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Sanitary napkins are technical textile products that women use to hygienically collect menstrual fluids when they are menstruating. Because sanitary napkins must simultaneously fulfil a number of end-use requirements, they have layered constructions. Through the Unnat Bharat Abhiyan, Surat, India, this study explores the eco-friendly (organic material) sanitary napkin production facility in the village of Bhatlai in the Gujarat province of India and identifies an issue. With eco-friendly organic sanitary products, bioburdens are a big problem. The Unnat Bharat Abhiyan accepts recommendations and improvements relating to sterility in a sanitary manufacturing unit after bioburden testing is conducted using various approaches outlined by Sanitary Napkins - Specification (IS 5405:2019). This study seeks to develop sanitary napkins that are sterilized and have no bioburden to replace SAPs (super absorbent polymer) with an ecologically friendly biopolymer that provides competent performance and characteristics to rural women of India living near or below poverty line. [ABSTRACT FROM AUTHOR]

The recent FDA approvals of Rebyota™ and Vowst™ represent landmark milestones within the burgeoning field of live microbiota-based products. Future microbiota-based treatment approaches also hold significant promise for treating patients with a myriad of diseases and disorders, yet substantial hurdles hinder their development and utilization. Foremost, existing regulatory frameworks governing live biotherapeutic product (LBP) manufacturing development have notable gaps, requiring comprehensive expansion and refinement. Along with regulatory challenges, hurdles remain in the optimization and validation of analytical methodologies essential for characterizing LBPs, including for microbial identification, potency, and bioburden. To address these challenges, Microbiome Therapeutics Innovation Group (MTIG) spearheaded collaborative efforts, engaging industry leaders and the FDA in discussions aimed at catalyzing improvements in LBP analytics and refining the current regulatory landscape. Extrapolating on feedback from these discussions, this review highlights challenges and identifies critical gaps. Specific recommendations for future regulatory guidance are proposed, as are recommendations for interactions that developers can take now with regulatory agencies to support the development of maturing guidance. Key analytical factors to consider in LBP development are reviewed, highlighting strengths and weaknesses of various methodologies. Collaboration among regulatory and government agencies, industry, and academia, facilitated by coalitions like MTIG, will be instrumental in ushering the microbiota-based therapeutics field into the next phase of approvals and advancements, ultimately benefiting patients. [ABSTRACT FROM AUTHOR]

Negative Pressure Wound Therapy (NPWT) has been widely adopted in wound healing strategies due to its multimodal mechanism of action. While NPWT’s positive impression on wound healing is well-established, its effect on bacterial load reduction remains equivocal. This study investigates NPWT’s efficacy in reducing bioburden using an in vitro porcine skin model, focusing on the impact of Staphylococcus aureus and Staphylococcus epidermidis. Custom-made negative pressure chambers were employed to apply varying negative pressures. Porcine skin was cut into 5 × 5 cm squares and three standardized wounds of 6 mm each were created using a biopsy punch. Then, wounds were infected with S. aureus and S. epidermidis bacterial suspensions diluted 1:10,000 to obtain a final concentration of 1.5 × 104 CFU/ml and were placed in negative pressure chambers. After incubation, bacterial counts were expressed as colony-forming units (CFU) per ml. For S. aureus at 120 hours, the median CFU, mean area per colony, and total growth area were notably lower at −80 mmHg when compared to −250 mmHg and −50 mmHg, suggesting an optimal negative pressure for the pressure-dependent inhibition of the bacterial proliferation. While analyzing S. epidermidis at 120 hours, the response to the negative pressure was similar but less clear, with the minor CFU at −100 mmHg. The influence of intermittent negative pressure on the S. epidermidis growth showed notably lower median CFU with the interval therapy every hour compared to the S. aureus control group. This study contributes valuable insights into NPWT’s influence on the bacterial load, emphasizing the need for further research to reformulate its role in managing contaminated wounds.

Bioburden detection is crucial for food, water, and biopharmaceutical applications as it can directly impact public health. The objective of this study is to develop and validate an assay and protocol for detecting bioburden on solid surfaces, as well as in water, with high sensitivity and accuracy in a rapid manner. Henceforth, a resazurin‐based assay optimized for detecting bioburden has been integrated with a previously developed portable multichannel fluorometer. The microbes were isolated from solid surfaces in different laboratory settings by swabbing technique, and stream water was collected for contamination analysis. Based on the results, the assay and protocol can successfully detect bioburden as low as 20 CFU/cm2 and 10 CFU/mL present in both surface and water samples, respectively. [ABSTRACT FROM AUTHOR]

