Setting up a new sterilization unit in a new facility

F

fenway

Hello,

Could someone guide me regarding the role of regulatory professional in helping the company set up at an entirely new sterilization facility at a new plant location? Are there any FDA guidance documents which point to the process of setting up a sterilization facility?

This is my first question in the forum, I hope someone helps me out with this!
 

Ronen E

Problem Solver
Moderator
Hello,

Could someone guide me regarding the role of regulatory professional in helping the company set up at an entirely new sterilization facility at a new plant location? Are there any FDA guidance documents which point to the process of setting up a sterilization facility?

This is my first question in the forum, I hope someone helps me out with this!

Hello and welcome to the Cove :bigwave:

What type of device(s) are we talking about? What class? What type of premarket clearance process have they gone through (510k, PMA etc.)?

I'm not aware of any FDA published guidance specific to the setup of an entirely new sterilization facility. There are, however, various regulatory requirements and associated guidance in the general context of both process control / process changes and establishment / validation of sterilization processes. The regulatory professional's role is to point them out and ensure that all applicable requirements are met. In the narrower context of part 820 (under which this thread was opened), if you look up the term "change" in part 820 you'll be able to quickly identify the relevant requirements.

HTH,
Ronen.
 
F

fenway

What is the sterilization process? You might visit the AAMI web site and check for applicable TRIs.
Hello Doug Tropf,

Thanks for pointing to AAMI website. The sterilization process we want to establish is EtO sterilization. I have tried locating the appropriate TIRs on AAMI website and found AAMI TIR28:2009/2013 for EtO sterilization. However, I couldn't go through it in detail as only a preview copy is available. I might have to request the company to purchase it. Please let me know if this approach would be correct or you have any other thoughts on this.
 
F

fenway

Hello and welcome to the Cove :bigwave:

What type of device(s) are we talking about? What class? What type of premarket clearance process have they gone through (510k, PMA etc.)?

I'm not aware of any FDA published guidance specific to the setup of an entirely new sterilization facility. There are, however, various regulatory requirements and associated guidance in the general context of both process control / process changes and establishment / validation of sterilization processes. The regulatory professional's role is to point them out and ensure that all applicable requirements are met. In the narrower context of part 820 (under which this thread was opened), if you look up the term "change" in part 820 you'll be able to quickly identify the relevant requirements.

HTH,
Ronen.
Hello Ronen E,

The sterilization unit is being set up for Class III medical devices approved via PMA pathway. The device portfolio covers different sectors like ventricular assist devices, minimally invasive surgical devices and devices for neuromodulation. I'll try understanding what different requirements are specified under "change" in 21 CFR 820.

I really appreciate the help I am getting at this community. I am a fledgling in regulatory affairs and it feels good to have kind people around. Thank you.
 

Ronen E

Problem Solver
Moderator
Hello Ronen E,

The sterilization unit is being set up for Class III medical devices approved via PMA pathway. The device portfolio covers different sectors like ventricular assist devices, minimally invasive surgical devices and devices for neuromodulation. I'll try understanding what different requirements are specified under "change" in 21 CFR 820.

I really appreciate the help I am getting at this community. I am a fledgling in regulatory affairs and it feels good to have kind people around. Thank you.

You are welcome.

You might have to submit a PMA supplement, based on 21 CFR 814.39(a):

Sec. 814.39 PMA supplements.

(a) After FDA's approval of a PMA, an applicant shall submit a PMA supplement for review and approval by FDA before making a change affecting the safety or effectiveness of the device for which the applicant has an approved PMA, unless the change is of a type for which FDA, under paragraph (e) of this section, has advised that an alternate submission is permitted or is of a type which, under section 515(d)(6)(A) of the act and paragraph (f) of this section, does not require a PMA supplement under this paragraph. While the burden for determining whether a supplement is required is primarily on the PMA holder, changes for which an applicant shall submit a PMA supplement include, but are not limited to, the following types of changes if they affect the safety or effectiveness of the device:

(1) New indications for use of the device.

(2) Labeling changes.

(3) The use of a different facility or establishment to manufacture, process, or package the device.

(4) Changes in sterilization procedures.

(5) Changes in packaging.

(6) Changes in the performance or design specifications, circuits, components, ingredients, principle of operation, or physical layout of the device.

(7) Extension of the expiration date of the device based on data obtained under a new or revised stability or sterility testing protocol that has not been approved by FDA. If the protocol has been approved, the change shall be reported to FDA under paragraph (b) of this section.

In my opinion the new sterilization facility will fall under either (3) or (4) or both; and moving to the new sterilization facility is a change that can potentially affect the safety of the device(s).

See some FDA guidance on PMA supplements here.
 
Last edited:

Doug Tropf

Quite Involved in Discussions
There are several TIRs, in addition to ISO 11135, that provide guidance on various aspects of eo sterilization. You may also have OSHA and EPA regulatory issues to comply with if you are located in the US.
 
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