Hello,
Is there any special feature in Sodium Lauryl Sulphate for using in Equipment Cleaning?
Today most of the pharmaceutical companies are using SLS as a cleaning agent. why?
Plz clarify to me.
Dear friend,
the main purpose of using Sodium Lauryl Sulphate as cleaning agent is it is a surfactant and some times used in formulations too. there are preset limits for surfactant as is same for drug products to control this to pass onto next product being manufactured,
what is the preset limit for sodium lauryl sulphate that can carry over to next product?
Sanjeev Setia
LD 50 for SLS is 1288 mg / kg
MACO of SLS = 128860SF*BS / MDD
Where as, 60 = Normal human body weight
SF = Safety Factor (for solid orals 1/100 to 1/1000)
BS = Smallest batch size of Product B
MDD = Maximum Daily Dose of Product B
U can calculate the limit for SLS thru this.
Dear all
Can we use teepol as cleaning agent …?
Anand Singh
Dear All
To my knowledge the critical control parameters for pharmaceutical process equipment cleaning include temperature, concentration and contact time of Cleaning agent Like temperature it is directly propotional to the cleaning of many pharmaceutical residues, secondly the concentration of cleaning agent higher concentrations enhance cleaning efficiency, they may also require more extensive rinsing volumes and time.
Actually SLS has been proven to emit toxic fumes on thermal decompositon, plus it is a known primery skin irretant and causes mild irritation on contact wid Skin and eyes. so it is quite not desirable as cleaning agent for pharmaceutical equipment from safety point of view. Infact SLS wud be expensive to be used as cleaning agent.
Regards,
Shahid Ali
QA Manager
Addis Pharmaceutical Factory SC, Ethiopia
[quote=Shahid Ali]Dear All
To my knowledge the critical control parameters for pharmaceutical process equipment cleaning include temperature, concentration and contact time of Cleaning agent Like temperature it is directly propotional to the cleaning of many pharmaceutical residues, secondly the concentration of cleaning agent higher concentrations enhance cleaning efficiency, they may also require more extensive rinsing volumes and time.
Actually SLS has been proven to emit toxic fumes on thermal decompositon, plus it is a known primery skin irretant and causes mild irritation on contact wid Skin and eyes. so it is quite not desirable as cleaning agent for pharmaceutical equipment from safety point of view. Infact SLS wud be expensive to be used as cleaning agent.
Regards,
Shahid Ali
QA Manager
Addis Pharmaceutical Factory SC, Ethiopia[/quote]
Dear Shahid,
What you are saying is true.
But, using of cleaning agents for cleaning the equipments is not desirable, as those are not the part of process. Hence, we need to delevop the cleaning procedure without any cleaning agent.
Even Regulatory Agencies (USFDA, MHRA, etc.) are emphasing to avoid the usage of any cleaning agent, as part of cleaning procedure.
In any case, it is must for removing the residues, we need to have the TOXICITY DATA for this. And at the same time, we need to set the limit for cleaning agent.
So, before going for cleaning validation, we have to develop the cleaning procedure, to avoid such type of issues.
With Best Regards,
Sudarshan Reddy
ys.sudarsan@gmail.com
Well well well!!! I have gone through the guidelines i did not find such recommendations from USDA/ FDA/ MHRA typically not to use any cleaning agents, if you could come up with some reference it would be good for all. Obviously for the equipments used in manufacturing of oily products, Emulsions, Suspensions, Creams, Ointments and fatty ointments etc etc one can not simply use water or cleaning procedure without a suitable cleaning agents. Yes ideally a cleaning agent or surface treating agent should be suitable for critical cleaning application requiring a residue free surface. After rinsing, no residue remains on the surface. Semiconductor, optics, pharmaceutical, medical or biotech applications often require critical or residue free cleaning agent.
Dear Shahid,
Herewith I am giving some of the references…plz go through
USFDA - Guide to Inspections Validation of Cleaning Process
Detergent section
CANADA - HPFBI - Cleaning validation guidelines
4.9, 9.7 & 9.8
APIC - Cleaning validation in APIs
4.22 & 8.7
With Best Regards,
Sudarshan Reddy
ys.sudarsan@gmail.com
Dear Shahid Ali,
Please go through the below statement…
Know Product Ingredients and Intended Use of the Final Product
Previous to designing the cleaning procedures, it is necessary to know all physical and chemical characteristics of the product ingredients. Characteristics such as appearance, solubility, potency, and toxicity play an important part in the design strategy of a cleaning validation program. These characteristics will indicate whether solvents or detergents are needed for removal of product residues. Avoid the use of detergents or solvents whenever possible because their use demands added controls.
It is given by one of our Admin…in this forum of Cleaning Validation on 29/01/2007…“Equipment Cleaning Validation Within a Multi-Product Manufacturing Facility Part 1”.
With Best Regards,
Sudarshan Reddy
ys.sudarsan@gmail.com
Sudharshan,
No regulatory authority mentions that the use of the deteregent should be avoided.
