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Re: Crow3 post# 41478

Wednesday, 10/09/2013 3:46:11 PM

Wednesday, October 09, 2013 3:46:11 PM

Post# of 45771
Wrong. Sorry Crow3, but shelf-life of parenteral drugs has been an issue of concern for a long time, and because CDEX's ValiMed G4 can perform analysis with the drug in-the-container and sterility is not compromised, and because the VG4 can analyze vials, syringes, and bags, your assumption that it is only a "loaded drip bag" as you call it is an incorrect assumption.

Your words and beliefs tell you've never worked in a hospital pharmacy.

Because the ValiMed G4 system identifies both the drug and the concentration, in vials, bottles, etc, shelf life studies makes perfect sense.

2012
Requirements of product purity, activity and shelf life order high standards for parenteral drug packaging. As said, parenteral drug packaging is among the toughest jobs that packaging service providers will have to do

The pharma industry is known to deal with most sensitive products that directly decide life and death of the consumer. Therefore there is zero tolerance for any changes in the appearance or characteristics for a pharma product.

The parenteral drugs category is perhaps the most sensitive product category in the pharma industry

http://pharma.financialexpress.com/specials/packaging-special/1221-effective-packaging-solutions-for-parenteral-drugs

Parenteral Drug Association
Stability of Parenteral Drug Products

http://www.pda.org/Chapters/North-America-cont/New-England/Presentations/Stability-of-Parenteral-Drug-Products.aspx

National Institutes of Health PubMed
Parenteral methotrexate: effective shelf-life following initial puncture of preservative-protected vial.

http://www.ncbi.nlm.nih.gov/pubmed/7718017

What about future potential?? When CDEX reaches the point where hospitals and pharmacy professionals begin testing the VG4 with TPNs, shelf life issues remain in the picture.

It is obvious that not all the potentially possible TPN mixtures can be tested in the laboratory for compatibility and shelf life. On the other hand there is no theoretical way to predict the compatibility and shelf life of such mixtures. As a consequence over the years there has been a trend towards the use of standardised TPN regimens of known compatibility and shelf life.

http://www.iv-partner.com/index85ac.html?58D7F237CD0E463AA80465F4B81001BB

For drugs with suitable stability in intravenous solutions, premixes provide an alternative to the extemporaneous compounding of admixtures. These products are ready to administer, reduce the chance for a medication error, reduce the potential for infection, and decrease the chance for needlestick injuries. In addition, there is an advantage in using these products with respect to the shelf-life of the product.
Lecture series (Ukraine)
Technology of parenteral preparations

...internal/pharma_3/lectures_stud/Industrial%20drugs%20technology/4-course/English/Technology%20of%20parenteral%20preparations..htm

= = = = = = =

The CDEX ValiMed G4 is described as having unique and novel aspects, with the capability of providing the identification of drugs (and not just parenterals!~), and near real time analysis of the concentration. Shelf life studies, of pharmaceuticals in a bottle, vial, syringe, or any FDA approved IV bag makes perfect sense. Your beliefs are, again, unfounded.

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