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Summary of Contents for Cantium Scientific P0059
- Page 1 MicroBio Validation Kit Operating Manual...
- Page 2 MicroBio Validation Kit Model No. P0059 Operating Manual This work is licensed under a Creative Commons Attribution, Non-Commercial, ShareAlike 4.0 International License. https://creativecommons.org/licenses/by-nc-sa/4.0/ Cantium Scientific Limited Clarendon Gardens Dartford Kent DA2 6EY United Kingdom Tel: +44 (0) 1322 252000 ...
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Page 4: Table Of Contents
Contents Document Issue Statement of Conformity Warranty Introduction Kit Contents Setting Up Tube and head adaptor assembly Preparing the air sampler Validating the MB1 or MB2 bioaerosol sampler Maintaining the Validation Kit Additional Support Calibration of the Validation Kit Inspection Record... - Page 5 This page is left intentionally blank...
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Page 6: Document Issue
Document Issue Issue Description Date Revision Approved First Issue. 06/05/2009 SNJP Title modification. Web link update. 04/11/2010 SNJP Wording changes throughout document. Updated to reflect new 06/02/2015 SNJP corporate logo. Reformatting of manual. 03/02/2017 SNJP... -
Page 7: Statement Of Conformity
Statement of Conformity We certify that this product complies with EEC DIRECTIVE 2002/95/ EC the restriction of hazardous substances; commonly known as the RoHS directive. The validation kit is designed and manufactured under strict management systems compliant with ISO9001:2008 and calibration of the instruments is traceable to national standards. -
Page 8: Warranty
Warranty The manufacturer warrants this product to be free from defects in materials and workmanship for 24 months from the date of purchase. If your product is found to be defective within that period, please contact Cantium Scientific Limited or your local distributor who will arrange for repair of the instrument, or if necessary a replacement. -
Page 9: Introduction
Introduction The MicroBio Validation Kit is the standard device used to validate standard 100 litre per minute MicroBio MB1 and MB2 bioaerosol samplers. It provides a simple and cost effective method to ensure the MicroBio samplers are working at peak performance, requiring the minimum of training to use. -
Page 10: Kit Contents
Kit Contents 1. Calibrated flow tube (Part no. P0059M001) 2. Sampling head adaptor (Part no. 0059M002) 3. Contact plate 4. Petri dish 5. Trimmer screwdriver 6. Padded plastic carry case 7. User Guide (not shown in picture) 8. Factory calibration certificate (not shown in picture) Figure 1: Kit Contents... -
Page 11: Setting Up
Setting Up Tube and head adaptor assembly The first step is to insert the calibrated flow tube (1) into the head adaptor (2), as shown in figure 2. This forms the validation rig. Figure 2: Tube and head adaptor assembly Preparing the air sampler Fit the supplied Petri dish (4) or contact plate (3) into the MB1 or MB2 bioaerosol sampler to be validated and fit the sampling head. -
Page 12: Validating The Mb1 Or Mb2 Bioaerosol Sampler
Validating the MB1 or MB2 bioaerosol sampler Calibration and validation should be carried out in a controlled environment and on a level surface. Air movement around the calibration zone should be eliminated and ideally carried out in normal atmospheric pressure of 1013 mbar at 20°C. Figure 4: Location of adjustment screw hole Switch on the air sampler and set to take a volume of 400 litres. - Page 13 The float will rise in the validation rig. Hold the validation rig down firmly onto the MicroBio sampling head or alternatively use quick grip clamps (not supplied) to hold in place. The float should centre on the circle printed on the glass tube indicating a flow rate of 100 litres per minute.
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Page 14: Maintaining The Validation Kit
Maintaining the Validation Kit Due to the nature of variable area flow meters, as used in the validation kit and the product being manufactured to precise standards, annual calibration is not required. Regular inspection is needed. It is recommended that the validation kit is returned to Cantium Scientific Limited or an appointed re-seller for full factory inspection every five years. -
Page 15: Additional Support
Additional Support Further support for using the validation kit and the MicroBio MB1 and MB2 bioaerosol samplers can be obtained from Cantium Scientific Limited or your local distributor. Documentation to support IQ/OQ/PQ for use within pharmaceutical and related industries is available upon request by contacting Cantium Scientific Limited or your local distributor. -
Page 16: Calibration Of The Validation Kit
Calibration of the Validation Kit Calibration of the validation kit shall only be undertaken by Cantium Scientific Limited. It is recommended this is done at five yearly intervals. Variable area flow meters impose a restriction on air flow. This will cause a reduction in the normal flow of air through the MB1 and MB2 bioaerosol samplers. -
Page 17: Inspection Record
Inspection Record Year Date Seal Head/ PTFE Glass Check Tube Stoppers Tube Fit Fit OK RETURN FOR 5 YEAR CALIBRATION RETURN FOR 5 YEAR CALIBRATION RETURN FOR 5 YEAR CALIBRATION RETURN FOR 5 YEAR CALIBRATION... - Page 18 Cantium Scientific Limited MicroBio Validation Kit Operating Manual www.cantiumscientific.com February 2017 (Rev. 4) Article #A-00133...