Please find below the comments made in GUIDE TO INSPECTIONS VALIDATION OF CLEANING PROCESSES for DETERGENTS:
If a detergent or soap is used for cleaning, determine and consider the difficulty that may arise when attempting to test for residues. A common problem associated with detergent use is its composition. Many detergent suppliers will not provide specific composition, which makes it difficult for the user to evaluate residues. As with product residues, it is important and it is expected that the manufacturer evaluate the efficiency of the cleaning process for the removal of residues. However, unlike product residues, it is expected that no (or for ultra sensitive analytical test methods - very low) detergent levels remain after cleaning. Detergents are not part of the manufacturing process and are only added to facilitate cleaning during the cleaning process. Thus, they should be easily removable. Otherwise, a different detergent should be selected.
It clearly mentions that IT IS IMPORTANT TO SELECT THE RIGHT DETEREGENT which would help you in qualifying the cleaning process which includes:
1.Detection of detergent residue using validated analytical method.
2.Calculation of acceptable limits for detergent and
3.Most important your detergent should be free rinsing
It also specifies that, SINCE DETERGENTS ARE NOT THE PART OF THE PROCESS IT SHOULD BE CLEANED TO MIN. LEVEL POSSIBLE which means that a detergent need to be free rinsing.
The whole idea at the end of the day is to have least amount of turn around time and cleaning should be effecient. The regulatory agencies do not care if you use a detergent or not.But however it would be difficult to clean equipments which has products with low solubility. In India people can get away with using solvent and but in the regulated markets it is difficult to do so and thats the reason you see more and more aqueous cleaning agents being used.
[quote=Dharani]Sudharshan,
No regulatory authority mentions that the use of the deteregent should be avoided.
Please find below the comments made in GUIDE TO INSPECTIONS VALIDATION OF CLEANING PROCESSES for DETERGENTS:
If a detergent or soap is used for cleaning, determine and consider the difficulty that may arise when attempting to test for residues. A common problem associated with detergent use is its composition. Many detergent suppliers will not provide specific composition, which makes it difficult for the user to evaluate residues. As with product residues, it is important and it is expected that the manufacturer evaluate the efficiency of the cleaning process for the removal of residues. However, unlike product residues, it is expected that no (or for ultra sensitive analytical test methods - very low) detergent levels remain after cleaning. Detergents are not part of the manufacturing process and are only added to facilitate cleaning during the cleaning process. Thus, they should be easily removable. Otherwise, a different detergent should be selected.
It clearly mentions that IT IS IMPORTANT TO SELECT THE RIGHT DETEREGENT which would help you in qualifying the cleaning process which includes:
1.Detection of detergent residue using validated analytical method.
2.Calculation of acceptable limits for detergent and
3.Most important your detergent should be free rinsing
It also specifies that, SINCE DETERGENTS ARE NOT THE PART OF THE PROCESS IT SHOULD BE CLEANED TO MIN. LEVEL POSSIBLE which means that a detergent need to be free rinsing.
The whole idea at the end of the day is to have least amount of turn around time and cleaning should be effecient. The regulatory agencies do not care if you use a detergent or not.But however it would be difficult to clean equipments which has products with low solubility. In India people can get away with using solvent and but in the regulated markets it is difficult to do so and thats the reason you see more and more aqueous cleaning agents being used.[/quote]
Dharani,
If you want to take risk, by using the DETERGENT / CLEANING AGENT, that is upto you only.
As per my experience, Regulatory agencies (USFDA, MHRA) are more insisting the details of TOXICITY DATA OF THAT DETERGET, which is not so easy to get. Even in case of TEEPOL also, you find the same difficulty.
Moreover, you need to have the validation of finding that detergent and even the manufacturer is not providing any data on Toxicity.
And setting the limit for Detergent is very difficult and you can apply MACO for this without having proper data, like EMPERICAL FACTOR.
With Best Regards,
Sudarshan Reddy
ys.sudarsan@gmail.com
[quote=ys.sudarsan]Dear Shahid,
Herewith I am giving some of the references…plz go through
USFDA - Guide to Inspections Validation of Cleaning Process
Detergent section
CANADA - HPFBI - Cleaning validation guidelines
4.9, 9.7 & 9.8
APIC - Cleaning validation in APIs
4.22 & 8.7
With Best Regards,
Sudarshan Reddy
ys.sudarsan@gmail.com[/quote]
Dear Sudarshan
Please send the links for these references. I m quite unable to go through these references.
I want to use sodium lauryl sulphate as cleaning agent. However, I have just known sodium lauryl sulphate’s assay method on BP. I think it is difficult to assay residue. Would you like give me another assay method? Thank you so much!
If we are using SLS as a Cleaning agent then what could be the best analytical method to determinte residues of SLS?
Hi all
I would like to share to you that before going for the detergent whatever it may, it is advisable to check the cleaning efficiency without using detergent in the worstcase product, for eg. insoluble in water. If the study fails, we can
revise the standard cleaning procedures by incorporating the additional quantity of solvents to remove the residues in the equipment surface.
Regds
V.Saravana Kumar
Senior Validation Executive
Orchid Healthcare
Chennai
Do you have an answer about the method of analysis if we used SLS