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PDA Journal of Pharmaceutical Science and Technology

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https://www.readbyqxmd.com/read/29242394/a-qrm-discussion-of-microbial-contamination-of-non-sterile-drug-products-using-fda-s-and-ema-s-warning-letters-between-2008-and-2016
#1
Ana M C Santos, Mara S Doria, Luis Soares, António J Almeida, José C Menezes
Microbial quality control of non-sterile drug products is a concern to regulatory agencies and the pharmaceutical industry since the 1960's. Despite being an old challenge to companies, microbial contamination still affects a high number of manufacturers of non-sterile products. Consequences go well beyond the obvious direct costs related to batch rejections or product recalls, as human lives and a company's reputation are significantly impacted as well if such event occurs. To better manage this type of events and establish effective mitigation strategies, it is necessary to understand the microbial hazards involved in the manufacturing processes of non-sterile drug products, be able to evaluate their potential impact on final product quality and apply mitigation actions ...
December 14, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/29242393/a-risk-index-and-data-display-for-process-performance-in-the-pharmaceutical-industry
#2
Bert Gunter, Daniel Coleman, Aaron Goerke, Theodoro Koulis, Jens Lamerz, Yiming Peng
We propose a new index and graphical display for quantifying and visualizing process performance in the pharmaceutical industry. These tools can provide management a comprehensive, high level overview of the process performance of a global manufacturing network suitable for risk ranking, by which is meant: identifying those processes at greatest risk of failing to meet specifications, and prioritizing resources to drive continuous process improvement. Our index, like others currently in use, compares the observed variation of CQAs -- Critical Quality Attributes -- to their specifications...
December 14, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/29242392/benchmarking-of-sterilizing-grade-filters-with-liposome-filtration
#3
Thomas Loewe, Ramesh Mundlamuri, Thomas Loewe, Ashok Mundrigi, Sebastian Handt, Bhuwan Singh
Cytotoxic drugs can be encapsulated in liposomes vesicles, which act as drug delivery vehicles and reduce the risk of exposure of drug to healthy cells(1). The sterility of such liposome solutions is typically ensured using 0.2μm rated sterilizing grade membranes, but due to the high viscosity and low surface tension of these formulations, they can cause pre-mature blocking and increased risk of bacterial penetration through a 0.2μm sterilizing grade membrane(2). The low surface tension of liposome solutions affects the contact angle with membrane and reduces bubble point leading to bacterial penetration through the membrane...
December 14, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/29242391/method-verification-requirements-for-an-advanced-imaging-system-for-microbial-plate-count-enumeration
#4
David Jones, Tony Cundell
Technical Abstract: The Growth Direct™ System that automates the incubation and reading of membrane filtration microbial counts on soybean-casein digest, Sabouraud dextrose and R2A agar differs only from the traditional method in that micro-colonies on the membrane are counted using an advanced imaging system up to 50% earlier in the incubation. Based on the recommendations in USP <1223> Validation of New Microbiological Testing Methods, the system may be implemented in a microbiology laboratory after simple method verification and not a full method validation...
December 14, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/29158288/time-dependent-testing-evaluation-and-modeling-for-rubber-stopper-seal-performance
#5
Qingyu Zeng, Xia Zhao
Sufficient rubber stopper sealing performance throughout the entire sealed product life cycle is essential for maintaining container closure integrity (CCI) in the parenteral packaging industry. However, prior publications have lacked systematic considerations for the time-dependent influence on sealing performance that results from the viscoelastic characteristics of the rubber stoppers. In this paper, we report results of an effort to study these effects, by applying both compression stress relaxation (CSR) testing and residual seal force (RSF) testing for time-dependent experimental data collection...
November 20, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/29158287/development-of-a-premium-quality-plasma-derived-ivig-iqymune%C3%A2-utilizing-the-principles-of-quality-by-design-a-worked-through-case-study
#6
Philippe Paolantonacci, Philippe Appourchaux, Béatrice Claudel, Monique Ollivier, Richard Dennett, Laurent Siret
Polyvalent human normal immunoglobulins for intravenous use (IVIG), indicated for rare and often severe diseases, are complex plasma-derived protein preparations. A Quality by Design (QbD) approach has been used to develop the LFB new generation IVIG, targeting a high level of purity to generate an enhanced safety profile while maintaining a high level of efficacy. A modular approach of QbD was implemented consisting of five consecutive steps to cover all the stages from the product design to the final product control strategy...
