Is it possible to operate an autoclave with DI water connection and drain in a GMP class B cleanroom ? or alternatively a 40l table-top device with 2 liter...
How can cleanroom class 9 be ensured for a production area?
How can cleanroom class 9 be ensured for a production area? With a cleanroom tailored to the process that has also been qualified in accordance with the standard.
We have a class D cleanroom and a class C clean bench in it. Our material is cleaned when it is introduced into the class D cleanroom. Does it have to be cleaned again when it is introduced / processed in the clean bench? Is there a requirement according to GMP?
We have a class D cleanroom and a class C clean bench in it. Our material is cleaned when it is brought into the class D cleanroom. Does it have to be cleaned again when...
How do you calculate the excess supply air or leakage air volume?
How do you calculate the excess supply air or leakage air volume? Many factors are required to calculate this accurately (room pressure, gap width, number, pressure in the adjacent room....). Usually, empirical values are used here.
Question 1: Is it necessary to carry out flow visualizations for sterile workbenches during periodic requalification (what interval) or is an initial flow visualization sufficient? Question 2: Is there a regulation that describes what height the front screen of the sterile workbench should be in the working position and must a new flow visualization be carried out if this position is changed?
Question 1: Is it necessary to carry out flow visualizations for sterile workbenches in the periodic requalification (which interval) or is an initial flow visualization sufficient? Question 2: Is there a regulation that describes which height...
Is it sufficient for requalifications to carry out cleanroom classifications and filter integrity (sterile operation) once a year in accordance with the current ISO 14644 or do shorter intervals (e.g. in accordance with PIC/S PI 032-2) of 6 months apply?
Is it sufficient for requalifications to carry out cleanroom classifications and filter integrity (sterile operation) once a year in accordance with the current ISO 14644 or do shorter intervals (e.g. in accordance with PIC/S PI 032-2) of 6 months apply? According to the standard...
Do you have socket cubes to hang from a cleanroom ceiling?
Do you have socket cubes for hanging from a cleanroom ceiling? No, unfortunately we do not.
Is a particle measurement of the filling alone sufficient for a qualified condition or do attached personnel and material locks also have to be measured. These differ in the pressure for filling. In other words, due to the lower pressure in the personnel airlock, particles should not actually enter the filling area. If measurements are unavoidable, they have the same measurement criteria as the filling process. And last but not least, is there an expert in AUT where you can have your SOPs assessed for correctness with regard to ISO? I look forward to your feedback.
Is a particle measurement of the filling alone sufficient for a qualified condition or do attached personnel and material locks also have to be measured. These differ in the pressure for filling. In other words, particles...
We use sedimentation plates on a daily basis, these come in a multipack of 10 plates that are shrink-wrapped several times. If 2 sedimentation plates are removed for sampling on Mondays (i.e. all outer packaging must be opened) and then plates are not needed again until Tuesdays, what is the safest way to store the unsampled plates in the opened packaging (storage in class D)? Thank you!
We use sedimentation plates on a daily basis, these come in a multipack of 10, shrink-wrapped several times. If 2 sedimentation plates are removed on Mondays for sampling (i.e. all outer packaging must be opened), and then...
Is there personal respiratory protection equipment in cleanroom class B except for work at safety workbenches?
Is there personal respiratory protection equipment in cleanroom class B other than work at safety workbenches? Surely you mean cleanroom-compatible respiratory protective equipment attached to the body. No, we are not aware of any. It would have to be checked whether they are cleanroom-compatible...
