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Single use non-sterile syringe used in the oral cavity - Laboratory test advice

#1
We have a single use non-sterile syringe used in the oral cavity which we would like to place on the US and European market. The syringe is made of polypropylene (same material as regular syringes)

We are being advised by the lab that we should conduct the below tests to validate packaging:

AGING TEST
ASTM F1980


PACKAGING VALIDATION TEST
ASTM F1140 BURST AND CREEP TEST
ASTM F1929 DYE PENETRATION
ASTM F88 SEAL STRENGTH TEST
ASTM F1866 VISUAL INSPECTION (at 0-YEAR/3-YEAR ACCELERATED AGING)

The quote they have provided is, in my opinion, not cheap. I would like advice as to whether we need to have all these tests done given the product in non-sterile (in particular ASTM F1980 for 510(k) exempt and also CE class 1(non-sterile and non measuring) under the new MDR requirements.

Having looked at the ASTM F1980, I do not think it applies to our product as it is not sterile. However, the lab argue that it needs to be done to claim shelf life. They also claim that the tests need to be done to meet the below MDR requirements

Clause 7
Devices shall be designed, manufactured and packaged in such a way that their characteristics and performance during their intended use are not adversely affected during transport and storage, for example, through fluctuations of temperature and humidity, taking account of the instructions and information provided by the manufacturer.

Clause 10.2
Devices shall be designed, manufactured and packaged in such a way as to minimise the risk posed by contaminants and residues to patients, taking account of the intended purpose of the device, and to the persons involved in the transport, storage and use of the devices. Particular attention shall be paid to tissues exposed to those contaminants and residues and to the duration and frequency of exposure.

I would appreciate it if you could advice me as I am unclear of the requirements and feel the lab is pushing to get business rather meet the necessary regulatory requirements.

Do I really need the above listed tests for our product for FDA and CE?
 
#2
Ahmed,

the listed ASTM standards are typically used to demonstrate packaging integrity of _sterile_ barrier systems according to ISO 11607-1. You can use these tests to not only demonstrate that your packaging is capable of maintaining sterility of your packaged device over the labelled shelf life and during distribution, but more generally any defined microbial state that you have specified.

I assume that you have actually defined a microbial state of your device? If yes, this explains why your lab is thinking for tests into the direction of sterile barrier systems. The proposed tests aim at the following: demonstrating both seal integrity and whole-package integrity, the two aspects you typically address during your package stability & performance validation.

Bottom line: if you have a defined microbial state then the proposed tests may be reasonable. If you do not have to maintain a defined microbial state then these tests are beyond scope.

HTH,

Gerhard
 

Ronen E

Problem Solver
Staff member
Super Moderator
#3
We have a single use non-sterile syringe used in the oral cavity which we would like to place on the US and European market. The syringe is made of polypropylene (same material as regular syringes)

We are being advised by the lab that we should conduct the below tests to validate packaging:

AGING TEST
ASTM F1980


PACKAGING VALIDATION TEST
ASTM F1140 BURST AND CREEP TEST
ASTM F1929 DYE PENETRATION
ASTM F88 SEAL STRENGTH TEST
ASTM F1866 VISUAL INSPECTION (at 0-YEAR/3-YEAR ACCELERATED AGING)

The quote they have provided is, in my opinion, not cheap. I would like advice as to whether we need to have all these tests done given the product in non-sterile (in particular ASTM F1980 for 510(k) exempt and also CE class 1(non-sterile and non measuring) under the new MDR requirements.

Having looked at the ASTM F1980, I do not think it applies to our product as it is not sterile. However, the lab argue that it needs to be done to claim shelf life. They also claim that the tests need to be done to meet the below MDR requirements

Clause 7
Devices shall be designed, manufactured and packaged in such a way that their characteristics and performance during their intended use are not adversely affected during transport and storage, for example, through fluctuations of temperature and humidity, taking account of the instructions and information provided by the manufacturer.

Clause 10.2
Devices shall be designed, manufactured and packaged in such a way as to minimise the risk posed by contaminants and residues to patients, taking account of the intended purpose of the device, and to the persons involved in the transport, storage and use of the devices. Particular attention shall be paid to tissues exposed to those contaminants and residues and to the duration and frequency of exposure.

