freeze-drier cleaning

[mariannaliburdi]

can somebody tell me how to apporach to the cleaning validation of the freeze-drier?should I consider all the products that are lyophilized in order to calculate the limit for swab? in this case, have I to consider the surface of the chamber for the calculation? or this type of equipment can be considered as not at direct contact? is there any references to the guidelines that talk about this aspect?than you for your support!

[ramyaraj725]

since product cannot touch any part of lyophilizer directly, you can consider it as non-contact equipment and enough to clean upto visually clean state.

Regards
Veerraju

[DURGA PRASAD]

Professionals often have a misconception and think that the lyophilizer is a non-contact part.
In reality and as per regulatory compliance the whole lyophilizer is a contact part based on its operating conditions and movement of various trays, rubber stoppering systems and automation with in Lyophilizer.

If we have a spillage and lyophilize any other batch with out cleaning, the spillage will eventually dry out and due to vaccum conditions the falkes of these previous spills might enter the product under consideration.

FDA looks keenly into cleaning of such lyophilizers where end products are rendered stable by application of vaccum, heating and or cooling below subzero temperatures.

One must thoroughly clean and validate a lyophilizer.This is a critical point where the product quality might be compromized.

Regards

[DURGA PRASAD]

Technically no, but items that can come into contact with the product, e.g.aerating gases, result in the freeze dryer being accepted as a contact part.
Calculation:
1/1000 of minimum therapeutic dose in unit dose of next product
( swab area contamination * FD surface area / no of vials per batch)

[mariannaliburdi]

thank you for your point of view. when you talk about regulatory compliance do you make reference to a specific guidelines?
if yes, could you be so kind to tell me the references?
I am quite sure that the lyo has to be validated from a cleaning point of view, but the
problem is the limit calculation. if I consider the surfaces of the lyo shelves that could potentially be contamianted I often have very low limits.
when you talk about the formula:

1/1000 of minimum therapeutic dose in unit dose of next product
( swab area contamination * FD surface area / no of vials per batch)

what do you mean with FD surface area?
thank you for your help.

Professionals often have a misconception and think that the lyophilizer is a non-contact part.
In reality and as per regulatory compliance the whole lyophilizer is a contact part based on its operating conditions and movement of various trays, rubber stoppering systems and automation with in Lyophilizer.

If we have a spillage and lyophilize any other batch with out cleaning, the spillage will eventually dry out and due to vaccum conditions the falkes of these previous spills might enter the product under consideration.

FDA looks keenly into cleaning of such lyophilizers where end products are rendered stable by application of vaccum, heating and or cooling below subzero temperatures.

One must thoroughly clean and validate a lyophilizer.This is a critical point where the product quality might be compromized.

Regards

[DURGA PRASAD]

FD= Freeze Drier (Lyophiliser)
http://www.fda.gov/ICECI/Inspections.../ucm074909.htm

[DURGA PRASAD]

There is another way to clean lyophilizers.
First find out if the product of interest is soluble in 70% or 99% of IPA(iso propyl alcohol).
If it is soluble, you can take a clean wipe and clean the surface area of the Lyophiliser with that Wipe.
Incase if it is not soluble the last resort is CIP/SIP. Then it is compulsory to perform a CIP/SIP cycle and validate that.
Regards