MILLIPORE PUREFLEX FILM
Ideally suited for bioprocessing applications such as media, buffer preparation, process intermediates, bulk storage and transportation of biopharmaceutical fluids in sterile conditions, the new PureFlex film is a high purity, multilayer medical-grade film that offers exceptional clarity and gas barrier performance. The levels of organic acids in the retrieved fill solutions were measured using ion chromatography IC , performed using conventional columns, mobile phase gradients, and detection techniques. Vishal Barge is a Research Scientist at Baxter, serving as a subject matter expert SME on topics related to analytical chemistry and extraxctables and leachables assessment. 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. Although other solvents were utilized, water is the most relevant for considering the migration of highly soluble low molecular weight organic acids. The clear and obvious effect of irradiation is to increase the total pool of extractable acetic acid. For example, consider the migration behavior shown by the C1 film, Figure 3.
Get Merck news direct to your inbox. After 20 days, the levels of acetic acid increase, roughly in nillipore to the contact temperature. It is intuitive to suspect that there will be major differences in the migration profiles as a function of material irradiation and the structure of the two container films.
In general, the fill solutions were analyzed for total organic carbon TOC via pureflx instruments and methodologies. Examination of the structures of C1 and C2 reveal that PE is the layer that meets these two criteria and it is concluded that the PE is the source of the secondary acetic acid.
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.
Specifically, C1 was 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 approximately 1: Although other solvents were utilized, water is the most relevant for considering the migration of highly soluble low molecular weight organic acids.
The migration of acetic acid was affected by both irradiation and film structure. In the previous discussion of the migration profiles, we proposed essentially a compartmental mechanism for mjllipore acid migration, based on an empirical analysis of the available data. 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.
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 upreflex extracting solvent. For example, consider the migration behavior shown by the C1 film, Figure 3.
Film structure affected the shape of the migration profile. The total thickness of this film was 0.
The clear and obvious effect of irradiation is to increase the total pool of extractable acetic acid. The upper migration profile is for the irradiated material and the profile at the bottom is for the un-irradiated material. While the acetic acid levels in the C2 film almost immediately reach their equilibrium value because their migration pathway is smallthere millipoore a considerable lag in the migration profile of the C2 film as the acetic acid must migrate through both EVOH and ULDPE layers before it is released to the fill solution.
Merck Millipore aims to make lab work easier and more efficient with the launch of its Milli-Q IQ 7…. Nevertheless, the migration profiles for total organic extractables, as reflected in TOC, mirrored the migration profi les of acetic acid.
Although the extractables profile of the films included compounds other than mmillipore acid, these compounds were not quantified so nillipore to produce individual migration profiles. Both polyethylene layers will be designated as PE in the remainder of the text.
PureFlex multilayer single-use process container film by Millipore.
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. 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 purefleex. After the readily available acetic acid pool in the EVA is depleted, additionally acetic acid migrates from this second source.
PureFlex film enhances ease of use and containment
While the levels of acetic acid and TOC in Table fim appear to be comparable, this is misleading as the carbon fraction of acetic acid is 0. Vishal Barge is a Research Scientist at Baxter, serving as a subject matter expert SME on topics related to analytical chemistry and extraxctables and leachables assessment. Data from reference Millipore announces a new multilayer single-use process container film with exceptional clarity and robustness.
The newest addition to the Mobius line of flexible bioprocessing pueeflex, PureFlex single-use process container film has been introduced at the ‘disposables for biopharmaceutical production’ track during IBC’s Biopharmaceutical Manufacturing and Development Summit, December in Orlando, FL.
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. For example, it has been proposed that the films have two sources of acetic acid, the EVA layer and the PE layer.
This profile was generated for the three layered film consistent with the conditions indicated in the text. Considering C2, both the computer-generated profiles effectively mimic the phreflex data.
In the current manuscript, these migration data are considered in the context of those milllipore which effect the migration of these types of extractables and in terms of the ability of milliplre mathematical migration pureflwx to mimic the observed migration profiles. Don’t have an account? Although the thicknesses of the individual layers were not indicated, the total film thickness was 0.
While the IC analysis considered analytes other than acetic acid, acetic acid is the predominant extracted organic acid and thus was specifically examined in this study. Because the films have different layer patterns, and because the films were tested before and after irradiation, the effect of film structure and irradiation on the migration of extractables, especially acetic acid, could be established.
In general, the experimental and the computer-generated profiles are similar. Business continuity plans have been established to ensure uninterrupted global supply of these films and products. The nature of the test articles and the conditions under which the study was conducted provide the opportunity to examine the kinetic aspects of the leaching of acetic acid. As shown in Figure 2, the release of acetic acid from material C2 is virtually instantaneous especially for the irradiated filmswhile the acetic acid release from material C1 is slower.
Rather, these additional extractables are similar to acetic acid in terms of its high aqueous solubility, its defined total pool in the test materials, and its distribution in the test materials. The experiments whose results are considered in this manuscript are described in greater detail in reference