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Validation of a Clean-in-Place System on a Capsule Filling MachineThe aim of this study was to validate the automated clean-in-place (CIP) system installed on a capsule filling machine to determine its ability to adequately eliminate contaminants. The results obtained from the proposed cleaning validation trial showed that all the soluble tracer was removed after the washing procedure. At the end of the CIP procedure, the discharged water had the same pH, phosphate content and total organic content as the supplied water. Lack of cross-contamination in the product was also demonstrated and a recovery trial highlighted the complete elimination of the tracer from the machine.
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Scale-up trials of foam-granulation technology — high shearThe authors evaluate the scalability of foam-granulation technology using continuous foam addition in high-shear granulation equipment at the laboratory, pilot and manufacturing scales. Immediate- and controlled-release model formulations were used. Continuous and batch addition of foam were compared for the controlled-release model formulation at the manufacturing scale, and physical testing was performed on the granules and finished tablets.
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Scale-up trials of foam-granulation technology — high shearThe authors evaluate the scalability of foam-granulation technology using continuous foam addition in high-shear granulation equipment at the laboratory, pilot and manufacturing scales. Immediate- and controlled-release model formulations were used. Continuous and batch addition of foam were compared for the controlled-release model formulation at the manufacturing scale, and physical testing was performed on the granules and finished tablets.
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Developing nanoparticle drug carriersNanoparticulate drug carriers include a class of particles made of polymers or lipids that - because of their size and chemical composition -permit systemic and local treatment.
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Carriers for DPIs: formulation and regulatory challengesThe presence of very low levels of residues (including solvents) in excipients is becoming an important issue for users, and the presence of very low levels of ?non-lactose? species in DPI lactose may pose challenges to suppliers and users.
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System Optimization for In Situ Fiber-Optic Dissolution Testing: Hydrodynamic Effects, System Performance, and ApplicationsTesting of an in situ fiber-optic transmission probe demonstrates sound hydrodynamic performance and reduced stray-light limitations.
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Challenges, Considerations, and Benefits of Raw Materials TestingRaw materials testing ensures that the raw materials used in pharmaceutical products are suitable for their intended use. Conducting raw materials analysis using appropriate test methods and successfully meeting the challenges of such testing can prevent costly production problems and delays.
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Establishing a Minimum Incubation Time for Biological IndicatorsThe industry lacks an accepted method for establishing a minimum incubation time (MIT) of less than seven days for biological indicators (BIs). The authors propose an MIT method that provides a means for reproducible determination of BI grow-out time.
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Applications of Raman spectroscopy in aqueous environmentsRaman spectroscopy has become a commonly used technique for physicochemical analysis that possesses many advantages over other analytical techniques. It is a very attractive characterization tool, not least because it enables measurements in water. However, very few examples of its application in an aqueous environment exist in literature. This paper provides some recent applications of Raman spectroscopy in pharmaceutical material and process characterization when water is present.
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Monitoring of phase transformations during processing of solid dosage formsWhen a dosage form or an API is introduced to the gastrointestinal tract, or dissolution media mimicking it, a transformation from a metastable to a more stable form with lower solubility and bioavailability is possible.
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Ensuring a culture of qualityThe concept of quality should not only apply to the manufacture of the media - it should also continue throughout the product's lifetime of usage.
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The Role of 21 CFR Part 11 in the LaboratoryThe benefits of using computers and electronic records are proven in most fields of modern-day work, none more so than in laboratories. The opportunities for automation have improved productivity; the computational abilities have increased the accuracy of scientific data and allowed previously difficult or impossible analytical techniques to become routine affairs. This, in turn, has led to huge advances in drug discovery and in the chemical, biochemical and physical analysis of drugs and patients.
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Scaling Manufacturing Processes Using Single-Use TechnologiesAlthough new single-use technologies offer the flexibility needed to overcome several challenges in ATMP production, there are many considerations and hurdles manufacturers must be aware of when scaling.
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Fixed-Oil Excipient Monographs: Development of USP Fixed-Oil Reference StandardsThis article summarizes the development and modernization of the United States Pharmacopeia-National Formulary (USP-NF) fixed-oil excipient monographs. This article contains bonus online-exclusive material.
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Developing nanoparticle drug carriersNanoparticulate drug carriers include a class of particles made of polymers or lipids that - because of their size and chemical composition -permit systemic and local treatment.
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The Use of Acrylic Resins for Improved Aqueous Enteric CoatingRecent technology improvements have made acrylics the preferred system for the aqueous enteric coating of tablets
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From data to knowledge: the challenge in bioprocess developmentIn biomanufacturing, multiple sensors provide a wealth of data that could be used to enhance process understanding and assist in performance improvement. This article looks at how to move from a data-rich environment to one where the data are translated to useful information that leads to knowledge and, ultimately, process improvements.
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The Squeeze in Contract ManufacturingThe demand for CGMP production of biopharmaceuticals is at an all-time high.
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Cultivating ComplianceThe authors discuss how companies facing ever-evolving regulatory requirements can address and assess compliance risk in their operating practices.
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Cultivating ComplianceThe authors discuss how companies facing ever-evolving regulatory requirements can address and assess compliance risk in their operating practices.
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Controlling the Release of Highly Dosed and Highly Soluble DrugsThe authors formulated bupropion hydrochloride tablets with various grades of methacrylic copolymers and analyzed the properties of the resulting dosage forms. This article is part of PharmTech's supplement "Solid Dosage and Excipients 2010."
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Outsourcing clinical trials: growth continuesThe CRO market is experiencing two-tiered growth: firstly from pharmaceutical companies seeking to lower fixed costs by outsourcing clinical research to CROs; and secondly, from biotechnology and specialty pharmaceutical companies that lack the infrastructure to conduct trials.
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Alcami Grows Contract Manufacturing and Laboratory Business 20% With Waters PartnershipRead a compelling, detailed Case Study about how an innovation partnership with Waters Corporation enhanced Alcami’s capacity, efficiency, and compliance-readiness for their pharmaceutical manufacturing and analytical services to differentiate their offerings and drive business growth.
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How to Engage in a Strategic Outsourcing RelationshipCarefully crafted outsourcing arrangements allow companies to become powerful partners in the quest for market share.
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The extrusion and spheronization of chitosanChitosan is of pharmaceutical interest because of its positive attributes with respect to toxicity, biocompatibility and bioavailability.
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Particle design using fluidized hot melt granulationFluidized hot melt granulation (FHMG) is an emerging technique combining the advantages of both dry and wet granulation methods, and represents an innovative continuous granulation process capable of mixing and agglomerating excipients and active pharmaceutical ingredients (APIs) to produce uniform blends of particles suitable for use in the manufacture of pharmaceutically elegant solid dosage forms.
Latest:
From data to knowledge: the challenge in bioprocess developmentIn biomanufacturing, multiple sensors provide a wealth of data that could be used to enhance process understanding and assist in performance improvement. This article looks at how to move from a data-rich environment to one where the data are translated to useful information that leads to knowledge and, ultimately, process improvements.
