Single-use Bags Research Articles

#1705 Central delivery of acid concentrate for haemodialysis: a single-center experience

Abstract Background and Aims Dialysate is produced by mixing ultra-purified water with acid and bicarbonate concentrates. Acidic concentrate for hemodialysis can be supplied to the dialysis machine through single-use bags or central concentrate supply. Central delivery of acid concentrate represents an innovation in hemodialysis settings in terms of practicality and eco-sustainability as this system is able to produce and distribute ready-to-use acid dialysis concentrate without the use of acid concentrate bags. The aim of our study was to compare the amount of material (including packaging) used to supply acid concentrate using a single-use bag (3.8 L or 4.5 L) or central acid supply at the Nephrology Dialysis and Renal Transplant Unit of Azienda Ospedaliero Universitaria di Modena, Modena, Italy. In particular, we reviewed the amount of consumable material before (January-December 2019) and after the implementation of central concentrate supply (July 2022-June 2023). Lastly, a survey was delivered to all dialysis nurses who work in our dialysis Center to evaluate their feedback on central concentrate supply. Method Our center is equipped with 46 dialysis stations for patients on chronic hemodialysis that in 2019 delivered 30 000 hemodialysis treatments distributed across morning, afternoon, and evening shifts. Granumix system® (Fresenius Medical Care, Bad Homburg, Germany) was installed in 2022. It produces and distributes acid concentrate fluid with two different concentrations of K+ (2 and 3 mEq/L) and a unique concentration of Ca2+ 1.5 mmol/L (see Figure). Results The data collected in 2019 at our Dialysis Center showed that 30 000 acid bags corresponding to 121 000 L of acid concentrate fluid were used to perform hemodialysis. Utilization of bags generated 3 750 kg of pallets, 4 500 kg of plastic and 5 367 kg of boxes. Considering that approximately 10% of the acid concentrate fluid remains unused during each dialysis treatment, approximately 12 000 L of unutilized acid concentrate fluid was wasted. Following the introduction of the Granumix® system, there was a significant reduction (−80.6%) in the utilization of single-use acid concentrate bags (n = 5 805) and, consequently, in the use of boxes (n = 2 294 vs. n = 11 667) and pallets (n = 40 vs. n = 208). The centralized distribution system of acid concentrate led to a significant reduction in waste including boxed, plastic and pallets (2 642 kg vs. 13 617 kg), disposal of residual acidic solution (2 351 liters vs. 12 100 liters), and handling of materials by dialysis staff (37 522 kg vs. 158 117 kg). Another advantage of this system is the optimized usage of acid concentrate fluid. This system ensures that only the required amount of acid for a specific treatment is used, effectively minimizing waste and decreasing the production of special waste. The results of the survey (response rate 75%) documented that 79.5% of the nurses received adequate training for its use; 94.9% experienced a reduction in fatigue and 84.6% declared that had more time to dedicate to patients. Lastly, the survey showed that 96.4% of the participants were completely satisfied with the implementation of this new system. Conclusion Central delivery of acid concentrate is an innovative solution with eco-sustainable potentialities in reducing the consumable materials and workload in hemodialysis. Overall, most nurses expressed satisfaction as this system reduces dialysis staff workload and allows more time for patient care.

Characterisation of new sustainable gypsum composites with low-density polyethylene waste from single-use bags

The main objective of this research is to determine the feasibility of using Low-Density Polyethylene (LDPE) waste as secondary raw material in the production of new eco-friendly gypsum composites. For this purpose, LDPE waste in crumb form has been incorporated as a partial replacement by weight of the plaster material powder at percentages of 1%, 2% and 3%. Additionally, the gypsum binder in traditional gypsum composites has been replaced for LDPE waste in granulated form, at percentages of 2.5%, 5.0% and 7.5%. The experimental campaign has involved a detailed physical and mechanical characterisation of the gypsum compounds produced to study their potential applications in the construction sector. The results show that more efficient materials are obtained with the addition of these plastic wastes, significantly reducing bulk density and thermal conductivity coefficient compared to traditional gypsum-based materials. Additionally, a considerable reduction in capillary water absorption coefficient and open porosity has been observed. Moreover, the mechanical strengths in flexion and compression surpassed the limits established by current regulations for all the prepared mixtures. In this way, these innovative gypsum composite materials can be useful for application in the production of prefabricated elements, promoting the reincorporation of these plastic wastes, which currently present a challenge from the perspective of sustainability and circular economy.