The suspension wet media milling manufacturing process is a complex multi-unit operation, resulting in drug substance comminution to a target particle size. As a result of this complexity, microbial contamination is of paramount concern, particularly for suspensions dosed for parenteral use. This perspective sought to review the influence of (4) critical manufacturing unit operations using a quality risk management approach to better identify and articulate impact of each unit operation on bioburden viability. The manufacturing unit operations in scope included slurry compounding, deaeration, milling, and filling. Bow tie risk analysis was used as a visual gap analysis tool to evaluate if conventional controls were appropriate to detect and mitigate potential for microbial contamination. A deep dive into these unit operations clarified that mechanisms such as turbohypobiosis, cavitation during deaeration, high energy milling, and inert overlay may have an appreciable influence on bioburden viability and proliferation. The resultant analysis also explicated that endotoxin oversight must be closely monitored through barriers (input material controls, water quality controls) to minimize impact to the product and patient. The identified manufacturing unit operations were not appropriate as mitigating controls for endotoxin. The output of this article relates risk intersections for microbial contamination during wet media milling and offers insights in critical areas for intervention. [ABSTRACT FROM AUTHOR]

The microbiological quality of municipal water is of prime importance for public health and represents a prominent concern for authorities to maintain and control the bioburden level within safe limits. An appropriately functioning network must ensure the biological stability of the water distribution system throughout the way of water from the processing and purification station until reaching the ultimate consumers. The study examines methodologies used to evaluate different segments from a local distribution system of city water by examining short-term results of the total microbial count obtained from several available points of use through a one-year period. Microbial variations observed in city's water system. Autumn has the highest bioburden. Locations exceeding 10,000 CFU/100 mL threshold warrant investigation. Non-uniform distribution across the system suggests potential influence of distance, pipe type, and biofilms. Early warning system established to monitor bioburden surges. Descriptive analysis showed that six lines from 19 examined sections from the distribution system had lower dispersion in the microbiological data between minimum and maximum results than the remaining parts of the distribution pipes. Moreover, multiple comparison test outputs returned significant differences in microbiological density datasets between high-count and low-count use points. Thus, surveying the layout design of the municipal water distribution infrastructure would be crucial to restate its impact on the sanitary distribution of water. In conclusion, this refined study provides a nuanced examination of microbiological stability in municipal water distribution, offering targeted insights for effective public health management. By implementing the present assessment, public health authorities can spot and identify defective areas in the distribution system and take necessary actions to prevent or mitigate potential risks of waterborne diseases. [ABSTRACT FROM AUTHOR]

There is an increasing use of non‐medicated wound dressing with claims of irreversible bacterial binding. Most of the data are from in vitro models which lack clinical relevance. This study employed a range of in vitro experiments to address this gap and we complemented our experimental designs with in vivo observations using dressings obtained from patients with diabetes‐related foot ulcers. A hydrophobic wound dressing was compared with a control silicone dressing in vitro. Test dressings were placed on top of a Pseudomonas aeruginosa challenge suspension with increasing concentrations of suspension inoculum in addition to supplementation with phosphate buffered saline (PBS) or increased protein content (IPC). Next, we used the challenge suspensions obtained at the end of the first experiment, where bacterial loads from the suspensions were enumerated following test dressing exposure. Further, the time‐dependent bacterial attachment was investigated over 1 and 24 h. Lastly, test dressings were exposed to a challenge suspension with IPC, with or without the addition of the bacteriostatic agent Deferiprone to assess the impacts of limiting bacterial growth in the experimental design. Lastly, two different wound dressings with claims of bacterial binding were obtained from patients with chronic diabetes‐related foot ulcers after 72 h of application and observed using scanning electron microscope (SEM). Bacteria were enumerated from each dressing after a 1‐h exposure time. There was no statistical difference in bacterial attachment between both test dressings when using different suspension inoculum concentrations or test mediums. Bacterial attachment to the two test dressings was significantly lower (p < 0.0001) when IPC was used instead of PBS. In the challenge suspension with PBS, only the hydrophobic dressing achieved a statistically significant reduction in bacterial loads (0.5 ± 0.05 log colony forming units; p = 0.001). In the presence of IPC, there was no significant reduction in bacterial loads for either test dressing. When bacterial growth was arrested, attachment to the test dressings did not increase over time, suggesting that the number of bacteria on the test dressings increases over time due to bacterial growth. SEM identified widespread adsorption of host fouling across the test dressings which occurred prior to microbial binding. Therein, microbial attachment occurred predominantly to host fouling and not directly to the dressings. Bacterial binding is not unique to dialkylcarbamoyl chloride (DACC) dressings and under clinically relevant in vitro conditions and in vivo observations, we demonstrate (in addition to previously published work) that the bacterial binding capabilities are not effective at reducing the number of bacteria in laboratory models or human wounds. [ABSTRACT FROM AUTHOR]

