CALIBRATION VALIDATION

The flow rate of any air sampler should be periodically checked to evaluate that the volume of aspirated air is consistent.


There are two types of check to adopt:
• an “on site” monthly or quarterly quality control check to confirm continued performance and identify any irregularity, possibly caused by damage
• bi-annual or annual “official” calibration to re-validate the sampling rate and satisfy regulatory bodies that the instrument is operating correctly.


The “on site” Quality Control monitoring of the SAS (Surface Air System) Family of air samplers:
Impeller anemometer with LCD display for the routine evaluation of "SAS (Surface Air System)" air sampler performance
• Shows the air flow of any "SAS (Surface Air System)" microbiological air samplers
• Readings in either litres per minute (l/min) or cubic feet per minute (CFM)
• Just position it on top of the aspirating head of the air sampler and switch on
• Measuring time 30 seconds
• According to Good Laboratory Practice and Good Manufacturing Practice
• Standard Operating Procedure


The official calibration of the SAS (Surface Air System) family of air samplers:
Why and when you need air sampler validation?
It is important to verify that the volume of air you are sampling with your air sampler is correct to avoid errors in monitoring the contamination of an environment. Validation is an important step to assure that the final calculation is based on an accurately sampled volume of air. Validation of the aspirated volume should be performed every 6 months or 12 months. Re-validation is also recommended if the air sampler has potentially been damaged or the flow rate has been compromised.

"PYRAMID FLOWCHECK SYSTEM"
The new “PYRAMID” flowcheck is a new easy-to-use, battery operated system that is applied to calibrate all the air samplers of the “SAS” family.
This instrument is composed of two separate units, a fan and a flowmeter. The perfect balanced fan has a special rubidium-made bearings that generate an electromagnetic field proportional to the fan speed. The flowmeter measures this electromagnetic field and then calculates the exact air flow that is passing through the fan.
The “Pyramid” flowcheck system can display the airflow either in litres per minutes (L) or cubic feet per minute (CF).
The precision of the measured value is for “SAS Super 100” air sampler +/- 3 litres, for “SAS Super 180” air sampler +/- 4 litres.
The internal battery life is approximately 3 years under normal operative conditions.
Technical specification:
Weight:890 grams
Measurement range: 70-200 litres per minute
Suggested operational temperature: +20°C (+/- 2°C)
Power supply: 3V type CR2032 lithium battery. The normal battery life is 30.000 measurements of 60 seconds
Reading: The LCD display can show the results in litres per minutes (L) or cubic feet per minute (CFM).
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SERVICING
International PBI guarantees a comprehensive calibration and service program in its Milan (Italy) premises or through local authorized distributors.
The list of distributors trained for calibration and servicing is listed on the web www.internationalpbi.it (English Version) at calibration-validation chapter.

References of SAS - Surface Air System
FDA - 1987 Guideline on Sterile Drug Products by Aseptic Processing
ACGIH - Guideline for the Assesment of Bioaerosols in the indoor Enviroment
ASTM - Draft Protocol - Committee D22.05.06
USP (United State Pharmacopeia) - chapter <1116> - Microbiological Evaluation of Clean Rooms and other Controlled Environments
EU Guide for GMP - Manufacture of Sterile Medicinal Products Control of Medicines and Inspection