Hello all,
I’m new to this website,
I was looking for guidelines that suggest room classifications in GMP facility for columns packaging with chromatography resin.
Does anyone has a link for guidelines in this regard?
I should mention, that the column after packing will be use in D class room and I am loocking for confirmation that I do not need to use class C to the packaging process.
Thank you in advance and best regards,
Lucas.
It really depends on what your full process is - is the product terminally sterilized or sterile filtered, or is the product aseptically manufactured?
I would recommend a process flow diagram showing the steps and the level of environmental control for each step, and showing where sterile processing occurs.
But big picture…if you are using the column in a grade D later, you might be able to pack the column in a grade D as well. That is, unless you are using the column in a grade D, but in closed processing (not exposed to the environment). If you are using closed processing, you might still be cleaner than grade D.
If you have an automated and/or closed packing system you can pack in class D areas. If you have a non-automated where the packing involves physical manipulation, it needs a cleaner environment like class C areas. It should be noted that during packing one should avoid introduction of particles and/or external fibres which might cause non-uniformity of the packed bed giving rise to resolution difficulties.
Source: LinkedIn Group