Cleaning instructions for our non sterile, single use products

A

Annro

#1
Hi :bigwave:
I have recently been asked for cleaning instructions for our non sterile,single use products.My first thought was are they reusing them, which they don`t. Could anybody tell me if you have to provide these instructions for non sterile single use products, if so a little bit of advice on how i go about it would help.

Thanks:thanx:
 
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somashekar

Staff member
Super Moderator
#2
Re: 13.6 ESSENTIAL REQUIREMENTS

Hi Annro.
Welcome to the COVE.
What device is your's ?
Who asked you .... The customer ? of the NB auditor ?
How does it go about getting handled during the production, and finally before your packaging, do you have a stage to clean it ?
When you agree that the device you make has to be both effective and safe, are you doing anything about possible / probable contamination of your device before it gets packed ?
Depending upon what type of device it is, you may have to consider this final cleaning stage that will disinfect and clean the device.
Clinically clean is a catchy word that is often used in your situation. Is your device clinically clean ?
As an example, we have a cable accessory that we make. It passes through various hands of various operators. Though we have established a clean and hygienic environment and workforce. we do have a final clean and inspection stage just before the pouch packing. This in our case is as simple as giving a good wipe with a soft tissue dabbed in IPA.
 

Ronen E

Problem Solver
Staff member
Moderator
#3
Re: 13.6 ESSENTIAL REQUIREMENTS

I agree, it really depends on the intended use. You are required to provide the user with all information that is required for safe use.
 
A

Annro

#4
Re: 13.6 ESSENTIAL REQUIREMENTS

Hi Somashkar

The Device is silicone nasal splint and the customer has asked for this. Their process when having purchased non sterile products is to put them through a washer disinfector before sterilization ,they want verification that they can do this with our product. We provide sterilization instructions with the product but have not been asked before for the washer disinfector.
The product is done in a class 8 clean room, washed and dryed before packaging.

Thankyou for your reply Somashekar
 

Ronen E

Problem Solver
Staff member
Moderator
#5
Re: 13.6 ESSENTIAL REQUIREMENTS

Hi,

So I gather that you (the manufacturer) do not deem such additional pre-sterilization cleaning & disinfection necessary, and by face value it seems reasonable to me. Hence, it comes down to your customer's C&D process not harming the splint. My natural instinct would be that this should have been part of their selection and qualification process, before qualifying your product. However, the commercial situation could be such that you'd want to volunteer performing such a verification / validation for them and providing a final report.

I wouldn't go as far as a mini-research to develop the most appropriate C&D method (which you deem unnecessary anyway), but it's really a mater of commercial relationship rather than a technical / regulatory issue, IMO.

Cheers,
Ronen.
 
Last edited:

somashekar

Staff member
Super Moderator
#6
Re: 13.6 ESSENTIAL REQUIREMENTS

Hi Somashkar

The Device is silicone nasal splint and the customer has asked for this. Their process when having purchased non sterile products is to put them through a washer disinfector before sterilization ,they want verification that they can do this with our product. We provide sterilization instructions with the product but have not been asked before for the washer disinfector.
The product is done in a class 8 clean room, washed and dryed before packaging.

Thankyou for your reply Somashekar
A very important product related information in medical devices is the information about terminal sterilization process and the method used. This is a very important piece of information for the pre-sterilized device manufacturer to select the material, method and the final cleaning process as well as the work environment. All these will keep in check the challenge to the sterilization process. Please can you begin to look on these lines now. Better late then never.
 

Ronen E

Problem Solver
Staff member
Moderator
#7
Re: 13.6 ESSENTIAL REQUIREMENTS

A very important product related information in medical devices is the information about terminal sterilization process and the method used. This is a very important piece of information for the pre-sterilized device manufacturer to select the material, method and the final cleaning process as well as the work environment.
But the OP has clearly stated:

We provide sterilization instructions with the product...
The product is done in a class 8 clean room, washed and dryed before packaging.
So as far as the unsterilized product manufacturer is concerned, the methods to ensure proper pre-sterilization cleanliness are already implemented in-house, and the instructions for matching sterilization are provided to the downstream buyer. The fact that a customer insists on adding an extra process (that may be redundant) has nothing to do with the manufacturer fulfilling their responsibilities.
 
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