Assessment of plastic pollution in coastal areas of Karachi: Case study of West Warf, Kemari Jetty, and Manora

This study focused on marine pollution in coastal areas of Karachi, particularly West Warf, Kemari Jetty, and Manora. The research examined the sources and quantities of waste, from boat manufacturing, export units, and local commercial activities. Stakeholder interviews were conducted to understand waste management practices and identify the key contributors to ocean litter. The results indicated that restaurants, export units, boat construction, and tourist and commuter activities were the primary sources of marine pollution. Plastic was found to be the most prevalent litter category, with LDPE (e.g., single-use bags) and polystyrene (e.g., material in floating docks) being the most common types. Additionally, multi-layer packaging, such as chip wrappers, was frequently observed in the surveyed areas. Overall, this research highlights the urgent need for improved waste management and compliance measures in coastal regions to mitigate marine pollution.

Identification of Biodegradable, Compostable or Toxic Plastic Bags with Two Beetles of the Tenebrionidae Family

Various studies have demonstrated the environmental problems caused by plastic bags (PB) made with hydrocarbons, and therefore international policies have been established to replace the use of conventional PB by biobags or compostable bags, which are designed to be biodegradable and/or composted in the environment. However, the methods used to characterize such bags are still far from being effectively assessed. This study evaluated a technique to identify biodegradable, compostable and/or toxic PB by feeding compostable bags certified by recognized institutions to larvae of the Tenebrionidae family, particularly Tenebrio molitor and Zophobas morio species. Three brands of single-use bags were studied, and the following parameters were evaluated: rate of consumption (of bags by larvae), percentage of biomass (weight increase in larvae), percentage of survival (percentage of larvae eating bags), percentage of biodegradability by evaluating the total organic carbon (TOC) in stool, and stool analysis by spectroscopy and spectrometry. The results showed differences between the rate of consumption, the EHappy bag being the most consumed; there were differences in the percentage of biomass, the EHappy bag showing less potential for biomass increase; both species showed lower survival with the Ealternative bag. TOC evaluation indicated that the WCare bag presents the highest biodegradability; the total reflectance attenuated infrared analysis showed a decrease in the representative peaks of the spectrum of PB, evidencing biodegradation; and the amount of metals in feces was found within the Maximum Permissible Limits. The two species showed a good performance, demonstrating that they can be used as a suitable and viable tool to evaluate toxicity, biodegradability and compostability.

Advancements in energy recovery from waste plastic material for sustainable environment and circular economy

Food packaging and other plastic waste measure by about 31% of global waste in terms of plastic. The major use for plastic packaging is to preserve food and make it last more and prevent it from external damages. Unfortunately, most of the plastic food packaging is used and thrown away and cannot be reused or recycled. From chocolate wrappers to chips wrappers to cloth bags, plastic packaging is used everywhere and cannot be avoided. The accumulation of waste plastic is serious threat to the environment; including pollution of the air and water and harm to wildlife and human being. One of the main reasons for the increase in plastic waste is the widespread use of disposable plastic products, such as single-use bags, bottles, and utensils. Plastic waste have a negative impact on the environment, including pollution of the air and water and harm to wildlife. Pyrolysis is one of the efficient methods to convert plastic waste into useful form of energy and solves these issues. The discussion in the current research include about the pyrolysis technology, important factors which affect the process parameters and utilization of plastic pyrolysis oil as a substitute of diesel. The paper also discusses about the challenges and future scope of pyrolysis of waste plastic.

Characterization of Seafloor Marine Litter Distribution in a Shipping Route of Ancon Bay

Marine litter on the seafloor has been increasing for several decades. Moreover, shipping routes and fishing ports are considered as affected areas with benthic macro-litter distribution. In Peru, the available information about benthic litter is limited and only originates from cleaning campaigns. Therefore, this study aimed to conduct the first scientific report about benthic macro-litter occurrence and composition distributed in a shipping route of Ancon Bay. For this purpose, a remotely operated vehicle (ROV) was used to evaluate the marine litter composition and distribution at depths between 1 and 25 m. A total of 8.8 h of video transects were recorded, and 46 litter items were identified, where plastic represented 80.4%; and industry food and single-use bags were the most frequent items. Plastic fragments and food industry bags dominated areas closer to San Francisco Grande mud sandy beach and the anchorage zone, respectively, while non-plastic items were more common in front of rocky shores. The present work emphasizes the importance of the studies about benthic marine debris for better decision-making regarding litter management. It also highlighted the usefulness of low-cost ROVs in identifying different litter items in shallow areas.

