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Last update:2012.04.04.
 Regulatory Basis  Forum Issues  Intelligence Services  Web Applications  21 CFR Part 11 Compliant Products 

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Documents
Products



Documents

  • The Measurement of Surface Tension Utilizing Quartz Crystal Microbalance and Its Effect on Moisture Evaporation and Film Formation during Aqueous Film Coating of Tablets
    8th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology; 19th to 22nd March 2012, Istanbul, Turkey
    PDF PDF file (772 KB)

  • Thermal Gradient & Humidity Gradient Studies of Water Vapor Sorption of Hydrogel Polymers Used in Drug Delivery Applications with Quartz Crystal Microbalance Vapor Phase Analyzer
    8th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology; 19th to 22nd March 2012, Istanbul, Turkey
    PDF PDF file (748 KB)

  • Exploring a Virtual Tablet Based Approach to Computation of Coating Quality Markers
    2011 AAPS Annual Meeting and Exposition; Washington, D.C., USA; October 23-27, 2011
    PDF PDF file (839 KB)

  • PyroButton
    Wireless mapping, validation, & monitoring of temperature & humidity.
    PDF PDF file (1 MB)

  • PyroButton-SQL-T
    Transportation Temperature Monitoring & Cold Chain Management.
    PDF PDF file (1 MB)

  • PyroButton-SQL-V
    Validation Management of Temperature and Temperature/Humidity.
    PDF PDF file (1 MB)

  • PyroButton-SQL/S
    Sterilization Process Management.
    PDF PDF file (1 MB)

  • HygroQuant Jr.
    High Precision & Cost Effective Measurement of Water Activity.
    PDF PDF file (174 KB)

  • Lab-In-Palm-System
    Rapid determination of endotoxin, -glucan, and peptidoglycan can be performed with high sensitivity.
    PDF PDF file (104 KB)

  • Opulus Reader Calibrator
    Opulus Reader Calibrator ("ORC") is a Unique Product, that Integrates Temperature & Photometric Calibration with Reader Qualification into a Single Unit.
    PDF PDF file (341 KB)

  • Container/Closure Moisture Permeability Study
    The USP test provided for the determination of moisture permeability of containers requires 14 days. Opulus has developed an elegant and effective method, that requires half the time. In addition to the final results various inter-related parameters can be calculated for better understanding of the process and can assist in formulation development.
    PDF PDF file (1 MB)

  • PyroTherm
    PyroTherm is a Computer Integrated High Performance Programmable Heating Instrument.
    PDF PDF file (863 KB)

  • PyroGel HTG
    Increase Your Throughput, Enhance Your Quality, and Improve Compliance. PyroGel Supports IQ-OQ-PQ, OOS, CAPA, and the Evaluation of Your Gel-Clot Test Procedure.
    PDF PDF file (115 KB)

  • PyroGel XT
    Computer Aided Gel-Clot Testing with extended functionality for microplate incubation.
    PDF PDF file (1 MB)

  • PyroSolution - Endotoxin Information Management System
    PyroSolution is the first total solution product in endotoxin contamination measurement, control, and tracking, which provides Total Compliance & Quality Management (TQM) for the users.
    PDF PDF file (207 KB)

  • PyroDoQ
    PyroDoQ is a Unique Product for the Design Qualification of LAL-endotoxin Test System. Can You/Should You Use the Power Curve?
    PDF PDF file (365 KB)


    Products

  • Data-loggers
    We offer the smallest (17mm x 6mm), most accurate, having the best reproducibility, and cost effective calibrated data-loggers.

  • Adapters for multiple data-loggers
    Complete line of reader stations for 8, 16, 32, or 50 PyroButton data-loggers for program upload and data download. Suitable for users having large number of PyroButtons.

  • Calibrators
    PyroButton line of calibrators have been designed with computer integrated modeling and simulation for optimum performance, reduced gradient, high throughput, and full automation for unattended operation.

  • Calibration
    The data-loggers need to be calibrated (or recalibrated) from time to time, according to the effective regulations. Our company calibrates the data-loggers to NIST Standard, according to your request.

  • Facilities
    Various levels of solution products based on PyroButton Self-powered data-loggers, communication systems, and integrated software to meet the requirement for Temperature and Humidity Mapping of the Facilities, Validation of the Storage Conditions, Temperature & Humidity Tracking of Products, Permeability Studies of Containers/Closures, Challenge Studies of Containers/Closures, Maintenance, Qualification & Re-Qualification of Facilities relative to temperature/humidity requirements.

  • Transportation
    Various levels of solution products based on PyroButton Self-powered data-loggers, communication systems, and integrated software to meet the requirement for Temperature and/or Temperature/Humidity Mapping of compartments, Validation of the Storage Conditions, Temperature & Humidity Tracking of Products, Permeability Studies of Containers/Closures, Challenge Studies of Containers/Closures, Maintenance, Qualification & Re-Qualification of transportation logistics relative to Temperature/Humidity requirements.

  • Validation - Temperature & Humidity Validation
    Various levels of validation solution products based on PyroButton Self-powered data-loggers, communication systems, and integrated software to meet the requirement for the Temperature and/or Temperature/Humidity Validation, Validation Maintenance, Qualification, & Re-Qualification of incubators, refrigerators, freezers, warehouses, processing, & quality control facilities.

  • Sterilization - Sterilization Process Management
    Various levels of solution products based on PyroButton Self-powered data-loggers, communication systems, and integrated software to meet the requirement for Sterilization Process Validation, routine sterilization, maintenance, qualification, & re-qualification.

  • Stability
    Various levels of solution products based on PyroButton Self-powered data-loggers, communication systems, and integrated software to meet the requirement for Temperature and Humidity Mapping of the Stability Chambers, Validation of the Storage Conditions, Temperature & Humidity Tracking of Products, Permeability Studies of Containers/Closures, Challenge Studies of Containers/Closures, Calibration of Stability Chambers, Maintenance, Qualification & Re-Qualification of Stability Chambers.

  • Hygroscopicity
    The relationship of hygroscopicity and humidity control is essential in the quality outcome of products. This requirement is especially important in FDA regulated industries, such as pharmaceutical, biotechnology, medical device, and food.



    21 CFR Part 11 Issues
    Various aspects of electronic records and electronic signatures
    Forum Database
    Almost 100,000 searchable messages from 16 working newsgroups. Updated regularly.
    Warning Letters Knowledge Base
    An extremely versatile database that will assist familiarization with the regulatory requirements
    Competency Trainings & Exams
    Multimedia enriched learning materials, exercises and exams.
    On-line Trainings & Exams
    Web-based learning materials, exercises and exams

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