PDA Journal of Pharmaceutical Science and Technology最新文献

{"title":"Determination of Trace Nitrosamines in Plastic Pharmaceutical Packaging Materials.","authors":"Lukas Jost, Frank Sprau, Lukas Thörner, Annie Wan, Payden Trujillo, Shiwei Zhou, Lucas Shaner, Ethan Li, Bilig Sechin, Lars Gläser, David Young, Percy Kampeis, Weichun Yang","doi":"10.5731/pdajpst.2025-000072.1","DOIUrl":"https://doi.org/10.5731/pdajpst.2025-000072.1","url":null,"abstract":"<p><p>Nitrosamines are classified as probable (IARC Group 2A) or possible (IARC Group 2B) human carcinogens, capable of inducing tumors even at very low concentrations (nanogram per liter levels). Regulatory considerations specifically affect Large Volume Parenteral (LVP) products due to the high application volume combined with very low allowable intake limits. These compounds have already attracted significant attention for elastomer materials like rubber. A recent FDA communication highlighted the particular importance of infusion bags, given their unique nature. In this study, over 300 batches of plastic materials, used for LVP packaging, were tested and trace levels of nitrosamines at ng/L scale were detected in several plastic granules and films. These results indicated the importance of nitrosamine profiling during raw material qualifications for LVP products.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2026-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147474969","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pinch Force Endurance and Usability Considerations for Pre-filled Syringe Designs Used by Chronic Obstructive Pulmonary Disease Patients.","authors":"Xueke Wang, Jaclyn Baron, Joanna So, Laura Morton, James Hoare, Julian Dixon, Sherri Biondi","doi":"10.5731/pdajpst.2025-000049.1","DOIUrl":"https://doi.org/10.5731/pdajpst.2025-000049.1","url":null,"abstract":"<p><p><b>Background</b> Prefilled syringes (PFS) are commonly used for self-administered injectable drugs, particularly for chronic conditions. A critical design factor is the injection force needed to depress the plunger, which varies by drug viscosity and syringe mechanics. This is especially important for patients with potential strength limitations. Human factors studies help evaluate these physical demands to ensure PFS can be used safely and effectively across diverse users. Assessing both maximum force capabilities and endurance provides key insights for optimizing syringe design and minimizing patient discomfort.<b>Objectives</b> This study evaluated Chronic Obstructive Pulmonary Disease (COPD) patients' experience with PFS samples of varying injectability (injection force and duration) and measured pinch force endurance-an indicator for PFS physical demand. Those insights aimed to guide PFS design for users with strength limitations.<b>Methods</b> 42 COPD patients performed simulated injections using three PFS samples (28N, 38N, 47N force) and rated perceived demand. They also gripped a surrogate PFS device at 28N and maximum force to measure endurance. Data predicted the 5th percentile pinch force endurance for COPD patients.<b>Results</b> The estimated COPD patients' 5th percentile pinch force endurance at 28N was 16 seconds, while their maximum pinch force endurance was around 4.4 seconds. Males pinched and held 28N longer than females, but no gender difference was observed at the maximum force. Endurance decreased as required force approached maximum capacity (consistent with Rohmert's Curve).<b>Conclusions</b> PFS usage can be challenging for users with strength limitations. A 28N force was sustainable for 16 seconds for 95% of COPD patients. Developers should minimize injection force where possible and accommodate varied injection styles-lower forces improve endurance, aiding users with reduced strength. These findings support designing accessible PFS for diverse populations.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2026-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147474086","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Does Disinfection Influence your Environmental Monitoring Data or Does your Environmental Monitoring Data Influence your Disinfection Protocols? Poster presented at PDA Microbiology Conference 2025.","authors":"Nyssa-Marie Finegan","doi":"10.5731/pdajpst.2026.26112","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26112","url":null,"abstract":"<p><p>The answer to this question is yes, and yes. The two subjects co-exist within pharmaceutical manufacturing in aseptic and sterile environments. This poster will highlight how environmental monitoring and disinfection provide continuous trending, process improvement, and final product evaluations. The processes need to be designed to identify outliers (biological and numerical) and objectionable organisms and assess cleaning protocols based on data collected. The information acquired through environmental monitoring and disinfectant efficacy studies helps to determine effective Root Cause Analysis and Corrective Action when issues with contamination are encountered. The processes, when performed and evaluated consistently will ensure that manufacturing environments are in a state of control and the products manufactured in sterile and aseptic environments are pure, safe, and effective.