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
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.
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
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.
Stability of a pharmaceutical product is defined by USP-NF as the “extent to which a product retains, within specified limits and throughout its period of storage and its use (i.e., its shelf life),
Determination of beyond-use dating for compounded preparations can be challenging and is based on stability studies when such data are available
Concerns regarding stability had led the pharmacy staff to prepare three syringes each of succinylcholine (10 mL of 20 mg/mL) and ePHEDrine (10 mL of 5 mg/mL) every other day to stock in the labor and delivery anesthesia cart. The succinylcholine was drawn into a 10 mL syringe directly from the 10 mL vial. For ePHEDrine, normal saline was used to first dilute the 50 mg/mL, 1 mL ampul to a final concentration of 5 mg/mL. However, each 10 mL dose was prepared in a 20 mL syringe to help differentiate the two drugs.
regulatory requirement for distinct specifications for release and for shelf-life where different. ...... c) Sterility: All parenteral products should have a test procedure and acceptance criterion .... (Example: Compound A has as its lowest solubility at. .................. Stability and degradation kinetics of etoposide-loaded parenteral lipid emulsion. ... The shelf life (T(90%)) of etoposide in lipid emulsion was estimated to be 47 days ... ...................... ... be large enough to maintain the product pH for a reasonably long shelf-life. ... On the other hand, the buffer capacity of ophthalmic and parenteral products ... ........................
CDEX Ships ValiMed G4 Medication Validation System
Prominent Global Medical Technology Company to Use for Research and Development
the first ValiMed™ G4 drug validation system to a prominent US based global medical technology company. The company intends using the ValiMed G4 as a lab instrument for a research and development project to determine the shelf life of parenteral admixtures with regards to potency over time.
The ValiMed G4 allows them to retain product sterility by performing analysis through the container.
The ValiMed G4 uses Raman Spectroscopy data, plus Fluorescence Spectroscopy data, plus Reflective data in a simultaneous and unique manner to obtain an optical signature, and uses those same processes to capture the optical signature of a target of interest (say, a parenteral admixture, a drug in a vial, an irrigation solution in a bottle or FDA approved bag, etc etc, and provides the user with drug ID as well as concentration.
The global medical technology company that got the first ValiMed G4 was apparently happy with the drug signatures available and are using it to do just what has been published...determine the shelf life of parenteral admixtures with regards to potency over time.
To see what the ValiMed G4 system is designed to do, check the patent app
United States Patent Application 20130120741 Kind Code A1 POTEET; Wade M. ; et al. May 16, 2013
-------------------------------------------------------------------------------- CHEMICAL AND MOLECULAR IDENTIFICATION AND QUANTIFICATION SYSTEM UTILIZING ENHANCED PHOTOEMISSION SPECTROSCOPY
Abstract
An enhanced photoemission spectroscopy (EPS) system uses at least three photoelectric detection processes to identify a substance or substances in a target. The target can be in a container, and the EPS system accounts for this in the identification process. The photoelectric detection processes include Raman scattering, fluorescence and spectral reflection. The EPS system uses all three processes to generate spectral data that is then combined to derive a target signature. The target signature is then compared to stored signature data to determine the substance or substances in the target.
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