Are we have to perform CV for Dispensing Booth( RLAF) / [COLOR=#000000]Dispensing ROOM , if yes what are the locations to swab/rinse[/color]
Hi,
Yes, based on the application / uses of dispensing booth the cleaning process validation can be performed. Approach remain same as in facility cleaning validation.
Normally swab from surface is taken in dispensing booth, but if you are including the sampling / cleaning aid validation in same protocol rinse also can be taken. Locations can be determined based on the difficult to clean area approach (Based on your unit setup).
Happy Reading 1
in dispensing there is no contable surface area of the product , then why we have to perform cleaning validation , if cleaning validation is performed what is the common equipment surface area
Dispensing will generate fine dust. That might eventually cause risk to operators and also products. One should have a cleaning process to prevent any cross contamination and product exposure.
Dispensing tools must be seperate. You cannot have a sperate LAF but scoops and other utensils must be seperate.
Its essential to clean dispensing area and validate.There is nothing wrong in concept when you have different products manufactured in facility.
Some companies do have different dispensing areas for different products. Not all small companies can maintain and build such areas. So cleaning concept is really important and catches regulators eyes.
Regulators will be keen in looking into this at the first instance.
Regards
Hi,
Good to see the opinion Mr. Reddy. Actually during dispensing booth validation we are validating the cleaning process effectiveness, to avoid cross contamination & contamination as well. Mr. Durga already explained dust generation concept…so unfortunately contact surface is in picture…even for dedicated dispensing booth there are cleaning processes being followed which normally do not needs to be validated but ofcourse verification part is must… !
Happy Reading !
It is true that dispensing generates dust, so does sifting and transfering into containers. How can we explain that the walls and ceiling are not considered during cleaning validation for chemical testing and limit calculations? They are only considered for environmental monitoring.
I disagree that dispensing booths should be included in the matrix (surface are taken into consideration) of equipment for cleaning validation.
Jay
The above is with respect to non sterile manufacture. For sterile you need to consider micro.
Jay
[quote=DURGA PRASAD]Dispensing will generate fine dust. That might eventually cause risk to operators and also products. One should have a cleaning process to prevent any cross contamination and product exposure.
Dispensing tools must be seperate. You cannot have a sperate LAF but scoops and other utensils must be seperate.
Its essential to clean dispensing area and validate.There is nothing wrong in concept when you have different products manufactured in facility.
Some companies do have different dispensing areas for different products. Not all small companies can maintain and build such areas. So cleaning concept is really important and catches regulators eyes.
Regulators will be keen in looking into this at the first instance.
Regards[/quote]
Hi Prasad,
Some regulators may insist that we validate isolator / dispensing booth cleaning; but how do you going about validating the cleaning method if you are only using manual cleaning as opposed to the big CIP systems where cleaning parameter control is available. Wouldn’t verification exercise suffice since the risk of product cross contamination is low since the facility is used mainly for operator protection and is indirect product contact. Have you got any experience where regulator is satisfied with the rationale that isolator / dispensing booth are indirect product contact, hence the use of manual cleaning (by operator) and verifying the cleanliness is acceptable.
Regards
Amateur
Regarding your question I would like to spilt them in to 2 categories.
I solators are very different in set up, containment levels and their operating parameters and the guidances required on these systems and places where they are exactly used. Isolator is a complex system where the cleaning should be done by CIP/SIP systems and you have specific and special mops with long handles to clean such systems. There should be a validated procedure to clean and analyse the system after cleaning operation. These guidances are stringent and it should be proved with documental evidence. No short cuts to say in general terms.
In the second system where there are dispensing booths manually some one can dispense. These booths will be stored in a seperate area where the entry and usage is also limited to specific staff. These are used for dispensing various products which are non-toxic for humans up to certain levels of inhalation exposure. Cytotoxics will always go in Isolators and some hormone products will also go in Isolators.After every dispensing procedure is complete, there is a standard procedure to clean such dispensing booths, take samples for validating the status of traces on the system or in the air comming out of the dispensing booths. Samples may be collected at intervals of 5min, 30 min, 45 min and after 1 hour during primary validation & evaluation studies. Once its proved that certain cleaning methodology is good it will be implemented as stanadard. The materails used for such tests will be powders, Hygroscopic powders, Liquids and semi solids depending up on the complexicity of manufacture. We always take a worst case and work to find out risks involved in cross contamination and OEL.
We faced auditiors and satified in the above systems.