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Can anyone offer information as to the 30-day expiration date rule applied to saline cubes? Does this only apply to routine patient testing? We use saline to make reagents and I need to determine how to out-date these reagents.  For example - saline expires in 30 days but is used to make PBS (we give a 6-month out-date to refrigerated PBS); which in turn is used to make enzymes (another 6-month out-date). How can I document an expiration date 1 year longer than the raw materials used to make the reagents? Any help or clarity would be most appreciated!

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I cannot say for certain if the 30 day expiration is from the manufacturer or another source. However decided that if the saline is used for dilutions of antisera or albumin we would use which ever expiration is shorter (of course ends up being the 30 days expiration for the opened saline cube). I'm sure if you validated the extension (no impact on treatments) then it shouldn't be a problem. 

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We are using Cardinal Health S/P certified Blood Bank Saline and it says right on the box that saline should be used within one month of date opened.

For solutions made from this saline, like pinktoptube, we use which ever expiration date is shorter.

 

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Thanks for the feedback! I'm working in a newer lab that is anticipating its first assessment and I want to make sure all goes as smoothly as possible.:)

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Typically expiration dates are established by the manufacturer. They perform stability testing for the duration of the assigned expiration date to support it with data. Data shows the product is capable of performing up until the claimed expiration date. It may continue to function they just do not have data to support it.

This should be done to support any "reagent" made that is not at least qualified in some way each day of use. Assigning an expiration date based upon the shortest dated component is not very good science. The different ingredients could be compatible with each other or could have a negative impact to on another. From a pure scientific and quality aspect one would prepare a reagent and place it on a stability schedule and test it periodically for performance. This data is then used to support the use. Any assessor should accept this science.

A simple analogy I like. If you made a cake today with milk that had a use by date of tomorrow does that mean the cake is not good after a day. Of course not, since it is now in a different form and could be stored in a different way. 

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Thanks JHH1999. That makes perfect sense. that explanation with a validation of the extended expiration date should be sufficient. (I hope!)

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20 minutes ago, JHH1999 said:

A simple analogy I like. If you made a cake today with milk that had a use by date of tomorrow does that mean the cake is not good after a day. Of course not, since it is now in a different form and could be stored in a different way. 

An excellent post JHH1999, however, if I made the cake today, with milk that had a use by date of tomorrow, there would be grave doubt as to whether the cake would be edible today, let alone in a few days time!!!!!!!!!!!!!

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2 hours ago, JHH1999 said:

Typically expiration dates are established by the manufacturer. They perform stability testing for the duration of the assigned expiration date to support it with data. Data shows the product is capable of performing up until the claimed expiration date. It may continue to function they just do not have data to support it.

This should be done to support any "reagent" made that is not at least qualified in some way each day of use. Assigning an expiration date based upon the shortest dated component is not very good science. The different ingredients could be compatible with each other or could have a negative impact to on another. From a pure scientific and quality aspect one would prepare a reagent and place it on a stability schedule and test it periodically for performance. This data is then used to support the use. Any assessor should accept this science.

A simple analogy I like. If you made a cake today with milk that had a use by date of tomorrow does that mean the cake is not good after a day. Of course not, since it is now in a different form and could be stored in a different way. 

Beautifully written.

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20 hours ago, Malcolm Needs said:

An excellent post JHH1999, however, if I made the cake today, with milk that had a use by date of tomorrow, there would be grave doubt as to whether the cake would be edible today, let alone in a few days time!!!!!!!!!!!!!

Malcolm - I was told (by Diana Brazier, of MRC/BGRL/BPL-D) that good serologists are often very good cooks. Are you suggesting you fall to either of the extreme sides of the Bell curve?

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21 hours ago, KLCarter said:

Thanks JHH1999. That makes perfect sense. that explanation with a validation of the extended expiration date should be sufficient. (I hope!)

Everything JHH1999 writes is sound, and perfectly laid out. I like cake, too.

I would, however, caution that one may get some regulatory push-back if one attempts to "validate" an extended expiration date on material that comes with a date assigned by the manufacturer.

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48 minutes ago, exlimey said:

Malcolm - I was told (by Diana Brazier, of MRC/BGRL/BPL-D) that good serologists are often very good cooks. Are you suggesting you fall to either of the extreme sides of the Bell curve?

No, and to be honest, and at the risk of being accused of being big-headed, I am not too bad in the kitchen.  For example, when making a lasagne, I do everything from scratch, including making my own pasta and bechamel sauce.

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On ‎2‎/‎14‎/‎2017 at 8:52 AM, Malcolm Needs said:

An excellent post JHH1999, however, if I made the cake today, with milk that had a use by date of tomorrow, there would be grave doubt as to whether the cake would be edible today, let alone in a few days time!!!!!!!!!!!!!

same here Malcolm

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On 2/14/2017 at 6:52 AM, Malcolm Needs said:

An excellent post JHH1999, however, if I made the cake today, with milk that had a use by date of tomorrow, there would be grave doubt as to whether the cake would be edible today, let alone in a few days time!!!!!!!!!!!!!

Or do you mean it wouldn't last that long due to other factors??!

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On 2/13/2017 at 1:22 PM, KLCarter said:

Can anyone offer information as to the 30-day expiration date rule applied to saline cubes? Does this only apply to routine patient testing? We use saline to make reagents and I need to determine how to out-date these reagents.  For example - saline expires in 30 days but is used to make PBS (we give a 6-month out-date to refrigerated PBS); which in turn is used to make enzymes (another 6-month out-date). How can I document an expiration date 1 year longer than the raw materials used to make the reagents? Any help or clarity would be most appreciated!

Bringing this back...

 

When a manufacturers states a product is accept for 1 month once opened. How do you calculate the expiration date? 

 - Would it always be 30 days from the day opened?

- Would you alternate between 30 and 31?

- Would you could 4 weeks?

- Do you count the date opened as day 1?

 

 

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12 hours ago, pinktoptube said:

Bringing this back...

When a manufacturers states a product is accept for 1 month once opened. How do you calculate the expiration date? 

 - Would it always be 30 days from the day opened?

- Would you alternate between 30 and 31?

- Would you could 4 weeks?

- Do you count the date opened as day 1?

 

 

My two cents: One CALENDAR month........If you open something on the 15th, it expires on the 15th of the next month, regardless of how many days are in the current month.

But...... you have to be careful to not open something on the 29th, 30th or 31st of January..., or the 31st if the next month has 30 days....:):):)

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