A commercial bacterial cellulose-monolaurin wound dressing was investigated for changes in the chemical structure, mechanical strength, thermal degradation, morphology, and functional swelling properties after exposure to gamma and electron beam radiations at doses 15-50 kGy. Radiation-induced oxidation occurred as seen in the FT-IR peaks at 1720-1750 cm−1. Degradation of the cellulosic network was observed in tensile strength reduction and shift in degradation temperature to lower values. The SEM cross-section images of the irradiated dressings revealed a less dense nanostructure network compared to the non-irradiated samples while the XRD diffractograms indicated a change in lattice direction/plane. Despite these changes, irradiation caused no significant effect on the functional properties especially at 15-25 kGy doses where most biomedical devices are sterilized. All irradiated wound dressings exhibited physical integrity, increased exudate absorption, and water vapor transmission rate - properties beneficial to wound-healing functionality. The pre-selected sterilization dose of 15 kGy for each ionizing radiation was successfully verified and substantiated following ISO 11137-2:2016, hence ionizing radiation is a suitable sterilization modality for the product. Graphical Abstract [ABSTRACT FROM AUTHOR]

Historically, fuel microbiology studies have relied on culture data. Potentially relevant but unculturable bacteria were not detected. Although ATP can quantify total microbial bioburdens in fuels, it cannot differentiate among the taxa present. Quantitative PCR (qPCR) testing promises to fill this gap by quantifying targeted amplicon sequences thereby detecting both culturable and non-culturable taxa and quantifying specifically targeted taxa. In this study, fluid samples drawn from the fuel, interface and water phases of fuel over water microcosms were tested for cellular ATP concentration ([cATP]) and qPCR bioburdens. Additionally, surface swab samples from steel corrosion coupon surfaces exposed to each of these three phases were collected and tested for total ATP concentration ([tATP]) and qPCR bioburdens. Statistical relationships between ATP and qPCR bioburdens were examined. Correlation coefficients between the two variables were matrix dependent and ranged from negligible (| r |=0.2) to strong (| r |=0.7). When results were categorized into negligible, moderate and heavy bioburdens, parameter agreement was again matrix dependent. Percentage agreement between [ATP] and qPCR gene copies ranged from 11 % to 89 % - with qPCR-bioburden ratings typically being greater than ATP-bioburden ratings., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors.)

Microbiological contamination may cause microbial proliferation and consequently additional problems for pharmaceutical companies through production stoppage, product contamination, investigations of process deviations, out-of-specification results and product disposal. This is one of the major concerns of the regulatory health agencies. Microbiological load (bioburden) may represent a potential risk for patients if the sterilization process is not effective and/or due to the production of toxins. Although bioburden can be eliminated by terminal sterilization or filtration processes, it is important to monitor the amount and determine the identity and characteristics of the microorganisms present prior to final processing. The application of microorganism identification systems is crucial for identifying the type of contamination, which can be extremely useful for investigating. The aim of this study was to evaluate the profiles of microorganisms identified in bioburden assays from solutions, culture medias, and products (SCP) from a pharmaceutical industry facility. From 2018-2020, a total of 1,078 samples from 857 different lots of SCP were analyzed and isolated microorganisms were identified. A prefiltering step was included after March 2020, in order to reduce the bioburden before sterilizing filtration. Criteria for the definition and management of microorganisms identified were evaluated after an integrative bibliographic review, and three groups were proposed (critical, objectionable, and nonobjectionable microorganisms). For the samples that did not include prefiltering (n=636), 227 (35.7%) presented microbial growth. For those that included prefiltering, before prefiltering (n=221), 60.6% presented microbial growth, and after prefiltering, this value was reduced to 4.1%, which can be attributed to a contamination during the sampling or a wrong filtering. From the samples that presented microbial growth, 678 microorganisms were identified as bacteria and 59 as molds and yeasts. A total of 120 microorganisms (56 and 27 Gram-positive and negative bacteria, respectively, 31 yeasts, and six filamentous molds) could not be identified, and the remaining microorganisms were classified as objectionable (n=507; 82.2%), nonobjectionable (n=103; 16.7%) and critical (n=7; 1.1%). Most of the bioburden species (>80.0%) were considered objectionable microorganisms. A process for classification and management of bioburden analysis results based on a literature review of pathogenic and physiological characteristics of the microorganisms was proposed., (Copyright © 2024, Parenteral Drug Association.)

In the execution of its legislated responsibilities, the United States Food and Drug Administration commonly refers to standard test methods detailed in the United States Pharmacopeia (USP). Microbiological test methods (contained in general chapters) are listed in chapters <51> to <80> with details regarded as enforceable where referenced as a test method. USP <61> "Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests" is a globally harmonized chapter that has been successfully employed for the enumeration of microorganisms recoverable from nonsterile finished drug products. The content of USP <61> is not always scientifically principled nor emphatically understood by all pharmaceutical microbiologists. Consequently, misunderstanding and misapplication of USP <61> may result in analyses and assessments of microbiological quality that are flawed or erroneous. In this article, clarification is provided to assist the pharmaceutical microbiologist in the appropriate and intended use of USP <61>, including provision of details not always commonly known or understood., (© PDA, Inc. 2024.)