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Content

GMP:STERILE PRODUCTION


GMP:STERILE PRODUCTION



AUTOCLAVES - THE SCIENCE OF STERILIZING

Autoclaves are used primarily to sterilize finished medicines that are sealed in their final containers and media and equipment used in microbiological laboratories, as well as a variety of things used in aseptic manufacture.

This program examines the science involved in achieving sterility and some of the pitfalls that await unwary users of autoclaves.

Content includes: About autoclaves; The science of killing microorganisms; Air and temperature; Porous loads; Laboratory science - Biological indicators.

Complete with full documentation - transcript, glossary of terms, printable multiple choice knowledge test, presentation summary sheets and editable QuestionMaster quiz software.


DVD-ROM / 2010 / () / 22 minutes

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AUTOCLAVES - THE STERILIZATION PROCESS

Autoclaves are used primarily to sterilize finished medicines that are sealed in their final containers and media and equipment used in microbiological laboratories, as well as a variety of things used in aseptic manufacture.

This second program on steam sterilization examines the practice of autoclave use - the working of the whole sterilization process.

Content includes: The sterilization elements; Validation principles; Sterility assurance; Determining loading patterns and cycles; Validation specifics; Re-qualification of autoclave processes.

Complete with full documentation - transcript, glossary of terms, printable multiple choice knowledge test, presentation summary sheets and editable QuestionMaster quiz software.


DVD-ROM / 2010 / () / 24 minutes

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WORKING IN CLEAN AIR

This program details the principles of working in 'clean air'. Content includes: Who needs clean air ?; What is clean air ?; Clean air standards; Clean air workstations; The nature of contamination; People - hygiene & apparel; Working in unidirectional airflow; Monitoring & maintenance; Review.

DVD-ROM / 2010 / () / 35 minutes

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AUDITING STERILE PRODUCTION AREAS

Content includes: Access to Aseptic Manufacturing Areas; General Overview of the Facility; Air Filtration and Pressure Differentials; Requirements for Areas within Aseptic Manufacturing; Equipment for Aseptic Manufacture; Monitoring of Aseptic Areas; Validation; Personnel; Filtration; Testing. Includes interactive FDA and EU GMP regulations.

DVD-ROM / / () / 25 minutes

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CONTAMINANTS & THEIR SOLUTIONS

A fundamental program for all who must control contamination. Contaminants are examined in detail, together with the solutions for their control. Contains instruction on: preventing contamination; non-viable contamination; particle adhesion; chemicals; removing particles; static electricity; viable contamination; controlling microorganisms; disinfectants.

DVD-ROM / / () / 35 minutes

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CONTAMINATION CONTROL IN PRACTICE

Contamination control practices are crucial to the safety and reliability of many products. Working with products sensitive to micro-contamination under clean conditions is a very responsible task. Everybody involved needs to control contaminants that they cannot see and that makes understanding them absolutely essential.

This program is an introduction to the subject illustrating the reasons for, and the controls related to, super-clean production environments.

The subject chapter headings are:
  • Introduction
  • Contaminants
  • Clean air, cleanrooms & associated controlled environments
  • People in cleanrooms
  • Precision cleaning & disinfecting
  • Review


  • DVD-ROM / / () / 25 minutes

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    EQUIPMENT & MATERIAL SELECTION

    Precision cleaning requires that materials and equipment are totally compatible to the task. This module provides the necessary information from which to make such selections. Contains instruction on: how to understand the needs; the criteria of selection; types of vacuum; wipers and their uses; the chemistry of cleaning; selecting cleaning agents and choosing disinfectants.

    DVD-ROM / / () / 34 minutes

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    INTRODUCTION TO LABORATORY SKILLS

    This professional multi-media program is a fully documented competency training course that provides a comprehensive Introduction to Laboratory Skills. Presented in 4 parts plus part-by-part Review section this complete course is designed both for training new personnel and re-training all laboratory staff who are subject to regulatory control. Content includes: Laboratory Integrity, Regulation, Methods & Documentation, Safety & Working Practices, Equipment, Housekeeping and Maintenance.

    DVD-ROM / / () / 16 minutes

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    INTRODUCTION TO STERILE & ASEPTIC PRODUCTION

    A completely new visualization of core sterile learning module with intelligent assessment to promote the performance and quality required in sterile and aseptic environments.

    This program is an introduction to the subject illustrating the reasons for, and the controls related to, sterile and aseptic production. The subject chapter headings are:
  • Introduction
  • The Contaminants
  • Sterile Production
  • Clean Environments
  • Personnel & Sterility
  • Cleaning & Disinfection
  • Preparation & Processing
  • Methods of Sterilization


  • DVD-ROM / / () /

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    PREPARING & GOWNING FOR STERILE PRODUCTION

    Making parenteral [sterile] drugs or medical devices requires the greatest dedication to training. It is essential to follow stringent preparation and gowning protocols before entering a sterile environment.

    This program follows the training of newcomers to sterile production as they learn the background to sterile and aseptic operations and then how to prepare and dress for working in this very special environment. The program includes:

    Part 1: Introduction
    Part 2: Contamination control & cleanrooms
    Part 3: The preparation & gowning protocol
    Part 4: Leaving the cleanroom
    Part 5: Summary


    DVD-ROM / / () / 19 minutes

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