cleaning validation

can anyone explain the most used cleaninig agent in pharmaceutical industries and why?

Dear Priyanka,

Please go through the forum of CLEANING VALIDATION.

With Best Regards,
Sudarshan Reddy
ys.sudarsan@gmail.com

Dear prianyka

In my opinion water is the the best cleaning agent,because if u use other agents for cleaning purposes like Teepol (which is used most commonly),the u have to do cleaning validation of Teepol also vendor qualification u have to do and also u have to ensure that every time teepol shall be purchased from same vendor and every time Certificate of Analysis has to be taken from particular vendor and it is very costly & time consuming.also u have to do method validation…

Now a days US FDA auditors r very keen in cleaning validation procedures specially if some firm is using Cleaning agents like Teepol then through documentation is must.

Thats why i prefer water is the best cleaning agent.

PRASAD APARAJIT
VALIDATION \NICHOLAS PIRAMAL.

SLS is one of the most commonly used cleaning agent, because it can be used safely in different concentrations. Even SLS is also used in product formulations.

Gnerally nonionic cleaning agents are preferable to inonic detergents. Ionic detergents are difficult to remove from the article surfaces.

Cleaning agents which are to be used for critical equipment cleaning should be comprise of known ingredients on which appropriate method of analysis can be developed. The LD50 value of that cleaning agent must be known. Using toxic, hazardaous meterials should be avoided.

[quote=Sambhu]SLS is one of the most commonly used cleaning agent, because it can be used safely in different concentrations. Even SLS is also used in product formulations.

Gnerally nonionic cleaning agents are preferable to inonic detergents. Ionic detergents are difficult to remove from the article surfaces.

Cleaning agents which are to be used for critical equipment cleaning should be comprise of known ingredients on which appropriate method of analysis can be developed. The LD50 value of that cleaning agent must be known. Using toxic, hazardaous meterials should be avoided.[/quote]

Dear Sambhu
Please read Post #6 on
http://www.askaboutvalidation.com/forum/showthread.php?t=241

[quote=Shahid Ali]Dear Sambhu
Please read Post #6 on
http://www.askaboutvalidation.com/forum/showthread.php?t=241
[/quote]

How would you validate the cleaning activity or effectivness of the cleaning agent used ?

Ok cool!!! First tell me what is the fate of cleaning Validation, My dear its an assurance that cleaning procedures are removing residues to predetermined levels of acceptability. These cleaning procedures may use suitable cleaning agent or in some cases hot water can be suffecient enough to clean out the residues. In fact in Cleaning validation only an API or Finished Products residue are never been in the scope, a product or an API can be contaminated by other pharmaceutical products, by cleaning agents, micro-organisms or by other material (e.g. air-borne particles, dust, lubricants). Further sources of contamination might be raw materials, intermediates, auxiliaries, etc. So all in all Cleaning validation assures over all effectiveness of cleaning procedures and Holding time as well.

Mr. Shahid is right

Thanks for the consent.

Chlorhexidine as it is a strong disinfectant:)

Chlorhexidine (is a chemical antiseptic. It kills (is bactericidal to) both gram-positive and gram-negative microbes, although it is less effective with some gram-negative microbes.It is also bacteriostatic. Products containing chlorhexidine in high concentrations must be kept away from eyes (corneal ulcers) and the inner ear (deafness).

Thanks

[SIZE=“7”]Mostly used cleanining agent in pharmaceutical industries is methanol [/size]

Though different pharmaceutical industries uses different cleaning agent, my opinion is to establish water as the most cleaning agent due to its wide availability and low cost. Additional treatment can be done like heating the water, increasing the contact time and cleaning cycle which can drastically change the efficiency of water as cleaning agent. Moreover, use of purified water (as a final rinse) can minimise the impurities that water could generate itself. However establishment of drying time and Clean Equipment Holding Time is important to control the microbial proliferation.

Prawan Dahal