Pre Filled Syringes (PFS) - Effect of Containers on the Contents

Ajit Basrur

Staff member
Admin
#1
Hi all,

I am looking for good articles / presentation on the Pre filled Syringes (PFS) with reference to the effects that the containers have on these syrines.

:thanx:
 
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Jim Wynne

Staff member
Admin
#2
Hi all,

I am looking for good articles / presentation on the Pre filled Syringes (PFS) with reference to the effects that the containers have on these syrines.

:thanx:
There's a fairly comprehensive article on the subject of pre-filled syringes here and you might find additional useful resources in the references at the end of the article.
 
A

Alexisss

#3
Hi all,

I am looking for good articles / presentation on the Pre filled Syringes (PFS) with reference to the effects that the containers have on these syrines.

:thanx:
I would advise you to check the ISO 7886 series of standards for syringes. These are for the syringes as medical devices, and for insulin syringes.

In ISO 7886-1, there is a test for "absorbance" (informative - not compulsory). This test compares the absorbance (spectrophotometry) of four extracts of the (internal part of the) syringes at 25oC for 1hr, 37oC for 1hr, 25oC for a day, and 37oC for a day. The meaning that the absorbance difference shall be up to 1 OD unit (optical density unit) is that there are no substances leaching from the internal parts of the syringe no matter for how long the liquid was kept in the syringe. Therefore, you have a "constant" quality of product. However, this standard does not judge whether the quality is good or not (whether the substances that do leach affect the body negatively or not). It just assures that you have a constant quality, but does not tell you if this quality is good or not.

The fact that you have a constant quality of product allows you to move to the next assessment, the Biological Evaluation of the syringes, with standards in the ISO 10993 series, that gives you information on whether the things that leach in your liquid cause you a problem or not.

ISO 7886 also has a test for heavy metals, therefore you also check that there are no heavy metals leaching, or that their level is low/acceptable.

So, by having performed a biological evaluation you know that the syringe will PROBABLY not harm your product.

Keep in mind that the Pharmacopoeia test for absorbance is different, requiring the absorbance to not be higher than a specific figure.

Therefore, the difference in the 2 evaluations (one with ISO 7886 and the one of the Pharmacopoeia) is that "ISO allows you to have some kind of substances leaching in your liquid, but their amount must remain constant" where as "Pharmacopoeia requires minimal amount of substances leaching".

You may choose a good quality syringe that does not have chemicals leaching, that will make your life easier during your biological and your clinical evaluation.

I am sorry I do not have further info on specific chemicals that may be leaching and their reactions with pharmaceutical substances.
 
A

Alexisss

#5
my pleasure!

if u give me further info on your device/application i may try to assist you further
 
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