Dear Friends,

Our company is going to install an isolator for manufacturing the high potency products.

I am new to this isolator and I am interested to know about the following:

a. Qualification or validation strategy for isolator.
b. Any special requirements if any.

Regards / Raghu

I'm curious, and probably others here who might actually be able to help will need to be certain of your meaning as well...what's a "high potency product"? Are we talking pharmaceuticals?

Yes it is related to Pharmaceutical manufacturing.

Many processes require containment to ensure that people and the environment are protected from exposure to the chemicals involved.

It could be the product itself or any of the raw materials or intermediates being handled that exhibits toxic or highly potent properties.

Many oncology products are highly potent and fall into this category.

Raghu,

Most isolator suppliers give very comprehensive validation package - did you contact them ?

We are in the very initial stage and we are in contact with suppliers.

I don't want to miss any thing from the vendor and that is the reason i posted the query.

If there is any specific requirement kindly let me know.

Regards / Raghu

We are in the very initial stage and we are in contact with suppliers.

I don't want to miss any thing from the vendor and that is the reason i posted the query.

If there is any specific requirement kindly let me know.

Regards / Raghu
Hi Raghu,

I am very late in responding, but I have one piece of advice that you may find useful. Isolators can be an ergonomic nightmare, as operators are all different shapes and sizes and what works for one won't necessarily work for another. What I always do when specifying isolator technology (I have specified and sourced more than twenty now) is have a full size model made from wood and cardboard and then let my operators have a play with it, with the manufacturer present. That way they can comment on sight lines, how far they can reach, stance, comfort, seating, size and location of glove ports/half-suits etc.. The design can be tweaked there and then using a pair of scissors; the operators feel involved in the selection process and the manufacturer knows precisely what you want.

Although this usually costs a couple of hundred dollars extra it can save a huge amount of hassle further down the line. The final model can even be photographed and referenced in the Design Qualification.

Jimmy

Dear Jimmy,

Thanks and we will follow as per your instuctions.

I am specifically interested on PQ part.

Whether we need to monitor the Isolator routinely for its compliance to the defined class and also for microbiological parameters?

If that is the case means is it possible to sample?

We are in the very conceptual stage.

Regards / Raghu