Addressing cleaning validation for new equipment with respect to existing

GOOD VALIDATION PRACTICE (cGVP) CLEANING VALIDATION
1

How we can address cleaning validation for new equipment within the existing system?

2

Hello Gajender,

1.First write a Changes in your master cleaning validation PLAN (MCVP)document and incorporate equipment in your Document.

  1. Incroporate the same equipment in your Site master file.
    3.Write a change control in MCVP & Validation masterfile.Better incorporate as Annexures.
    4.Perform a qualification programme of this new equipment.
    5.Identify the types of contaminants you encounter and identify proper cleaning agent.
    6.Size your CIP/SIP equipments for this equipment.
    7.Carry out cleaning programme .
    8.Validate its cleaning and set its limits.
    9.Properly train your staff for operation and cleaning this new equipment.
    10.Write proper SOP’s for this new ewuipment.
    11.Design a regular cleaning programme and cleaning regime.

Regards

3

Dear Mr. Gajender,

The task is not as simple as it may sound. Addition of new equipment to a manufacturing train changes the cleaning validation status of existing equipments. Let me tell you how it affects the CV of other equipments. For example: Assuming that an existing manufacturing train consisting of five equipments has a total product contact surface area = 20,000 sq. cm and the CV limit (calculated based on given surface area) = 0.5 µg/sq. cm. Now if I add any other equipment (assume having a surface area = 1000 sq. cm) to existing train, I am actually increasing the total product contact surface area (new surface area = 21,000 sq. cm) and hence, the new CV limit in that case would be < 0.5 µg/sq. cm (aprox. = 0.476 µg/sq. cm). The greater the surface area of the new equipment lesser will be the CV limit. Now the question arises as to what exactly I should do to overcome this issue. Well the answer is I have to do a proper risk/impact assessment i.e. check how the new equipment will affect your existing system and what will be the impact of the change. If the results based on earlier CV studies (for other equipments in the train) show that the amount detected in samples is lower than the new CV limit then the CV status of the equipment(s) remains valid. However, if vice versa then you have to re-validate the cleaning method(s) for existing equipment(s). This risk assessment will form the part of change control and you will need to revise your CV master plan accordingly.

Regards.

Ovais