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Supplier: Heinkel USA
Description: increasingly being used for biotechnological and pharmaceutical filtration and drying tasks in aseptic environments. Steam sterilizable filter dryers allow for full validated sterility during the filtration and drying process in production lines for API's, intermediates and fine
- Application / Industry Use: Sanitary / Pharmaceutical, Other
- Pressure Filtration Equipment: All Pressure Filters, Other
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Supplier: NETZSCH Premier Technologies LLC
Description: DeltaVita® Grinding and Dispersing of Pharmaceuticals General The comminution or deagglomeration of active pharmaceutical ingredients (API) is called micronization and brings about several advantages. The increase of the particle surface caused by
- Equipment Types: Ball / Media Mill
- Feed: Batch
- Industry or Material Processed: Pharmaceutical / Cosmetics
- Process Type: Wet
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Supplier: ASTM International
Description: 1.1 This guide applies the life-cycle approach to cleaning process validation, which includes the development, qualification, and verification of cleaning processes. It is applicable to pharmaceuticals (including active pharmaceutical ingredients (APIs)); all dosage forms; over
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Supplier: ASTM International
Description: procedures in this standard practice for calculating safe limits of chemical residues are based on Guide E3219. 1.3 This practice applies to pharmaceuticals (including active pharmaceutical ingredients (APIs); dosage forms; and over-the-counter, veterinary, biologics, and clinical
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high resistance of repeated steam sterilization and hot water disinfection. Key Features High Chemical Resistance: Suitable for aggressive solvents and acids, ideal for chemical and biopharmaceutical processes. Sterilization Capability (read more)
Browse Filter Elements Datasheets for Harbory Filtration -
withstand a wide range of process media, potent active pharmaceutical ingredients (API's) and aggressive cleaning regimes used to clean pipework and vessels. PPE material grades are Federal Drug Administration FDA and United States Pharmacopeia (read more)
Browse O-rings Datasheets for Precision Polymer Engineering Ltd.
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Tech Transfer: Don't Fumble the Hand Off
By Angelo De Palma, Ph.D., Contributing Editor BMS evaluates each product and process individually, weighing the benefits against the investment in PAT infrastructure, training and implementation. Safety is a major benefit. If a PAT sensor reduces exposure to a toxic or potent API to zero, it s
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Quality Systems Dominate at Interphex Dalian
By Michele Vaccarello, Digital Managing Editor Reed Sinopharma recently hosted the 60th Annual API China event which paired with INTERPHEX China this May in the World Expo Square of coastal city, Dalian, China. The three-day conference hosted some 35,000 visitors and 400 exhibitors. Its theme
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Regulatory approval and a first‐in‐human phase I clinical trial of a monoclonal antibody produced in transgenic tobacco plants
The bulk API was sterilized by filtration and aliquotted into sterile containers by McEwen Laboratories Ltd, Pangbourne, UK.
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State‐of‐the‐art process for the safe synthesis of anticancer drugs
Most APIs undergo a sterilization process during fill-finish opera- tions, so very few APIs are produced as sterile products; however, it is desirable to conduct final processing in an environment appropriately free of particulate material such that foreign particles are not…
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Sterilizing Filtration for Production of Strontium-82 Active Pharmaceutical Ingredient
Sterility testing of Sr-82 API obtained from this steriliz- ing filtration technology was performed at the Russian Sci- entific Center for Radiology and Surgical Technologies (RSC RST), Russian Ministry of Health.
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Microbial Corrosion in Linepipe Steel Under the Influence of a Sulfate-Reducing Consortium Isolated from an Oil Field
Fig. 3 FESEM and EDS analysis on the API X52 exposed to sterilized BaarÕs medium .
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Alternative methods of terminal sterilization for biologically active macromolecules.
…technological advances in the area of protein and peptide sterilization, which has largely come from the food industry and has in recent years been developed for pharmaceutical use, techniques have been developed for the terminal sterilization of thermally sensitive APIs and biopolymers.
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Pharmaceutical Suspensions
In addition, if a sterile formulation will be developed, the effect of typical sterilization methods on the API should be evaluated (dry heat sterilization, autoclaving, ethylene oxide treatment, gamma irradiation).
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The hydrogen permeation investigation of API X56 steel in sea mud
Compared with the hydrogen permeation current density of API X56 steel in the sterilized sea mud, the hydrogen permeation of API X56 steel in the sea mud could be accelerated by living SRB.
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Isolation of endophytic diazotroph Pantoea agglomerans and nondiazotroph Enterobacter asburiae from sweetpotato stem in Japan
P. agglomerans and E. asburiae based on the identification of the isolates from surface- sterilized stem samples using the API 20E diagnostic kit and 16S rRNA gene sequence analysis.
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Assessment of Performance of Manufacturing Procedures in a Unit for Production of Investigational Anticancer Agents, Using a Mixed Effects Analysis
…both in number of units per batch as well as in number of batches); flexibility (due to relatively many changes in strength and/ or composition of batches); aseptical manufacturing process as the instability of the APIs often does not allow heat sterilization .
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Bookshelf and Unified Agenda > Department of Health & Human Services > Food and Drug Administration > Guidance Documents > ICH Guidelines > Quality > [FDBKF200...
The sterilization and aseptic processing of sterile APIs are not covered by this guidance, but should be performed in accordance with GMP guidelines for drug (medicinal) products as defined by local authorities.