OPERATIONAL ISSUE

 

Operational issues such as the number of products manufactured, the use of campaigns and utilization
of equipment and the complexity of the equipment impact the design of the cleaning validation
program.

In a facility the product is manufactured using different equipment such as reactor,centrifuge,agitated nutche filter, dryer etc.

For cleaning this equipment a cleanning program shall be established based for single product or multiple product

Single Product Facility - Multiple Product Facility

The circumstances surrounding a single product facility are analogous to those for dedicated
and non-dedicated equipment.

SINGLE PRODUCT

In those instances where a facility, which might be a separate
building on a large site, produces only a single product, the validation requirements are
simplified by the elimination of cross-contamination concerns.

MULTIPLE PRODUCT

Multiple product facilities (also referred to as multi-product or multi-use facilities) clearly
represent a more difficult challenge. Procedurally, steps must be taken in a multiple product
facility to ensure that cross-contamination potentials are eliminated. Change-over of
equipment from one product to another must be carefully controlled.

After cleaningvalidation is completed, monitoring programs may be warranted which ensure that all controls
are in place and that limits established during cleaning validation are maintained.