vacutainer requirement in order to meet GMP compliance

My understanding is that Vacutainer is a registered trade mark of Becton Dickinson. Are you making an alternative or are you with the manufacturer?

If you are making an alternative, should you be calling it a vacutainer?

I know this is not a problem with the manufacturer

hello,actually im just study about the gmp and need sure the controlling environment for the medical product such as vacutainer,needle,etc.for my assignment i try to develop the premise that meet the gmp complice .What i know not is the level of the environment control for the pharmacutical product and medical product.Did u guys have the information.TQ

As a casual observer of this problem in the device field, may I suggest that you will not find the specification you are looking for.

Instead, you must provide a process that can confirm to regulatory bodies, that the product will meet all the biological /sterility needs for the end user.

That starts with material selection, material supplier qualification, molding processes and handling, assembly, packaging and sterilization.

In theory, you could do all this in a coal mine if you can demonstrate that you have a system that produces a sterile product. ALL THE TIME.

Overall, you will find that the cleanroom qlaification level is very basic compared to the semiconductor industry for example

ooo.tq not2smart for the response, what do you meant is the sterile product need to handle also in clean room such as the basic 1 is 10k.is it enough for sterile product?where i can refer to stick my word.

I have seen successful manufacturing in class 100,000 clean rooms and often in Class 10,000 rooms. My experience has been that our companies built and tested for class 10,000 and claimed 100,000. This provided lots of room for increased contamination as the population of the clean room grew with sales success.

Again, this may help in your planning, but it is the result as seen in the sterile product that you are after.

i see.to develop the 100k class more costy then 10 k right,so may the class 10k meet the minimum requirement for sterelise product?