ISO stipulates validation of packaging processes to ensure that the packaging process used for health care facilities and industries where medical facilities are used are properly packaged and are sterile before they are used on a patient. Validation ensures that packages such as pouches and reels remain sterile until the open them
As a prerequisite, the materials used for packaging must be suitable for the medical device and need to be for the intended packaging and sterilization process. Listed below are the guidelines for validation of packaging processes. The guidelines main objective is to ensure uniformity, to avoid confusion and ensure that medical devices achieve the highest quality of packaging before they are used on a patient
Guideline for validation of packaging processes
The validation process involves
- Drafting of the validation plan- The first processes is to come up with a draft detailing what the validation process should contain and how the entire process ought to be carried out. The validation plan should at least contain responsibilities, description of the sealing procedures, description of materials used in the packaging process, description of the sterilization process and steps of qualifications.
- Implementation of Validation – The implementation consists
- Installation qualification (IQ)- This is the process of acquiring and document evidence that the medical equipment has been supplied and documented according to specifications.
- Operational Qualification(OQ)- The OQ ensures that the installed equipment operates within the set limits when used according to procedures
- Performance qualification(PQ)- As the name suggests the PQ gathers evidence whether the equipment will perform as stipulated
- Compiling of the Validation report- The validation report and findings must be complied in a report consisting of the validation plan, evidence of the validation plan, results evaluation, approval of validation, etc
- Formal approval of the validation- The compiled and evaluated validation report need to be approved by the operator responsible.
- Process control and monitoring- After validation, standard operational procedures need to be defined. Routine tests need to be defined and any changes made in the sealing procedure made known in good time.
- Process changes and revalidation- Process changes need revalidation to show and document all the processes occurring during the sterilization process. Revalidation is meant to show evidence that the packaging procedure is done within the limits defined at the initial validation stage. All changes need to be documents in the revalidation report to help in tracking all changes made during the validation and revalidation stages.