  • Reference can also be made to the requirements and procedures detailed in BS EN ISO 14644-3 (2005).

HEPA Filter Testing   

  • Particle challenge (filter integrity) leak tests are carried out on HEPA filters to prove that neither the HEPA filter nor its housing permits the bypass of particulate to a level which exceeds the acceptance criteria and could compromise cleanliness or particulate control.
  • HEPA filters are subjected to an artificial particulate challenge (DOP) and scanned to detect leaks.
  • The Downstream side of the HEPA filter (media, housing, frame and seal) is scanned in overlapping strokes using a photometer probe (at a scan rate not exceeding 5cm/sec) to ensure that no bypass greater than the acceptance criteria is evident.
  •  Where scan testing is not possible, volumetric sample efficiency (by duct traverse sampling) will be taken and these results are detailed as an overall volumetric efficiency.
  • Reference can also be made to the requirements and procedures detailed in BS EN ISO 14644-3 (2005). 

Particulate Monitoring   

  • Airborne particulate cleanliness tests are carried out to confirm the level of non-viable airborne particulate within the area under test and compare with the acceptable concentration levels for the class or grade of the area.
  • The number of sample locations and sample volume at each location is calculated and established. The Particle Counter instrument then counts and records the levels of particulate at each agreed sample location.
  • The particle count levels recorded, along with any statistical analysis (where applicable), are detailed on the individual printouts contained within our reports. Results are expressed in counts per cubic foot and also as concentration per cubic metre. Statistical analysis is expressed in concentration per cubic metre.
  • The considered particles size(s) for classification and statistical analysis are detailed in our reports.
  • Details of the requirements and procedures used are specified in BS EN ISO 14644-1 (1999).
  • For EU GMP Grade clean area requirements, the procedure specified in BS EN ISO 14644-1 (1999) will be used for calculating sample volumes and locations, using the nearest ISO whole number Classification as the class reference. However, EU GMP concentration limits will be the overriding acceptance criteria (where applicable). 

BS EN ISO 14644-1: 1999

CLASS Number of Particles per Cubic Meter by Micrometer Size
  0.1µm 0.2µm 0.3µm 0.5µm 1.0µm 5.0µm
ISO 1 10 2        
ISO 2 100 24 10 4    
ISO 3 1,000 237 102 35 8  
ISO 4 10,000 2,370 1,020 352 83  
ISO 5 100,000 23,700 10,200 3,520 832 29
ISO 6 1,000,000 237,000 102,000 35,200 8,320 293
ISO 7       352,000 83,200 2,930
ISO 8       3,520,000 832,000 29,300
ISO 9       35,200,000 8,320,000 293,000

EU GMP ANNEX 1 – MARCH 2009

EU GMP GRADE OF ENVIRONMENTAL CLEANLINESS MAXIMUM PERMITTED NUMBER OF PARTICLES PER CUBIC METRE
(equal to or greater than stated size)
  At rest   In Operation  
Grade 0.5µm 5.0µm 0.5µm 5.0µm
A 3,520 20 3520 20
B 3,520 29 352,000 2,900
C 352,000 2,900 3,520,000 29,000
D 3,520,000 29,000 Not defined Not defined

 

Differential Pressure Gauge Calibration     

  • Magnehelic/minihelic type pressure gauges are cross-check calibrated against a calibrated test instrument to ascertain the accuracy of the gauge.
  • The reference tubing is removed from the installed pressure gauge and the pressure gauge is zeroed.
  • Our test instrument is then connected to the Gauge’s reference tubing. Using this referencing pressure level connected to both the installed gauge and the independent test instrument, both pressure readings are recorded. The variation is also recorded and compared to the acceptable gauge tolerance. Multi point calibrations can also be performed where requested.
  • If the installed gauge calibration is adjusted then the before and after adjustment figures are recorded and presented in our report. 

Temperature & Relative Humidity Levels, Noise and light level   

  • Temperature and humidity, light and noise readings are taken to give a snap shot view of these environmental conditions at the time of testing.
  • Instruments are sited at specific locations within a facility, as previously agreed with the customer, and after a suitable stabilisation time has been allowed, measurements are taken.
  • Recordings are taken over at least a 1 minute period at each location, or more if requested by the client.
  • Reference can also be made to the requirements and procedures detailed in BS EN ISO 14644-3 (2005).