MicroBio Validation Kit
Operating Manual
Page 1: ...MicroBio Validation Kit Operating Manual ...
Page 2: ...tive 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 www cantiumscientific com February 2017 Rev 4 Printed in England ...
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Page 4: ...roduction 8 Kit Contents 9 Setting Up 10 Tube and head adaptor assembly 10 Preparing the air sampler 10 Validating the MB1 or MB2 bioaerosol sampler 11 Maintaining the Validation Kit 13 Additional Support 14 Calibration of the Validation Kit 15 Inspection Record 16 3 ...
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Page 6: ...n By Approved 1 First Issue 06 05 2009 SNJP DCP 2 Title modification Web link update Wording changes throughout document 04 11 2010 SNJP DCP 3 Updated to reflect new corporate logo 06 02 2015 SNJP DCP 4 Reformatting of manual 03 02 2017 SNJP DCP 5 ...
Page 7: ...RECTIVE 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 6 ...
Page 8: ...tributor who will arrange for repair of the instrument or if necessary a replacement This warranty does not cover accidental damage wear and tear consequential or incidental loss Damage caused by cleaning materials and methods not recommended by the manufacturer use beyond the specification use in wash down areas or modifications without prior permission from the manufacturer will invalidate the w...
Page 9: ...io samplers are working at peak performance requiring the minimum of training to use This guide provides information needed to validate the MicroBio MB1 and MB2 bioaerosol samplers and maintain the kit Instructional videos on how to use the equipment can also be found on our website by visiting https www cantiumscientific com products validation kit or visit our YouTube channel at www youtube com ...
Page 10: ...9M001 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 9 3 4 2 5 6 1 ...
Page 11: ...ation 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 Then place the validation rig on top of the MB1 or MB2 sampling head as shown in figure 3 Figure 3 Fitting validation rig to the MB1 MB2 bioaerosol sampler 10 ...
Page 12: ...ted 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 This will allow sufficient operating time for validation calibration to be performed Now start the sampler NOTE MB2 users will need to initiate sampling operation before fitting the validation rig to the MB2 sample...
Page 13: ... fails a second time the sampler should be returned to Cantium Scientific Limited or your local distributor for calibration It is possible for users to adjust the flow if required by turning the adjustment screw located as shown in figure 4 using the screwdriver supplied 5 The adjustments should always be made slowly Self adjusting will invalidate the calibration certificate provided with the samp...
Page 14: ...e the following checks 1 Ensure the orange coloured seals in the head adaptor 2 are clean secure and level 2 The calibrated flow tube 1 fits securely into the adaptor head 2 3 Looking into the bottom of the glass tube check the white PTFE stopper is in line with the direction of the tube and not at an angle restricting flow If not this can be moved into position using small pliers or tweezers 4 Th...
Page 15: ...tained 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 Or visit our website at https www cantiumscientific com support information 14 ...
Page 16: ... points on the tube scale and is compensated for on the flow markings on the tube The exact printing position on each tube is adjusted to take into account the equivalent true flow based on the known restrictions Once printed the tube is calibrated for life and no further adjustments are necessary Five year inspections will check the scale against the known restrictions using the same flow meter r...
Page 17: ...al Check Head Tube Fit OK PTFE Stoppers OK Glass Tube Fit OK 1 2 3 4 5 RETURN FOR 5 YEAR CALIBRATION 6 7 8 9 10 RETURN FOR 5 YEAR CALIBRATION 11 12 13 14 15 RETURN FOR 5 YEAR CALIBRATION 16 17 18 19 20 RETURN FOR 5 YEAR CALIBRATION 16 ...
Page 18: ...Cantium Scientific Limited MicroBio Validation Kit Operating Manual www cantiumscientific com February 2017 Rev 4 Article A 00133 ...