The dilemma of plastic bags and their substitutes: A review on LCA studies

Single-use bags have been restricted or banned in various parts of the world. The exploration of substitute alternatives such as reusable and biodegradable bags, and the use of other materials such as paper and cotton have been required. The Life Cycle Assessment (LCA) is the most widely accepted tool by the scientific community to make an environmental comparative study between different alternatives. In this study, the literature regarding LCA of bags was reviewed in order to find common conclusions, and a methodological guide for future studies. For each study, the type of bags considered, end of life treatments, the functional unit, the Life Cycle Impact Assessment methods, system boundaries, data used, locations and the results of the calculated environmental impacts are described and compared. Although some differences exist among the studies, in most analyses, reusable plastic bags are identified as the lower environmental impact alternative when enough reuses are considered. On average, the climate change index of reusable bags is equal to 27% of the value of the alternative with the highest impact in each study. For the end-of-life treatment scenarios, reuse and recycling show greater environmental benefits compared to composting, landfilling or incinerating, regardless of energy recovery. Open challenges are discussed, where several authors agree with the requirement of the development of a new index to quantify the consequences of plastic leakage into the environment.

Monitoring of peroxide in gamma irradiated PE/EVOH/PE multilayer film using methionine probe

Methionine oxidation is used as a proxy to model the gamma radiation induced changes in single-use bags. These changes can be the formation of acids, radicals and hydroperoxides due to the irradiation of the multilayer film the single use bag is made from. Biopharmaceutical multilayer polyethylene bags irradiated from 0 to 260 kGy and aged from 0 to 36 months were filled with a methionine solution to follow the oxidation of methionine. Methionine sulfoxide was measured using high performance liquid chromatography after 21 days of storage. The maximum methionine sulfoxide concentration detected after 21 days of storage was analyzed through a design of experiments. The results to the design of experiments were considered to obtain the desirability domain for the optimization of the conditions of use for the single-use bags, limiting the oxidation of methionine as well as the release of reactive species thereof.

Monitoring of Peroxide in Gamma Irradiated EVA Multilayer Film Using Methionine Probe.

In this study, the oxidation of methionine is used as a proxy to model the gamma radiation-induced changes in single-use bags; these changes lead to the formation of acids, radicals, and hydroperoxides. The mechanisms of formation of these reactive species and of methionine oxidation are discussed. With the help of reaction kinetics, the optimal conditions for the use of these single-use bags minimizing the impact of radical chemistry are highlighted. Biopharmaceutical bags gamma irradiated from 0 kGy to 260 kGy and aged from 0 to 36 months were filled with a methionine solution to follow the oxidation of the methionine. The methionine sulfoxide was measured with HPLC after different storage times (0, 3, 10, 14, 17, and 21 days). Three main results were analyzed through a design of experiments: the oxidative induction time, the methionine sulfoxide formation rate, and the maximum methionine sulfoxide concentration detected. A key aspect of the study is that it highlights that methionine is oxidized not necessarily directly by hydro(gen) peroxide but throughperacid, and likely peracetic acid. The answers to the design of experiments were considered to obtain the desirability domain for the optimization of the conditions of use for the single-use bags limiting the oxidation of methionine as well as the release of reactive species thereof.

New Jersey bans plastic and paper bags

Shoppers in New Jersey who don’t already bring reusable bags to stores would do well to begin practicing. Starting in May 2022, both plastic and paper single-use bags will be banned, along with polystyrene foam food containers and cups. Gov. Phil Murphy signed legislation for one of the strictest plastics bans in the US, S864 , into law in early November. In the law, the New Jersey Legislature determined that “it is no longer conscionable to permit the unfettered use and disposal of single-use plastics in the State.” It cited the need for the state, with nearly 9 million residents, to minimize plastic pollution entering the ocean. Lawmakers included paper bags in the ban after finding that “single-use paper carryout bags use as much or more energy and resources to manufacture and transport than single-use plastic carryout bags and contribute to harmful air emissions.” The law encourages the distribution of

Sensitivity of a PER.C6® cell line to bis(2,4-di-tert-butylphenyl)phosphate and evaluation of a new, biocompatible single-use film.

