Discontinued use of UV light in Dynamic passbox

Production
1

in sterile formulation facility it is recommended that discontinue use of UV light in Dynamic pass-box. I want to know the rational/reason.

2

@vaibhav where is it recommended?

3

i am also searching the document reference, in one of the USFDA inspection suggestion given as UV efficiency as antimicrobial in air media is questionable and don’t have sufficient study to challenge the same. UV we are using as surface sanitizer but there is no fixed hold period recommended anywhere. second reason we claim and monitor DPB as A grade so we are exposuring UV on micro settle plate for 4 hrs. this will give us the false positive or negative results. kindly put this into discussion and get it best practice.

4

Expose time for UV is subject of validation. After validation you can decide the time.

5

we have done study on different type of material and/or articles to establish expose time, the observation reveals that 1. There is no consistent results 2. articles with surface disinfectant before exposing to UV and after exposing at 15 min, 30 min same results observed. 3. for dirty article no major impact on bioload reduction.

In guideline also no where recommendation given for use of UV in Pass-box.

I want to know is any strong requirement?, to monitor grade A environment in pass-box by means of micro settle plate (passive sampling).

I want to know the global practice, so we will implement the best industrial practice.

6

Generally companies are not exposing plates in pass boxes but in some cases FDA inspectors recommend to do the same. These are extra precautionary measures that you can follow. Same is in the case of UV light in dynamic pass boxes.

7

Dear Vaibhav,

so far i know, The UV efficiency of a pass box is tested using the microbiological challenge test, which is carried out simulating exactly the real operative condition. For this test Bacillus subtilis is usually used as a challenge microorganism.

Basically, this test consists of the exposure of Petri dishes with culture medium, which is inoculated with a certain concentration of Bacillus subtilis . These plates are then exposed to UV radiation for the time determined by a validation study of UV inactivation.

Thanks

8

I have read that UV has 2 disadvantages:

  1. It is not a validated sporicidal agent

  2. The surface to be disinfected it must be “directly” exposed to radiation source and this is not achievable in the “whole” surface of items to be disinfected

The scientifically correct options are either VHP decontamination chamber or wiping with validated liquid sporicidal agent

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