Pass box qualification

Validation
1

Hi there:
Everyone know that Pass boxes are mainly used in sterile areas To avoid product 's contamination so it s mandatory To check their performance .
I request if pass boxes are placed between Two areas of the same class in purpose of transfering materials …is it crucial To qualify them?? if yes please what are the recommended tests
Looking forward for your reply.

2

Test for pass box qualifications

  1. Partical count in rest and in operation
    2.DP pressure
    3.air Flow(air visvulisation by smoke study in rest and operation)
    4.air velocity
    5.leak test by PAO
  2. Recovery test
    Make it protocol with this test as per iso14644 and PDA 13
2 Likes
3

If class are same so required static pass box with UV
check UV intensity and hour for static…
If class are different between two room then Dynamic pass box required
Check for dynamic pass box

  1. Partical count in rest and in operation
    2.DP pressure
    3.air Flow
    4.air velocity
    5.leak test by PAO
  2. Recovery test
1 Like
4

Thanks for your fast reply… would you Please share me more details about acceptance criteria of each test and their refrences ??
Kindest regards

5

Thanks for your fast reply… would you Please share me more details about acceptance criteria of each test and their refrences ??
Kindest regards …

6

Its depend on your which class to be used of room install the pass box

1 Like
7

Dear All,

  1. As per ISO 14644-3 : Recovery test is not recommended for unidirectional air flow installation, then why usually pharma companies conducting for Dynamic pass box?

  2. What should be the differential pressure for the dynamic pass box with surrounding environment and which grade to be considered with respect to?

  3. What will be the class of Dynamic pass box which will be installed between C and B area?

  4. Suppose Efficiency of pass box is conducted in static mode earlier shall it required to be conducted in dynamic condition- in actual installed area?

Thanks

1 Like