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Unvalidated Equipment

We are manufacturing aseptically filled and thermally sterilsed products.
Can you have an unvalidated piece of equipment in a cleanroom ( Grade C or D)? (The equipment is only used for drying) All we need to do is ensure glassware is dry.

Thank You

If you think that the process is not so critical then you might not validate it. But I feel that in your case atleast to have few checks (Verification) of your equipment and then use it for drying.:slight_smile:

[quote=Austin]We are manufacturing aseptically filled and thermally sterilsed products.
Can you have an unvalidated piece of equipment in a cleanroom ( Grade C or D)? (The equipment is only used for drying) All we need to do is ensure glassware is dry.

Thank You[/quote]

Dear Austin,
you set the specifications yourself. If you need the glassware to be dry for a reason probably to comply to cGMP then you HAVE TO VALIDATE. Especially since you are referring to a Grade C area.

I think this would be the concept of an auditor conducting a visit to your premises.

Best regards,

Dear Austin,
Hi, This is Jasbindersingh from Kamal Counsultants.
I understand that you are using an equipment / tool to dry glassware in sterile area. Please remember that anything introduced in sterile area, is prone to contaminate the area / product and so on. So, inspite of non-critical with respect to the process, it is necessary to establish that this piece of equipment is not adding contamination. This can be established through proper validation.
You can cover this in your validation programme and also can be part of mediafill activity. More details are required to know how to proceed on this aspect.

Regards,

Jasbindersingh
(kamal.consultants@hotmail.com)

On a regulatory side, yes, we would want the equipment to be validated.

In general, if it is in a classified area, it should be validated, regardless of critical vs non critical status. What may change is the level of validation.

Maybe an IQ/OQ would be sufficient for non critical, for more critical, a PQ + Cleaning Validation would be warranted.

I think the equipment should be risk assessed. If it is not directly contact with the product or no impact on the product, the validation is not necessarily required, but control measures should be considered, and evaluation should be made to see if the control measures is effect. otherwise, if it directly contacts or has direct impact on produdct quality, it must be validated, although 1 or 2 pages are needed.