November 20, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/29158286/what-is-data-integrity
#7
Anil K Rattan
Data integrity has recently been in the regulatory agencies limelight. It is primarily due to increased number of inspections findings related to data integrity. Regulatory agencies have published many guidelines for industry to follow starting from 1963. AT that industry was using the completely paper-based system but due to the technology advancement, we are in electronic age. Most of the pharmaceutical industry is operating in the hybrid mode. It is clear that it started with basic regulations, then 21 CFR Part 11 and now ALCOA plus...
November 20, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/29223970/sea-changes
#8
EDITORIAL
Govind Rao
No abstract text is available yet for this article.
November 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/29030532/mechanistic-investigation-on-grinding-induced-subvisible-particle-formation-during-mixing-and-filling-of-monoclonal-antibody-formulations
#9
Benson Gikanga, Ada Hui, Yuh-Fun Maa
Processing equipment involving grinding of two solid surfaces has been demonstrated to induce subvisible particle (SvP) formation in monoclonal antibody (mAb) drug product manufacturing processes. This study elucidated potential stress types associated with grinding action to identify the stress mechanism responsible for SvP formation. Several potential stress types can be associated with the grinding action, including interfacial stresses (air-liquid and liquid-solid), hydraulic/mechanical shear stress, cavitation, nucleation of stressed protein molecules, and localized thermal stress...
October 12, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/29030531/impact-of-formulation-variables-on-silicone-oil-distribution-and-functionality-of-prefilled-syringe-system
#10
Galen H Shi, Sharon L Shinkle, Ganapathy Gopalrathnam, Xia Dong, Jeffrey D Hofer, Eric C Jensen, Natarajan Rajagopalan
The interior surface of prefilled syringes is typically coated with silicone oil for lubrication to aid in free plunger movement. This article discusses the impact and interaction of formulation variables with silicone oil within the interior surface of the barrel. Characterization techniques including syringe glide force, break loose force, ZebraSci imaging, contact angle, ICP, and RapID were used in assessing the interactions. Data indicate formulation variables of pH, buffer and tonicity agent type and concentration and surfactant can impact silicone oil distribution of prefilled syringes leading to changes in functional properties of the syringe over time...
October 12, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/29030530/quality-of-medicines-in-portugal-a-retrospective-review-of-medicine-recalls-2005-2015
#11
Ana Reis, Bruna Berardo, Rui Loureiro
INFARMED, the Portuguese national health authority, alerts the general public and healthcare professionals about quality or safety issues detected in health products. The present study analyses substandard medicines recalls in Portugal between 2005 and 2015. All 338 alerts for medicine recalls were analysed, which represents a total of 378 drugs withdrawn. Despite the fact that the total number of medicine alerts has increased during the past decade, the number of actual medicine recalls remained relatively constant...
October 12, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/29030529/microbiological-test-data-assuring-data-integrity
#12
Edward Charles Tidswell, Tim Sandle
Marketed drugs and devices possess specifications including critical microbiological quality attributes purposed to assure efficacy and patient safety. These attributes are legislated requirements intended to protect the recipient patient. Sampling, microbiological testing, interpretation of data for final products, raw materials and intermediates all contribute to a cohesive assessment in the assurance of finished product quality. Traditional culture-based microbiological methods possess inherent and unavoidable variability, recognized by the compendia and which might lead to erroneous conclusion pertaining to product quality...
October 12, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/29030528/real-time-pcr-detection-of-burkholderia-cepacia-in-pharmaceutical-products-contaminated-with-low-levels-of-bacterial-contamination
#13
Luis Jimenez, Theranda Jashari, Jenifer Vasquez, Stephanie Zapata, Joy Bochis, Margarita Kulko, Victoria Ellman, Matthew Gardner, Tina Choe
A Real-Time (RT) PCR assay was developed to detect Burkholderia cepacia in pharmaceutical products contaminated with low levels of bacterial contamination. Different pharmaceutical suspensions were artificially contaminated with B. cepacia, Escherichia coli, Staphylococcus aureus, and Bacillus megaterium. After a 24-hour incubation in TSB with Tween 20, samples were streaked on mannitol salt, phenyl ethyl alcohol, eosin methylene blue, MacConkey, and pseudomonas isolation agar. Microbial DNA was extracted from each sample by using a Tris-EDTA, proteinase K, Tween 20 buffer...
October 12, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/29030527/holistic-considerations-in-optimizing-a-sterile-product-package-to-ensure-container-closure-integrity
#14
Fran L DeGrazio
A new major chapter dealing with container closure integrity (CCI) was released by the United States Pharmacopeial Convention (USP). Chapter <1207> provides a significant amount of education and guidance concerning test methodologies to prove that a system is integral and safe for use. The test method used is only one of the major considerations in approaching the challenge of proving an integral system. This paper takes a holistic review of all the major considerations needed in qualifying a new vial system for container closure integrity...
