PQ of new bioburden testing method - where to begin?

GOOD DOCUMENTATION PRACTICE (GDocP) PQ (PERFORMANCE QUALIFICATION)
1

I want to switch our bioburden test method from the Milipore Milliflex Pump system to a 3-port aluminum vacuum manifold (simpler and much more cost-effective), and am having a hard time designing a good PQ. I’m the sole microbiologist at my job, and don’t have much experience outlining a process validation from scratch. The system will be used to test PW, as well as pharmaceutical samples. Can I just validate by spiking with a known number (<100 CFU) of organisms and showing that this would be reflected in the bioburden results? This seems too simple. Any help/advice would be greatly appreciated!

2

I think that the approach you suggest is sensible and it is the approach I would take. As they always say … keep it simple! Complex validation procedures build in LOTS of oportunities for things to go wrong - problems in executing the protocol and duff results resulting in lots of lovely deviations.

The selection of “spiking” organisms is important.

I would suggest that you use the pharmacopoeal organisms - e.g. E coli, Salmonella, Ps. aurginosa. For water tests I would also recommend using Burkholderia cepacia (or what ever Ps. cepacia is called nowadays!) AND examples of typical or regularly isolated water organisms from YOUR system (I assume that you get the occasional water borne other Psedomonads and similar G-ve rods.) Similar for your pharma samples - the pharmacopoeal organisms and typical isolates from routine bioburden testing.

What might be difficult is making the spiked test samples with low numbers of bugs as it could be difficult to get a homogenous suspension with so few organisms - for establishing the spiking levels.

I hope that this is of some help.

3

[FONT=inherit]I would repeat the same PQ performed for the Millipore system (if it was done), The test method (filtration) is not changed.[/font]

4

Thanks so much, David - I appreciate the response!

5

Hi Graham-
The Milliflex pump system that we’re currently using dates back to the late 1980s, and if a PQ was performed (which I doubt), it is unfortunately long gone. I do appreciate the response!