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 1","pages":"143-146"},"PeriodicalIF":0.0,"publicationDate":"2026-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147321911","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of The Mango System for Rapid Recovery of Microorganisms: Poster presented at PDA Microbiology Conference 2025.","authors":"Lia Jeffrey, Krzysztof Paczesny, Lara Pebley, Christopher Burgos, Lovette Jenkins, Jessica Hankins, Amy McDaniel","doi":"10.5731/pdajpst.2026.26117","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26117","url":null,"abstract":"<p><p>The Mango system was evaluated by spiking Fluid A with seven different microorganisms: Clostridium sporogenes ATCC 11437, Cutibacterium acnes ATCC 6919, Staphylococcus aureus ATCC 6538, Bacillus spizizenii ATCC 6633, Aspergillus brasiliensis ATCC 16404, Pseudomonas paraeruginosa ATCC 9027, and Candida albicans ATCC 10231. For each microorganism, two replicates were prepared on spread plates, Oasis TSA cartridges, and Mango Cartridges. Each microorganism was tested three times by three different analysts. The inoculated control plates (Oasis and spread plates onto TSA medium) were incubated at 30-35°C for 24h to 7 days. The Mango test plates were incubated for 16-160h.The study provides comparative data on the time to detection and recovery rates for the tested microorganisms. The results indicated that the Mango system consistently showed faster time to detection for aerobic organisms than traditional methods, however incubation time and conditions were microorganism-dependent, particularly for anaerobic bacteria such as C. sporogenes and C. acnes. In addition, this study showed that the rates of recovery between the Mango and traditional systems were equivalent and provides data on the filterability of different matrices. The findings indicate that the Mango system has potential to rapidly and consistently recovery microorganisms from biopharmaceutical samples.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 1","pages":"155-156"},"PeriodicalIF":0.0,"publicationDate":"2026-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147321935","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Detection of Bacillus Subtilis Endopores Using an Online Water Bioburden Analyzer: Poster presented at PDA Microbiology Conference 2025.","authors":"Kim Perkins, Amanda Picazzo, Deja Van Vliet","doi":"10.5731/pdajpst.2026.26129","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26129","url":null,"abstract":"<p><p>Bacterial endospores represent a significant challenge to the pharmaceutical industry due to their presence in the environment, resistance to many commonly used inactivation procedures, and difficulty in culturing using traditional plating methods. This may result in the inadvertent release of contaminated products that may present health concerns for the patient. As a result, the use of a bio-fluorescent particle counter (BFPC) may prove advantageous for the detection of both water-borne and air-borne spores as their detection is not dependent on traditional culturing methods. In this study, we investigate the ability of an online water bioburden analyzer (OWBA), a specific class of BFPC, to detect Bacillus subtilis spores in pharmaceutical-grade water and present the results as auto-fluorescence units (AFU's) per B. subtilis spore. The spores were a commercial grade spore preparation and were previously quantified per manufacture recommendations. The results show that the OWBA can detect B. subtilis spores with an accuracy of 1.25 AFU per spore. The limit of detection was determined to be 1 spore/mL with a linearity greater than 0.9025 up to a concentration of 100 spores/mL. This data shows that OWBA's are a rapid and effective tool for the detection of bacterial endospores in pharmaceutical waters.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 1","pages":"179-180"},"PeriodicalIF":0.0,"publicationDate":"2026-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147322013","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Understanding the Impacts and Science Behind Disinfectant Residue: Poster presented at PDA Microbiology Conference 2025.","authors":"Dan Klein","doi":"10.5731/pdajpst.2026.26120","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26120","url":null,"abstract":"<p><p>EU GMP Annex I, Section 4.36 specifically states that \"Cleaning programs should effectively remove disinfectant residues\". Although residue in controlled environments, and disinfectant residue in particular, has been around since the advent of cleanroom disinfection, there is currently an increased sensitivity towards understanding and mitigating cleanroom residues.This talk will focus on the science and microbiology of scientific residues including potential impact on rotational sporicides, the likelihood of trapping microorganisms and best practices for addressing residue in the cleanroom. The active ingredients and surfactants that make up disinfectant residue are not inherently bad, but instead key components of a complex formulation. By understanding the nature of disinfectant residue and their impacts, continuous improvements can be made to optimize an overall cleaning and disinfection program.