I would appreciate it if you could advice me as I am unclear of the requirements and feel the lab is pushing to get business rather meet the necessary regulatory requirements.

Do I really need the above listed tests for our product for FDA and CE?
It seems that the lab is either trying to get business or just running auto-pilot (being lazy?). Some of the tests *might* be relevant but it's not obvious and it'd be their onus to explain why (if they care enough about your business).

You do need to address both shelf life and packaging suitability/integrity, but in a more general way and with a little more analysis as to what is actually required.

For general packaging validation and testing maybe have a look here.
 
#4
Ahmed,

the listed ASTM standards are typically used to demonstrate packaging integrity of _sterile_ barrier systems according to ISO 11607-1. You can use these tests to not only demonstrate that your packaging is capable of maintaining sterility of your packaged device over the labelled shelf life and during distribution, but more generally any defined microbial state that you have specified.

I assume that you have actually defined a microbial state of your device? If yes, this explains why your lab is thinking for tests into the direction of sterile barrier systems. The proposed tests aim at the following: demonstrating both seal integrity and whole-package integrity, the two aspects you typically address during your package stability & performance validation.

Bottom line: if you have a defined microbial state then the proposed tests may be reasonable. If you do not have to maintain a defined microbial state then these tests are beyond scope.

HTH,

Gerhard
Thank you Gerhard and Ronen.

We have not defined any microbial state. The lab insists that we need to do these tests to meet the new MDR. I would have said fine if the costs were not as extortionate.

Do we need to specify a shelf life for a medical device under MDR and also are there any general standards that we can use to demonstrate we meet the packing validation?
 
#5
Ahmed,

if you do not have a defined microbial state then you would only need packaging that protects your device from excessive soiling during distribution. A transport simulation of your device in its distribution packaging configuration, e.g. according to ISTA 2A (follow Ronen's link), could be sufficient.

You only need to specify a shelf life if your device (including its barrier system) is prone to aging - if not, nothing to validate here.

You mentioned that your device is used in the oral cavity: does your device require disinfection prior to use?

HTH,
 
#6
Thanks for your further advice Gerhard.

We do not reccomend disinfection as we manufacture and package the syringes in cleanrooms. We were thinking of introducing a process to randomly select samples for bioburden testing to ensure the packed product meets a certain standards. Not sure if we need this so not implemented.

Do you think syringes made of polypropylene require an aging test?
 
#7
Ahmed,

I presume you manufacture in a clean-room, because your device does indeed have cleanliness requirements regarding viable and non-viable contamination, right? And you want to maintain this state until the point of use? If yes to both questions, then your lab's proposal does not appear that far-fetched anymore.

If your packaging has to maintain this state, then your packaging is the driver for performing aging studies, typically not your device: (Pure) Polypropylene is typically stable when not exposed to environmental stress, such as (UV) radiation and extreme temperatures and humidity over extended periods of time.

HTH,
 

Ronen E

Problem Solver
Staff member
Super Moderator
#8
Ahmed,

I presume you manufacture in a clean-room, because your device does indeed have cleanliness requirements regarding viable and non-viable contamination, right? And you want to maintain this state until the point of use? If yes to both questions, then your lab's proposal does not appear that far-fetched anymore.

If your packaging has to maintain this state, then your packaging is the driver for performing aging studies, typically not your device: (Pure) Polypropylene is typically stable when not exposed to environmental stress, such as (UV) radiation and extreme temperatures and humidity over extended periods of time.

HTH,
1. As much as I currently understand the application and the design, it's a syringe loaded with a prefilled cartridge, so the syringe itself might not have high cleanliness requirements. I don't think any of us here can give responsible, specific advice (yet), because we currently know very little about the device.

2. Where several components are assembled together, substantiating a shelf life is likely to involve more than individual materials stability under a given set of environmental conditions. Factors like creep, stress cracking, compression set etc. may become relevant, depending on the various materials used and the geometrical design. Phenomena like spontaneous (unintended) adhesion, difusion, leaching, absorption, modification of boundary layers etc. should also be considered when components are in close contact or pressed together for prolonged periods. So again, I wouldn't say anything too definite without getting to know the design really well first.
 
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