Home › Forums › Infexion Connexion › Re: ‘micro testing in hepa filtration in ot
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27/08/2019 at 3:43 pm #75754Michael WishartParticipant
Author:
Michael WishartEmail:
Michael.Wishart@svha.org.auOrganisation:
State:
NSWHi Jayne
Particle counts and micro sampling are not the same. This is form a Particle counter vendor website, about the Standard for clean rooms:
Is the ISO 14644-2 also considering the microbial monitoring?
ISO 14644 do not specifically talk about microbial contamination, but takes only care of particles. Anyway, microbial contamination must be controlled as well during production using appropriate monitoring tools. You can find additional details in the EU-GMP Annex 1, FDA cGMP and ISO 14698.Cheers
MichaelMichael Wishart | Infection Control Coordinator, CICP-E
St Vincent’s Private Hospital Northside | 627 Rode Road CHERMSIDE QLD 4032
T +61 7 3326 3068 | F +61 7 3607 2226
E michael.wishart@svha.org.au |
W https://www.svphn.org.au[cid:image001.jpg@01D46C86.4CDB6090]
[2019 conference email signature]Thanks Terry,
By particulate counts I am assuming you mean air sampling?Jayne O’Connor RN ,BSc.,Inf.Cont
IPC Co-Ordinator
Sydney Adventist Hospital | 185 Fox Valley Road, Wahroonga, NSW 2076p: +61 2 9487 9732 | f: +61 2 9473 8052 | m: +61 0406 752685 | e: jayne.oconnor@sah.org.au
http://www.sah.org.au[SAH_EntitySignature2017][cid:image002.png@01D55CEC.B95859B0]
Hi Jayne,
Every year your HEPA filters should undergo an integrity test, the flow velocity should be checked as should the number of air changes per hour, [ideally] a particulate count [ORs are usually specified to meet a Class 8 clean room standard or better] and the pressure differentials across doorways into the OR checked. These tests hould also be performed in other areas where HEPA filters are located.
This resource is ageing now, but still well worth a read.
https://www2.health.vic.gov.au/Api/downloadmedia/%7B7C0364A2-A34D-4088-99F9-77FF0A818AF3%7D
Kind Regards
Terry McAuley
Director
MSc Medical Device DecontaminationPO BOX 2249, Greenvale VIC Australia 3059
[cid:image001.png@01D55CEB.22915F00]
I endeavour to achieve a sensible work-life balance: There is no need to reply to this email from you outside of your normal working hours. Please expect the same from me.
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Hi Brains trust,
We are in the middle of accreditation this week and a question regarding to ‘micro’ testing of hepa filters in theatres was asked by one of the auditors to our maintenance team, IPC have the same auditor tomorrow so we may also get the same question??
Does anyone have any information regarding whether we should be air sampling for example, frequency of the testing, to ensure the Hepa filters are working. We have a maintenance schedule for the them, but the only time we have done air sampling or micro is on commissioning of new theatres. I am not aware that micro sampling is done routinely or is a requirement??Many thanks inadvance
Jayne O’Connor RN ,BSc.,Inf.Cont
IPC Co-Ordinator
Sydney Adventist Hospital | 185 Fox Valley Road, Wahroonga, NSW 2076p: +61 2 9487 9732 | f: +61 2 9473 8052 | m: +61 0406 752685 | e: jayne.oconnor@sah.org.au
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27/08/2019 at 3:48 pm #75755Hi Michael,
I will know whether they were talking about micro testing or the particulate testing tomorrow, if they ask me, but thanks for clarifyingJayne O’Connor RN ,BSc.,Inf.Cont
IPC Co-Ordinator
Sydney Adventist Hospital | 185 Fox Valley Road, Wahroonga, NSW 2076p: +61 2 9487 9732 | f: +61 2 9473 8052 | m: +61 0406 752685 | e: jayne.oconnor@sah.org.au
http://www.sah.org.au[SAH_EntitySignature2017][cid:image002.png@01D55CEE.D4029AD0]
Hi Jayne
Particle counts and micro sampling are not the same. This is form a Particle counter vendor website, about the Standard for clean rooms:
Is the ISO 14644-2 also considering the microbial monitoring?
