The Ubiquitous Issue of Cross-Mass Transfer: Applications to Single-Use Systems

Abstract

The leaching of chemicals by materials has been integrated into risk management procedures of many sectors where hygiene and safety are important, including food, medical, pharmaceutical, and biotechnological applications. The approaches focus on direct contact and do not usually address the risk of cross-mass transfer of chemicals from one item or object to another and finally to the contacting phase (e.g., culture medium, biological fluids). Overpackaging systems, as well as secondary or ternary containers, are potentially large reservoirs of non-intentionally added substances (NIAS), which can affect the final risk of contamination. This study provides a comprehensive description of the cross-mass transfer phenomena for single-use bags along the chain of value and the methodology to evaluate them numerically on laminated and assembled systems. The methodology is validated on the risk of migration i) of ϵ-caprolactam originating from the polyamide 6 internal layer of the overpackaging and ii) of nine surrogate migrants with various volatilities and polarities. The effects of imperfect contacts between items and of an air gap between them are particularly discussed and interpreted as a cutoff distance depending on the considered substance. A probabilistic description is suggested to define conservative safety-margins required to manage cross-contamination and NIAS in routine.

X‐ray sterilization of biopharmaceutical manufacturing equipment—Extractables profile of a film material and copolyester Tritan™ compared to gamma irradiation

“…The compound caprolactam was detected and was unambiguously assigned to the packaging material and is not reported in the summary table. 44 The monomer CHDM, and its dehydrated product 4‐methylene‐cyclohexanemethanol (CAS 1004‐24‐6), were detected at low concentrations (0.1 μg/mL). Trimethylpentenol, which is most likely formed from the TMCD after dehydratization, was overserved at approximately 1.0 μg/mL in both ethanol extracts.…”

“…This was expected since no additives such as stabilizers are required and used in the material and that no radiolysis The compound caprolactam was detected and was unambiguously assigned to the packaging material and is not reported in the summary table. 44 The monomer CHDM, and its dehydrated product oligomers, such as the cyclic dimer and trimers were included in the suspected target screening using the Waters instrument software UNIFI™. Such oligomers are always formed in polymerization reactions to polyesters.…”

FitNESS: An E-Learning Platform to Design Safe and Responsible Food Packaging

“…29 These crises highlight a critical oversight: the misconception that permanent contact between packaging and food is necessary for contamination to occur. This has led to a systematic underestimation of risks, particularly for dry foods and in cases of cross-contamination via the vapor/gas phase within packaging systems 30,31 or during material collection for recycling. 32,33 Concurrently, tightening environmental policies is promoting deterrence strategies that might, in the short term, pose challenges to our food production system.…”

In Silico Prediction of Food Properties: A Multiscale Perspective

“…• Heat capacities Brewer and Peltzer (2019) Studies are scarce, in particular in foods and biological products Nguyen et al (2013), Nguyen et al (2017c), Nguyen et al (2019) (Continued on following page) called microscale. ϵ d ℓ represents the ratio between the microscale d and the macroscale ℓ (see Figure 2A).…”