Single-use technologies have brought numerous advantages to the biopharmaceutical industry. In particular, single-use bags made from multi-layered polymeric films have been adopted for cell culture and liquid handling operations in place of traditional stainless-steel systems. Despite the advantages, leachable compounds originating from the film's materials of construction present a new challenge. In 2013, bis(2,4-di-tert-butylphenyl)phosphate (bDtBPP) was identified as a common leachable from several single-use bags that is detrimental to the growth and viability of many Chinese hamster ovary (CHO) cell lines. While much work has been completed to characterize CHO cell sensitivity to bDtBPP, little has been done to characterize its impact on other important production cell lines, particularly PER.C6®. This publication investigates inconsistent cell growth observed in a PER.C6® cell line during bioprocess development. The growth inhibition was linked to leachable migration from Bioclear™ 10, a single-use film from Cytiva (formerly GE Healthcare) that was used for cell expansion. It was shown that the PER.C6® cells displayed a sensitivity to bDtBPP, comparable to that observed in sensitive CHO cell lines. Finally, biocompatibility of PER.C6® with Cytiva's new Fortem film was evaluated, demonstrating that Fortem™ film is a suitable single-use technology for culturing PER.C6® cells.

Life cycle assessment of plastic grocery bags and their alternatives in cities with confined waste management structure: A Singapore case study

Plastic grocery bags are one of the most ubiquitous single-use packaging products. Recently, ‘eco-friendly’ options of plastic grocery bags have gained traction such as kraft paper, cotton, biodegradable, and reusable polypropylene non-woven bags. However, the impact of using various grocery bags in cities with dense population, well-developed infrastructure and thermal treatment as an end-of-life waste management option has been insufficiently documented. In this study, commonly found single-use (HDPE, biodegradable plastic, kraft paper) bags and reusable (cotton, polypropylene non-woven) bags were considered for the life cycle assessment (LCA). The usage characteristics (reusability, dimensions, carrying capacity) of bags, the production process (raw materials extraction, production processes), and emissions were determined as the significant factors contributing to the negative environmental impacts. In a model city with confined waste management, the assessment determined that the reusable polypropylene non-woven bag (PNB) caused the least overall negative environmental impacts when there are 50 instances of reuse, followed by single use HDPE plastic bag (HPB). The global warming potential (excluding biogenic carbon) was 14, 81, 17 and 16 times higher for HDPE plastic, kraft paper, cotton woven and biodegradable polymer bags, respectively, when compared to PNB. Moreover, kraft paper or cotton woven bags demonstrated the highest negative impacts for the impact categories including abiotic fossil depletion, freshwater-, marine- and terrestrial-ecotoxicities, human toxicity, acidification and eutrophication potentials. Further, sensitivity analysis indicated that the inflexion point for the PNB was minimum 4 reuses to avoid emission equivalent to the HPB. Singapore was adopted as the model city with confined waste management structure that imports most of the grocery bags, either as finished goods or as raw materials. Through comprehensive insights based on the new outlook of the integrated LCA model (cradle-to-grave) that included full-scale transportation component, the usage of the real case data from a city to develop the life cycle inventory, and consideration of the existing grocery bags options, the environmental assessment along with critical evaluation was conducted.

Degradation of bio-based and biodegradable plastics in a salt marsh habitat: Another potential source of microplastics in coastal waters

Degradation of bio-based (polylactic acid [PLA] cups, Mater-Bi® [MB] bags) and biodegradable plastics (biodegradable extruded polystyrene [bioPS] plates, biodegradable high density polyethylene [bioHDPE] bags) were compared to conventional plastics (recycled polyethylene terephthalate [rPET] cups, HDPE bags, extruded PS plates) in a salt marsh over a 32-week period. Following 4 weeks, biofilm developed on all plastics, resulting in an increased weight and concomitant decrease in UV transmission for most plastics. All plastics produced microplastic particles beginning at 4 weeks, with single-use bags producing the most microplastics over the 32-week period. At 32 weeks, SEM revealed microcracks and delamination for all plastics except PLA and MB, the latter of which degraded through embrittlement. IR spectral analysis indicated degradation for all plastics except PLA. Results suggest that degradation rates of bio-based and biodegradable plastics vary widely, with MB bags and bioPS plates demonstrating the greatest degradation, while PLA cups demonstrated the least degradation.

