Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

I would NEVER introduce a positive BI in your equipment EVER.  Bad idea for so many reasons that I can't list them all here.  That said, my first thought on this would always be to start with penny cylinders of the appropriate material as surrogates for your equipment and THAT is where I would introduce the positive BI strain(s) you want to check.  Prove that your process clears these organisms there and then bring the process out to your production floor and test pre- and post-cleaning/sanitizing.  In addition to bio-load issues, make sure you have some understanding of the possible additional chemical materials that might be found out in your plant and swab for those as well.  Obviously the swabbing for chemicals will need to be tested analytically and you will need to verify that they can be recovered from your swabs.

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Victor Mencarelli
Director - Regulatory Affairs
Hain Celestial Group
United States
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Original Message:
Sent: 28-Apr-2017 08:31
From: Anonymous Member
Subject: Cleaning validation

This message was posted by a user wishing to remain anonymous

What would you recommend to verify cleaning in a facility processing a pharmaceutical (antacid-primarily a calcium tablet) and other dietary supplements to meet FDA expectations? What type of swabs should be used? Would you introduce a positive BI? 

Would various verification be necessary on different metal surfaces? For example brass verses stainless?

Thank you for you time and assistance.

FDA expects that after cleaning of the piece of equipment, it should not carry over the residue on the next product. To show this company shows cleaning verification for dietary supplements (typically 1 batch) and cleaning validation for prescription products ( typically 3 batches).

You can use cotton swab or foam swab based on the maximum recovery of the API easily sourced from the VWR company or equivalent.

Usually cleaning of the equipment is carried out with water followed by 70% isopropyl alcohol and allow it to dry. So it does not require for microbiological study.

Compny has to consider all the metal surfaces that needs to studied based on the equipment. For example tablet press turn table is stainless steel and feed frames are brass. so you have to consider both for recovery. It would be part of your cleaning method validation that is suitable for cleaning verification.

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Gaurang Bhavsar
Edison NJ
United States
------------------------------

Original Message:
Sent: 28-Apr-2017 08:31
From: Anonymous Member
Subject: Cleaning validation

This message was posted by a user wishing to remain anonymous

What would you recommend to verify cleaning in a facility processing a pharmaceutical (antacid-primarily a calcium tablet) and other dietary supplements to meet FDA expectations? What type of swabs should be used? Would you introduce a positive BI? 

Would various verification be necessary on different metal surfaces? For example brass verses stainless?

Thank you for you time and assistance.

This message was posted by a user wishing to remain anonymous

Thank you.
Original Message:
Sent: 29-Apr-2017 10:09
From: Gaurang Bhavsar
Subject: Cleaning validation

FDA expects that after cleaning of the piece of equipment, it should not carry over the residue on the next product. To show this company shows cleaning verification for dietary supplements (typically 1 batch) and cleaning validation for prescription products ( typically 3 batches).

You can use cotton swab or foam swab based on the maximum recovery of the API easily sourced from the VWR company or equivalent.

Usually cleaning of the equipment is carried out with water followed by 70% isopropyl alcohol and allow it to dry. So it does not require for microbiological study.

Compny has to consider all the metal surfaces that needs to studied based on the equipment. For example tablet press turn table is stainless steel and feed frames are brass. so you have to consider both for recovery. It would be part of your cleaning method validation that is suitable for cleaning verification.

------------------------------
Gaurang Bhavsar
Edison NJ
United States
------------------------------

Original Message:
Sent: 28-Apr-2017 08:31
From: Anonymous Member
Subject: Cleaning validation

This message was posted by a user wishing to remain anonymous

What would you recommend to verify cleaning in a facility processing a pharmaceutical (antacid-primarily a calcium tablet) and other dietary supplements to meet FDA expectations? What type of swabs should be used? Would you introduce a positive BI? 

Would various verification be necessary on different metal surfaces? For example brass verses stainless?

Thank you for you time and assistance.

Hello,

here's an useful guidance for you question, ICH Q7.

Best Regards,

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Tyng-Yi (Tina) Lee MS RAC
Consultant
North Brunswick NJ
United States of America
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Original Message:
Sent: 30-Apr-2017 22:53
From: Anonymous Member
Subject: Cleaning validation

This message was posted by a user wishing to remain anonymous

Thank you.
Original Message:
Sent: 29-Apr-2017 10:09
From: Gaurang Bhavsar
Subject: Cleaning validation

FDA expects that after cleaning of the piece of equipment, it should not carry over the residue on the next product. To show this company shows cleaning verification for dietary supplements (typically 1 batch) and cleaning validation for prescription products ( typically 3 batches).

You can use cotton swab or foam swab based on the maximum recovery of the API easily sourced from the VWR company or equivalent.

Usually cleaning of the equipment is carried out with water followed by 70% isopropyl alcohol and allow it to dry. So it does not require for microbiological study.

Compny has to consider all the metal surfaces that needs to studied based on the equipment. For example tablet press turn table is stainless steel and feed frames are brass. so you have to consider both for recovery. It would be part of your cleaning method validation that is suitable for cleaning verification.

------------------------------
Gaurang Bhavsar
Edison NJ
United States
------------------------------

Original Message:
Sent: 28-Apr-2017 08:31
From: Anonymous Member
Subject: Cleaning validation

This message was posted by a user wishing to remain anonymous

What would you recommend to verify cleaning in a facility processing a pharmaceutical (antacid-primarily a calcium tablet) and other dietary supplements to meet FDA expectations? What type of swabs should be used? Would you introduce a positive BI? 

Would various verification be necessary on different metal surfaces? For example brass verses stainless?

Thank you for you time and assistance.