ISO 14644 do not specifically talk about microbial contamination, but takes only care of particles. Anyway, microbial contamination must be controlled as well during production using appropriate monitoring tools. You can find additional details in the EU-GMP Annex 1, FDA cGMP and ISO 14698.Cheers
MichaelMichael Wishart | Infection Control Coordinator, CICP-E
St Vincent’s Private Hospital Northside | 627 Rode Road CHERMSIDE QLD 4032
T +61 7 3326 3068 | F +61 7 3607 2226
E michael.wishart@svha.org.au |
W https://www.svphn.org.au[cid:image001.jpg@01D46C86.4CDB6090]
[2019 conference email signature]Thanks Terry,
By particulate counts I am assuming you mean air sampling?Jayne O’Connor RN ,BSc.,Inf.Cont
IPC Co-Ordinator
Sydney Adventist Hospital | 185 Fox Valley Road, Wahroonga, NSW 2076p: +61 2 9487 9732 | f: +61 2 9473 8052 | m: +61 0406 752685 | e: jayne.oconnor@sah.org.au
http://www.sah.org.au[SAH_EntitySignature2017][cid:image002.png@01D55CEC.B95859B0]
Hi Jayne,
Every year your HEPA filters should undergo an integrity test, the flow velocity should be checked as should the number of air changes per hour, [ideally] a particulate count [ORs are usually specified to meet a Class 8 clean room standard or better] and the pressure differentials across doorways into the OR checked. These tests hould also be performed in other areas where HEPA filters are located.
This resource is ageing now, but still well worth a read.
https://www2.health.vic.gov.au/Api/downloadmedia/%7B7C0364A2-A34D-4088-99F9-77FF0A818AF3%7D
Kind Regards
Terry McAuley
Director
MSc Medical Device DecontaminationPO BOX 2249, Greenvale VIC Australia 3059
[cid:image001.png@01D55CEB.22915F00]
I endeavour to achieve a sensible work-life balance: There is no need to reply to this email from you outside of your normal working hours. Please expect the same from me.
CONFIDENTIAL COMMUNICATION: The information contained in this message may contain confidential information intended only for the use of the individual or entity named above. If the reader of this message is not the intended recipient, you are hereby notified that any dissemination, distribution or duplication of this transmission is strictly prohibited. If you have received this communication in error, please notify us by telephone or email immediately and return the original message to us or destroy all printed and electronic copies. Nothing in this transmission constitutes an agreement of any kind unless otherwise expressly indicated.
Hi Brains trust,
We are in the middle of accreditation this week and a question regarding to ‘micro’ testing of hepa filters in theatres was asked by one of the auditors to our maintenance team, IPC have the same auditor tomorrow so we may also get the same question??
Does anyone have any information regarding whether we should be air sampling for example, frequency of the testing, to ensure the Hepa filters are working. We have a maintenance schedule for the them, but the only time we have done air sampling or micro is on commissioning of new theatres. I am not aware that micro sampling is done routinely or is a requirement??Many thanks inadvance
Jayne O’Connor RN ,BSc.,Inf.Cont
IPC Co-Ordinator
Sydney Adventist Hospital | 185 Fox Valley Road, Wahroonga, NSW 2076p: +61 2 9487 9732 | f: +61 2 9473 8052 | m: +61 0406 752685 | e: jayne.oconnor@sah.org.au
http://www.sah.org.au[SAH_EntitySignature2017][cid:image003.png@01D55CE8.455DF050]
If you are not the intended recipient you are hereby notified that any dissemination, distribution or reproduction of this message
is prohibited. If you have received this message in error please notify the sender immediately, then destroy the original message.
Any views expressed in this message are solely those of the individual sender, except where the sender is specifically authorised
by Adventist HealthCare Limited to state that they are the views of Adventist HealthCare Limited.
_____________________________________________________________________
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_____________________________________________________________________
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_____________________________________________________________________
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