Dynamic pass box- Functional Requirement

GOOD DOCUMENTATION PRACTICE (GDocP) FDS (FUNCTIONAL DESIGN SPECIFICATION)
#1

Dynamic pass box need to be installed between two different classified area/rooms for material pass through. The purpose is to provide barrier between areas & to sweep away the particulate load if present on surface of object being transferred to more clean area.
I) Is there any specific requirement of air velocity for pass box?
II) Whether blower is expected to remain ‘ON’ always irrespective of material transfer?
III) Is there any requirement about air flow movement either from pass box to area or vice a versa while door is open? (In case there is no fresh air port)

I would like to have your opinion with guideline reference if possible.
Best Regards
Ravi Dhanbhar

#2

There is no any specific requirement for air velocity for DPB.Air velocity shall be 0.45m/s i.e same as that of LAF.
Blower shall be always on condition.
Air from less clean area must not pass to more clean area.
Both doors shall not open at the sametime.There must interlocking for the same.

#3

Hi,

Just to add one query…is it require to validate / qualify all pass boxes [irrespective of application] or we have to assess the risk / applicability…

#4

Pass boxes acts as barriers between 2 classified areas. They might be used for material transfer either directly into manufacturing zones for further processing like Blending, Mixing, Sieving, process cleaning and or sterilization. These passboxes also aid in packing areas and also transferring used equipment parts and utensils out of classified areas.

In such casses essentially these are used as temporary barriers. They must be Validated and documented for their efficiency.What ever the Industry you are working (Starting from Orgal solids to Oral powders to Semisolids to Injectable to Oncology products to Biologicals), all such Pass boxes must be Qualified/Validated for suitability of their application and working.

#5

Mr Durga Prasad
give me an advice…
during a PQ study of that kind of equipment how can perfrom the microbiological sampling of air and on surface. I refer particulary to the surface of element that i put inside the box from the less clean zone…i have to sampling tha surface but that surface are not clean (probly) becouse they passes inside a dirt zone…how can i approch to PQ of Pass Through Box…

#6

I appreciate the job of system administrator who allows such dirty posts.

#7

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#8

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#9

Iam sorry for a delayed response.I missed this post some how.
When you carry PQ you must always have a SOP for cleaning the pass box surface and upper surfaces too.As per my understanding this pass box is used to aid transfer of materials from a cleaner to less cleaner or dirty zone. In this particular system it is always advised to clean with proper disinfectant, leave for 10 minits with UV light on. Then open the pass box from the cleaner side and do the air sampling and also swab sampling.
The reason is that Dirty zone always remains dirty and the impact of any microbial or fungal growth does not affect so much. But in case of a cleaner zone when you open there is every chance of transport of such unwanted viable organisms by way of sudden failures of AHU’s in you cleaner zone or by way of touching with gloves accidentally by personnel.
If you need further clarification you can post question here and I shall respod quickly.
Regards

#10

Is it required to perform UV effectiveness(log reduction with microorganism) test during Performance Qualification of Dynamic Pass Box ? only illumination test is sufficient ?