Cleaning Validation of Heparin Sodium

GOOD VALIDATION PRACTICE (cGVP) CLEANING VALIDATION
1

Dear All,

Can anyone mention me about the impact of measuring TOC during cleaning validation of Heparin Sodium? If so what is the accpetance criteria or Maximum Carryover Limit?

Does TOC really have the impact on Cleaning Valdiation? How to anaylze the TOC level during cleaning valudation of Heparin Sodium?

Please do mention if any relevant articles or guideline for the above said issue.

Thanking You & Regards,

kvkiran

2

[quote=kvkiran]Dear All,

Can anyone mention me about the impact of measuring TOC during cleaning validation of Heparin Sodium? If so what is the accpetance criteria or Maximum Carryover Limit?

Does TOC really have the impact on Cleaning Valdiation? How to anaylze the TOC level during cleaning valudation of Heparin Sodium?

Please do mention if any relevant articles or guideline for the above said issue.

Thanking You & Regards,

kvkiran[/quote]

Dear Kiran,
TOC is an alternate technique for Clv studies,It is non specific technique, same procedure is apply for determination MAC, using standard.
Yes it is true, TOC really have impact on Clv studies.

Thanks

3

Thank You for your information.

I got something more thing to get clarify.

How to anaylze and measure TOC level during Clv of Heparin Sodium?

What is the corelation between TOC and Residue if obtained from Clv sample?

Can u please be specific about the imapct of TOC on Clv?

Thanking You & Regards,

kvkiran

4

[quote=kvkiran]Thank You for your information.

I got something more thing to get clarify.

How to anaylze and measure TOC level during Clv of Heparin Sodium?

What is the corelation between TOC and Residue if obtained from Clv sample?

Can u please be specific about the imapct of TOC on Clv?

Thanking You & Regards,

kvkiran[/quote]

Dear as you are more and more emphasizing on Heparin sodium, it seems all u have got a dedicated mfg facility for that, if i m not wrong. Anyways As above described TOC is a non specific technique for the analysis and infact it has a lot of advantages over specific techniques. But it doesnt mean that u are abide by Specific techniques as u are dealing with Heparin sodium, infact TOC will do more good for the analysis of CLV samples.

5

[quote=kvkiran]Thank You for your information.

I got something more thing to get clarify.

How to anaylze and measure TOC level during Clv of Heparin Sodium?

What is the corelation between TOC and Residue if obtained from Clv sample?

Can u please be specific about the imapct of TOC on Clv?

Thanking You & Regards,

kvkiran[/quote]

Hi Kiran,
Analysis on TOC is very simple, use blank, standard and sample and appropaite diluent, there is no corellation between HPLC and TOC technique b/c in HPLC we targeted specific analyte and not considering the other species like detergents and other excipients but in TOC its evalutae the whole.

6

Thank You Mr.Shahid Ali and Shanawaz for your information.

Regards,

kvkiran