Process validation of batch size range

Hi everyboby! If I have to perform a process validation of a product with a high viscosity and the batch size range is 2000 - 8000 vials, which is the worst case batch size? how many runs I have to perform for the minumum batch size and how many for the maximum one?

Hello mariannaliburdi,

As always if you have site procedures or guidelines you can refer to those. However, you can state up front what you are going to do. Firstly, you have already identified the minimum and maximum batch size. If there is no change in the composition of the product i.e active etc, then your worse case can be 2000 and 8000 vials.
You can take a matrixing/bracketing approach. You can perform three runs with two at maximum batch and one at minimum batch. But the rationale needs to be upfront. Problem with this approach is that if one batch fails (min -max ) then the entire exercise is a failure.
However, the other approach is to do three runs of the min and three of the max which may not be feasible, especially if the product is only made and filled once every year.

Dear mariannaliburd,
As per ISO 13408

  1. Production batch size of 3000 units and greater
    minimum 3 media-fill for total 9000 units
  2. It may be necessary to fill more than 3000 units per media-fill run in order to accommodate process variables and intervention routinely encountered during production
    3.Media fill studies should be representative of actual product/ container configuration to be filled.
  3. Actual product/container configuration that is representative of other products on the filling line.
  4. Two products which brackets all others w.r.t. size, fill, container opening, line speed, manipulation.
  5. Product which have been deemed to be worst with respect to the opportunity for contamination e.g. container which has largest opening and is conveyed at the slowest speed.
    7.Media fills shall be conducted on separate days, at different times during the normal working period.
  6. A list of permitted and proscribed intervention events that could occur during the aseptic processing shall be available.
  7. Media fill shall be conducted under conditions including “worst-case” like permitted interventions, replacement or repair of filling needles, no. of personnel involved.
  8. Media-fill run shall be of sufficient durations to cover most manipulations and operations that normally occurs during process
    There are many further details which you can see in ISO 13408 guidelines
    Dr, Pradeep Nagalkar