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 1","pages":"161-162"},"PeriodicalIF":0.0,"publicationDate":"2026-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147322160","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"2025 in Review.","authors":"","doi":"10.5731/pdajpst.2026.02611","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.02611","url":null,"abstract":"","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 1","pages":"1-3"},"PeriodicalIF":0.0,"publicationDate":"2026-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147321876","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Automating Endotoxin Testing in a GMP Environment: Poster Presented at PDA Microbiology Conference 2025.","authors":"Katharina Stoib","doi":"10.5731/pdajpst.2026.26139","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26139","url":null,"abstract":"<p><p>Roche has implemented an automated endotoxin system (Lonza PyroTec® PRO) in commercial Quality Control microbiology.The key drivers for the implementation were to reduce ergonomic risk, save time and resources, increase data integrity, simplify training, digitalization, digital data flow and increase the right-first-time rate.The strategic approach to implementation and conclusions from routine testing shall be shared and discussed.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 1","pages":"199-200"},"PeriodicalIF":0.0,"publicationDate":"2026-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147321877","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Eyes on the prize: How Many Eyes are too Many for Microbiological Data Integrity? Poster presented at PDA Microbiology Conference 2025.","authors":"Christine Jackson, Stephanie Chmura Callahan, Mariana Breña, Liz Tirado","doi":"10.5731/pdajpst.2026.26116","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26116","url":null,"abstract":"<p><p>In microbiological quality control, manual observations-such as colony counts, Gram stains, and growth assessments-play a critical role in ensuring product safety and compliance. Data integrity is a key issue, with the frequency of warning letters rising annually. To determine the appropriateness of a single manual observation, it is essential to assess the risk. Cambrex conducted a formal risk assessment using the Failure Mode and Effects Analysis (FMEA) tool to evaluate manual observations in microbiology. The risk question posed was: 'What is the risk to patient safety and to cGMP decisions if a second analyst verification is not performed on manual microbial observations?'. The analysis considered key risk factors including observation complexity, analyst competency, historical deviation trends, and the potential impact on product quality and patient safety. Controls such as standardized training, competency assessments, and procedural enhancements were assessed for their ability to mitigate associated risks. Cambrex assessed the feasibility of implementing a streamlined review process in specific scenarios, ensuring compliance with Good Manufacturing Practices (GMP) while maintaining the reliability of microbiological data. Interestingly, medical device bioburden enumeration from a single manual observation was deemed low risk whereas pharmaceutical product bioburden necessitated a second analyst verification.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 1","pages":"153-154"},"PeriodicalIF":0.0,"publicationDate":"2026-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147321884","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Aseptic Process Challenges: The Threat of Underperforming Disinfectants for cGMP Applications: Poster Presented at PDA Microbiology Conference 2025.","authors":"Omar Cruz","doi":"10.5731/pdajpst.2026.26110","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26110","url":null,"abstract":"<p><p>This poster evaluates the Disinfectant Efficacy Test (DET) of various sporicidal solutions and chemistries used in an aseptic manufacturing site for parenteral and ophthalmic products, guided by USP <1072>. The assessment spans three different timeframes: the initial DET evaluation and two Corrective and Preventive Actions (CAPAs) prompted by sterility failures years later. It includes an analysis of different bacterial spore formers and the impact of disinfectant supply constraints on the market.The poster discusses the risks associated with the use of disinfectants that do not meet performance standards, emphasizing their potential threat to commercial operations. Additionally, it addresses the challenge posed by microorganisms with higher natural resistance, even when their isolation frequency is low in the environmental monitoring (EM) program.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 1","pages":"139-140"},"PeriodicalIF":0.0,"publicationDate":"2026-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147321895","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}