October 12, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/29030526/guidelines-for-risk-based-changeover-of-biopharma-multi-product-facilities
#15
Rob Lynch, David B, Kathleen Bellorado, Peter Canisius, Douglas Heathcote, Alan Johnson, Ned Wymann, Derek Willison-Parry
In multi-product Biopharma facilities, the protection from product contamination due to the manufacture of multiple products simultaneously, is paramount to assure product quality. To that end, the use of traditional changeover methods (elastomer change-out, full sampling, etc.) have been widely used within the industry and have been accepted by regulatory agencies. However, with the endorsement of Quality Risk Management , the use of risk based approaches may be applied to assess and continuously improve established changeover processes...
October 12, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28928294/factors-affecting-reduction-of-reference-endotoxin-standard-activity-caused-by-chelating-agent-detergent-matrices-kinetic-analysis-of-low-endotoxin-recovery
#16
Masakazu Tsuchiya
Reduction of reference standard endotoxin (RSE) activity was kinetically analyzed under low endotoxin recovery (LER) conditions, and was considered as an apparent first-order reaction. Temperature, pH, and salt concentrations affected the rates of reduction of RSE activity. Temperature appeared to be the most important factor affecting LER. Components of LER matrices, such as citrate and polysorbate 20 showed similar LER effect at concentrations commonly used. Phosphate concentrations showed negative correlation against the half-life of RSE activity in solutions containing phosphate buffer and polysorbate 20...
September 19, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28928293/comparison-of-a-lyophilized-drug-product-to-other-solid-and-liquid-media-for-the-extraction-of-elastomeric-oligomers-from-a-butyl-rubber-stopper
#17
Steven A Zdravkovic
Lyophilization is commonly used to extend the shelf life of pharmaceutical products which are otherwise unstable when stored as a liquid formulation. However, the ability of a lyophilized drug, or other solid medium, to leach or extract substances from a pharmaceutical packaging material is not well characterized. To provide insight into this area of uncertainty, the extraction properties of a lyophilized drug product, the lyophilized drug product reconstituted in water, and several other solid and liquid media of varying polarity were determined using a glass vial with a butyl rubber stopper as a representative pharmaceutical packaging system...
September 19, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28928292/elastomer-change-out-justification-for-minimizing-the-removal-of-elastomers-in-order-to-prevent-cross-contamination-in-a-multiproduct-facility
#18
Michael Parks, Niamh O'Dwyer, Jeremy Bollinger, Alan Johnson, Brian Goss, Ned Wyman, Adeyma Arroyo, Joseph Wood, Derek Willison-Parry
The primary objective of any Biopharmaceutical Product Changeover (PCO) program is to employ control strategies before, during, and after the manufacturing process, as well as from the beginning of the lifecycle approach for the equipment and validation, which will minimize the opportunity for cross- contamination when switching between products. Evaluation of the need for an Elastomer Change Out (ECO) should be considered as a segment of an overall changeover assessment. Lifecycle systems (e.g. Preventive Maintenance (PM), Cleanability Coupon Testing, Good Engineering Practices, etc...
September 19, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28928291/inhibiting-sterilization-induced-oxidation-of-large-molecule-therapeutics-packaged-in-plastic-parenteral-vials
#19
Jeffrey R Vieregg, Steven J Martin, Adam P Breeland, Christopher M Weikart, Matthew V Tirrell
For many years, glass has been the default material for parenteral packaging, but the development of advanced plastics such as cyclic olefin polymers (COP) and the rapidly increasing importance of biologic drugs have provided new choices, as well as more stringent performance requirements. In particular, many biologics must be stored at non-neutral pH, where glass is susceptible to hydrolysis, metal extraction, and delamination. Plastic containers are not susceptible to these problems, but suffer from higher gas permeability and a propensity for sterilization-induced radical generation, heightening the risk of oxidative damage to sensitive drugs...
September 19, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28928290/enhancing-patient-safety-through-the-use-of-a-pharmaceutical-glass-designed-to-prevent-cracked-containers
#20
Robert A Schaut, Kyle C Hoff, Steven E DeMartino, William K Denson, Ronald L Verkleeren
An essential role of packaging material for the storage and delivery of drug products is to provide adequate protection against contamination and loss of sterility. This is especially important for parenteral containers, as lack of sterility or contamination can result in serious adverse events including death. Nonetheless, cracked parenteral containers are an important source of container integrity failures for injectable drugs and pose a serious risk for patients. Despite significant investments in inspection technology, each year many injectable drugs are investigated and recalled for sterility risks associated with cracked borosilicate containers...
September 19, 2017: PDA Journal of Pharmaceutical Science and Technology
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