T
TiSchu
Hi,
my company starts to sell sterile filler (hyaluronic acid). We act as manufacturere according to MDD but this is an OEM-product, so manufacturing is done by this OEM. This is our first sterile class III product, so we do not have much experience about that.
We do now have discussions about storage and transport of the filler.
Storage temperatur is 2-24?C so we do have a temperatur controlled storage area. This works fine.
But what about distribution. Now, in winter with temperatures below 0?C, we do have problems to protect our goods from geeting too cold. We know from our OEM-partner that temperatue below 2?C will destroy the cross-linking of the hyaluronic acid. So we deciced to the the following:
- no distribution at outside temperature below -5?C
- thermo box for distirbution
- thermo sensor indicating temperatur below 2?C in each box
Our sales departmet is very upset about the distribution stop as it seems that we are the only manufacturere of filler, that has to protect their goods from beeing damaged by cold.
They told us that all other filler manufacturer have absolutely no restrictions concerning the transport / distribution of filler.
Can someone give me a good advice how to go on with that. Is it to pedantic to stop distribution as we do it, or absolutely necessary?
By the way, our OEM-partner does not give any useful information about that. They sent us a huge batch of filler last week without having any kind of temperatur protection or control.
Many thanks for your help!!
my company starts to sell sterile filler (hyaluronic acid). We act as manufacturere according to MDD but this is an OEM-product, so manufacturing is done by this OEM. This is our first sterile class III product, so we do not have much experience about that.
We do now have discussions about storage and transport of the filler.
Storage temperatur is 2-24?C so we do have a temperatur controlled storage area. This works fine.
But what about distribution. Now, in winter with temperatures below 0?C, we do have problems to protect our goods from geeting too cold. We know from our OEM-partner that temperatue below 2?C will destroy the cross-linking of the hyaluronic acid. So we deciced to the the following:
- no distribution at outside temperature below -5?C
- thermo box for distirbution
- thermo sensor indicating temperatur below 2?C in each box
Our sales departmet is very upset about the distribution stop as it seems that we are the only manufacturere of filler, that has to protect their goods from beeing damaged by cold.
They told us that all other filler manufacturer have absolutely no restrictions concerning the transport / distribution of filler.
Can someone give me a good advice how to go on with that. Is it to pedantic to stop distribution as we do it, or absolutely necessary?
By the way, our OEM-partner does not give any useful information about that. They sent us a huge batch of filler last week without having any kind of temperatur protection or control.
Many thanks for your help!!