Identification of additives in polymers from single-use bioprocessing bags by accelerated solvent extraction and ultra-high performance liquid chromatography coupled with high-resolution mass spectrometry

Single-use technologies are increasingly used in biopharmaceutical manufacturing. Despite their advantages, these plastic assemblies draw concern because they are a potential source of contamination due to extractable and leachable compounds (E&Ls). Characterising E&Ls from such materials is a necessary step in establishing their suitability for use. Therefore, there is an urgent need for sensitive methods to identify and quantitatively assess compounds in plastic materials.Accelerated solvent extraction (ASE) is a powerful technique that can be reliably used for this purpose. In this study, ASE followed by liquid chromatography and Orbitrap-based High Resolution Accurate Mass (HRAM) mass analysis was found to be an efficient and versatile method for the determination of additives in different multilayer polymer systems from single-use bags. ASE optimisation was performed using a design of experiments approach. The type of solvent, temperature, swelling agent addition, static time and number of cycles were the selected variables. Optimum conditions were dependent on the type of plastic film. Ethyl acetate and cyclohexane were selected individually as optimum solvents. Optimum temperatures were 90–100 °C. Pressure was set at 1500 psi and extraction time was 30 min in 2 cycles. Swelling agent addition was necessary with polar extraction solvents. More than 100 additives and degradation products were confidently identified by HRAM MS. Correlations between the type and levels of identified additives and the type of polymer system were established. In addition, degradation behaviour and pathways for some additives can be addressed.

Photocatalytic Conversion of Waste Plastics into C2 Fuels under Simulated Natural Environment Conditions.

Reported here is the first highly selective conversion of various waste plastics into C2 fuels under simulated natural environment conditions by a sequential photoinduced C-C cleavage and coupling pathway, where single-use bags, disposable food containers, food wrap films, and their main components of polyethylene, polypropylene, and polyvinyl chloride can be photocatalytically transformed into CH3 COOH without using sacrificial agents. As an example, polyethylene is photodegraded 100 % into CO2 within 40 h by single-unit-cell thick Nb2 O5 layers, while the produced CO2 is further photoreduced to CH3 COOH. Various methods and experiments disclose that O2 and . OH radicals trigger the oxidative C-C cleavage of polyethylene to form CO2 , while other investigations show that the yielded CH3 COOH stems from CO2 photoreduction by C-C coupling of . COOH intermediates. This two-step plastic-to-fuel conversion may help to simultaneously address the white pollution crisis and harvest highly valuable multicarbon fuels in natural environments.

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

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.

Single-Use System Integrity I: Using a Microbial Ingress Test Method to Determine the Maximum Allowable Leakage Limit (MALL).

An aerosol microbial ingress test was specifically designed and used to create a predictive model in order to determine the maximum allowable leakage limit (MALL) of single-use systems (SUSs). The MALL is defined as the greatest leak size that does not pose any risk to the product. The procedure involved taking test samples of film material from single-use bags. As test samples, an ethylene vinyl acetate multilayer film (300 μm thick) and a polyethylene multilayer film (400 μm thick) were cut into 50 mm patches. Artificial defects of 1-100 µm were laser-drilled in the middle of each film patch. The patch was assembled on a holder and properly sealed. The test units were filled aseptically with culture media and placed inside an aerosol chamber. Various pressures were applied to the test unit to simulate the constraints that single-use systems may be subject to under real-world conditions. After an aerosolization cycle with spores of Bacillus atrophaeus, a minimum concentration of 106 CFU/cm2 was reached on the film surface. The test units were incubated for 14 days at 30°C-35°C and visually inspected for bacterial ingress. Thirty samples per defect size were tested. Logistic regression was used to indicate the MALL for a single-use system according to the required risk level. With this method, the probability of the occurrence or absence of ingress for a specific defect size was reported according to the experimental data. In addition to physical parameters, such as the pressure applied and the film material, the effect of the probabilistic nature of the microorganisms in determining the MALL is considered. Although finding an experimental model to predict the MALL for real-life process conditions was the ultimate objective, this paper also presents the microbial ingress test data obtained so far for two extreme conditions. Potential constraints, such as vibration, shock, acceleration, liquid movement, and pressure differentials, observed during normal usage were simulated using two extreme differential pressures, 0 mbar and 300 mbar. The estimated MALL for typical use-case conditions are 10-20 µm for storage applications and 2-10 µm for shipping conditions. The microbial integrity test method used in this article was able to detect bacterial ingress down to 3 µm defect size.LAY ABSTRACT: As use of single-use systems (SUSs) is increasingly expanding into all process steps of commercial manufacturing, integrity failure can significantly impact drug safety, availability, and costs. Consequently, growing industry scrutiny on single-use system integrity (SUSI) is raising the need to develop good science behind reliable determinations of liquid leakage and microbial ingress as well as the appropriate physical integrity testing technologies. In the current study, microbial ingress testing by the aerosol method is used to determine the maximum allowable leakage limit (MALL) for SUSs. To define the MALL, it is generally assumed that a system or product will not show any microbial ingress or leakage at a certain defect size. Statistical analysis of the experimental data in this study indicated the MALL with probability at a certain defect size for each system. As a result, the method studied provides a more accurate way of predicting ingress and increasing safety down the line for drug manufacturers and patients alike.

