The same behavior is exhibited for the non-irradiated C1 material. The data suggested that while EVA was the primary source of the extractable acetic acid, the PE was also a meaningful source of this extractable. Merck Millipore’s lab water purification system chosen for Erasmas Medical Centre. Considering the irradiated film, the level of acetic acid in the extraction solutions are roughly constant and independent of temperature through roughly 40 days of storage, reflecting the rapid release of readily available acetic acid. Directory Resources Events Get Listed. Although other solvents were utilized, water is the most relevant for considering the migration of highly soluble low molecular weight organic acids. Secondly, there is a considerable difference in the extraction profiles at the two temperatures. Film structure affected the shape of the migration profile.
For example, it has been proposed that the films have two sources of acetic acid, the EVA layer and the PE layer. Bacterial Contamination In Clinical Analyzers. As indicated in the reference, the film for the first container type C1 was a four-layer composite consisting of ultra low-density polyethylene ULDPE as the solution contact inner layer, a polyethylene vinyl alcohol copolymer EVOH as the gas barrier layer, a polyethylene vinyl acetate EVA core layer, and an ULDPE outer skin layer. Wednesday, May 28, Addressing the irradiated film, the migration profiles have two distinct features. This is not to say that the remaining extractables are structurally similar to acetic acid; in fact, the IC analyses clearly indicate that no other low molecular weight organic acid was present in the water extracts at levels comparable to acetic acid.
Their points of comparison are Figure 3 for C1 and Figure 4 for C2. Nevertheless, mathematical models based on certain simplifying assumptions should produce calculated migration profiles that have mi,lipore same general qualitative features of the experimental migration profiles. Bringing Intelligence to Laboratory Water Purification. For example, consider the migration behavior shown by the C1 film, Figure 3.
Although acetic acid is the predominant extractable associated with both test materials, it is not the only extractable as it does not fully reconcile the TOC levels in the extracts.
PureFlex film will enable customers to have better visibility into their process container while also providing enhanced containment of their product. In addition to these obvious trends, the migration profiles contain more subtle traits that suggest certain complexities in the migration process.
Specifically, 5 liter-sized containers, both un-irradiated and after irradiation at a dose of greater than 45kGy, were filled with mL of high purity water as the extracting solvent. The clear and obvious effect of irradiation is to increase the total pool of extractable acetic acid.
Data from milkipore Although the thicknesses of the individual layers were not indicated, the total film thickness was 0. Thus data for other acids are not summarized herein. The migration profiles for the C2 material also exhibit a discontinuity but in this case the discontinuity is the inverse of that experienced by C1 and occurs at later extraction times Figure 4.
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The hypotheses related to the migration mechanism were confirmed by the use of mathematical migration modeling software. C2 was also modeled as a film that was predominately PE in terms of relative thickness of the individual layers and with an acetic acid distribution between the layers of The computer-generated migration model has the same essential properties as the experimental profile, thereby supporting the hypothesis that the acetic acid is distributed primarily between the PE and EVA layers.
Although less frequently employed in pharmaceutical applications, the fundamental scientific principles that are the foundation of the mathematical models are equally valid for both food and pharmaceutical situations. In general, the experimental and the computer-generated profiles are similar.
In general, the fill solutions were analyzed for total organic carbon TOC via appropriate instruments and methodologies. Particle size and size distribution are key factors for the manufacturing quality, as well as the efficacy and safety of medicinal nanoparticles. Published data concerning the migration of extractables from two multi-layered films PE, EVA, and EVOH layers used in bio-processing solution bags have been examined with the intent of elucidating the migration mechanism.
One anticipates that irradiation will increase the total pool of acetic acid; this effect is clearly illustrated in the increased equilibrium concentration in the migration plots of the irradiated versus the un-irradiated materials Figure 1.
PureFlex multilayer single-use process container film by Millipore.
Because the films have different layer patterns, and because the films were tested before and after irradiation, mililpore effect of film structure and irradiation on the migration of extractables, especially acetic acid, could be established. Mathematically derived migration profiles closely fit the experimental profiles, confirming that the hypotheses around the migration profiles were viable.
The TOC and acetic acid levels in the fill solutions as a function of storage time are summarized in Table 1. This profile was generated for the four layered film consistent with the conditions listed in the text. If that mechanism is valid, it should be pkreflex a the mechanism can be mathematically modeled and b the mathematical model should exhibit the same trends as were observed with the experimental data.
To this end, commercially available migration modeling software  was used to generate qualitative migration profiles for acetic acid in the irradiated films. As indicated in the reference, the film for the first container type C1 was a four-layer composite consisting of ultra low-density polyethylene ULDPE as the solution contact inner layer, a polyethylene vinyl alcohol copolymer EVOH as the gas barrier layer, a polyethylene vinyl acetate EVA core layer, and an ULDPE outer skin layer.
Multiple replicates of the irradiated bags and a single replicate of the un-irradiated bags were extracted and tested. The process, procedures, and methods used to analyze the fill solution extracts are described in reference Field Flow Fractionation Improves Characterization of Nanoformulated Medicines Product News Particle size and size distribution are key factors for the manufacturing quality, as well as the efficacy and safety of medicinal nanoparticles.
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The data considered from this study are derived from one of the three extraction sequences described in reference Ultimately, however, the models that most effectively mimicked the actual milliproe profiles were those that assigned a small portion of the acetic acid to the EVOH layer. Although the fill solutions were also tested for organic extractables by reversed phase high performance liquid chromatography RP-HPLCthese results are not relevant to the purpose of this manuscript and thus are not reported herein.
After the readily available acetic acid pool in the EVA is depleted, additionally acetic acid migrates from this second source. Common plastics used in such multilayered films include ethylene vinyl acetate EVA and polyethylene PEas they provide a relatively inert fluid contact layer and are relatively inexpensive. All contact layers are free of animal-derived components and comply with the Food and Drug Administration regulation 21 Milliipore This is consistent with reports that low molecular weight organic acids are generated from PE via irradiation for example, refs.
This profile was generated for the three layered film consistent with the conditions indicated in the text. Figures 7 and 8 are the computer-generated migration models for the irradiated C1 and C2 respectively.
Merck Millipors lab water purification system chosen for Erasmas Medical Centre. Film structure affected the shape of the migration profile.
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