Dear All,
As the cycle for garments and acessories are same (HVHP). Whether we can use same cycle with garments + accessories. or is there any regulatory issue.
Regards
I see two issues in this:
- How well the garment + accessories load is validated for the cycle completion? This relates to penetration study during validation of load–Did you perform similar study during validation cycle?
2.Garments and Accessories are different materials with different steam penetration abilities. They are different materials that should be handled differently. How the sterile garments are handled during the removal once the cycle is completed? How can you be doubley sure that they remain intact during handling with other materials? The whole concern in point 2 is pnetration of steam and Training of staff.
Regards
My heat penetration studies resulted in garment cycles that required twice as many pre-vacuum phases and twice the exposure time of accessories to achieve similar results.
If the loading pattern of garments bins and other accessories is properly designed I don’t think there is any regulatory issue in this. The loading should be such that there should be adequate steam penetration in all parts of load.
Hi,
Yes, I do agree. Load pattern to be defined by the organization based on their set up a avalable facilities. Agencies are looking for requiremnet part i.e sterilization.
If a existing load is validated & you have to add something else in that load…(assuming the process of sterilization is same) based on assessment one should go for validation & can incorporate the additional items.
While doing changes in any existing system you should be ready to answer the questions, as already suggested by Mr. durga i.e. Training & Sterilization study validation. In addition to this you should work with justification part as well.
Happy Reading !