Banning Plastic Shopping Bags: Raising Environmental Consciousness on National Level

This paper is centered around social learning theory principles and intends to demonstrate the use of these principles through a proposed ban of single-use plastic shopping bags. The ban would be an effort to raise environmental awareness in U.S. society. This paper explores the current literature across several connected topics: the harm that plastic shopping bags cause to our environment; the way in which a ban of these bags could improve environmental awareness, and as a by-product, raise efforts; and the best alternative to these single-use bags: jute bags. Furthermore, this paper explores how these efforts could become realized through the use of governmental incentives designated for corporations who implement these changes. Lastly, this paper explores possible positive long-term effects of this implementation and potential problems within these proposals.

Analyzing what single-use bags release

The biotech industry is beginning to replace metal vats in the manufacturing process with single-use plastic bags. But concerns remain about whether compounds could leach out of the films inside the bags. Such compounds could negatively affect cells during biomanufacturing or persist through purification processes and end up in protein drug formulations, causing a potential risk to patients. A team led by Jonathan Bones of the National Institute for Bioprocessing Research & Training, in Ireland, has measured the compounds released by 34 single-use bags from five suppliers (Anal. Chem. 2018, DOI: 10.1021/acs.analchem.8b01208). The team looked for two kinds of molecules: extractables, which represent all possible compounds that could be released, and leachables, which would be present only under normal conditions. To identify the extractables, the researchers extracted bag films with four solvents chosen to represent potential worst-case scenarios in biomanufacturing. They obtained the leachables by using c...

Large-Scale Assessment of Extractables and Leachables in Single-Use Bags for Biomanufacturing.

Single-use technologies (SUTs) are widely used during biopharmaceutical manufacture as disposable bioreactors or media and buffer storage bags. Despite their advantages, the risk of release of extractable and leachable (E&Ls) substances is considered an important drawback in adopting disposables in the biomanufacturing process. E&Ls may detrimentally affect cell viability or productivity or may persist during purification and present a risk to the patient if remaining in the final drug product. In this study, 34 plastic films from single-use bags (SUBs) for cell cultivation were extracted with selected solvents that represent reasonable worst-case conditions for most typical biomanufacturing applications. SUBs were incubated at small-scale under accelerated-aging conditions that represented standard operational conditions of use. Leachables analysis was performed following dispersive liquid-liquid microextraction (DLLME) for analyte preconcentration and removal of matrix interference. Resulting extracts were characterized by GC-headspace for volatiles, high resolution GC-Orbitrap-MS/MS for semivolatiles, high resolution LC-Orbitrap-MS/MS for nonvolatiles, and ICP-MS for trace elemental analysis. Multivariate statistical analysis of the analytical data revealed significant correlations between the type and concentration of compounds and bags features including brand, manufacturing date and polymer type. The analytical data demonstrates that, over recent years, the nature of E&Ls has been altered due to the implementation of manufacturing changes and new types of polymers and may change further with the future advent of regulations that will limit or ban the use of certain raw materials and additives. The broad E&L database generated herein facilitates toxicological assessments from a biomanufacturing standpoint and provides practical guidelines for confident determination of E&Ls to enable screening and elimination of nonsatisfactory films for single use bioprocessing.