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In the context of GMP, cleaning is as critical a process as any production activity. The need for it to be properly validated is now recognized and addressed by regulatory authorities as a central quality feature of contamination control. This DVD covers the following areas; validation in the context of cleaning; devising the cleaning strategy; residues & residue limits; cleaning validation protocol; surface sampling techniques.
'A self-evident truth is that if you don't get your cleaning right you're in for trouble. So, when auditing vendors, contractors or internally for the quality of cleaning, a lot rests on the auditor's observations...'
Starting with a review of the contaminants to be controlled in cleanrooms, the program illustrates the importance of a precise cleaning specification. It details the procedures to be followed and individual techniques for every aspect of cleaning, as well as showing the common methods of testing for surface cleanliness.
The program identifies why precision cleaning requires careful analysis and details how to compile the SOP to include specifications and post cleaning tests. Topics include: research every activity; priority zoning; how to specify materials & equipment; how to specify procedures; training needs; surface tests in detail.
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.
Introduction
Prevention - The cleanroom
Non-viable contaminants - The theory of particle attraction
'Contamination Control in Practice' is a complete starter course for those who work in cleanrooms or similar unique environments where micro-contamination must be controlled. This video-based program is a consistent and engaging way to educate and assess personnel for reliable production....
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.
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.
Part One illustrates the disciplines created by the use of Standard Operating Procedures [SOPs] and the preparation of staff and materials. Part Two demonstrates the complete cleaning and disinfection process of sterile and aseptic production areas including ceilings, walls, floors and equipment.
The discipline of working in cleanrooms extends to every aspect of personal hygiene and cleanliness which underpins the high standards of working practices needed for effective control of contamination. It explains contamination, its sources, the cosmetic problem, health and personal hazards.
Airflow characteristics have a significant bearing on the effectiveness of cleanroom operations and are influenced not only by the behavior patterns of people, tooling and equipment, but also their interrelationship.
This program visualizes airflow rates and the effects of airflow, illustrates equipment placement, explains the effects of solid and pierced surfaces and materials placement criteria.
Before cleaning starts, staff must prepare themselves, their equipment and materials and understand the do's and don'ts of personal behavior during the cleaning process. It covers staff characteristics and preparation of equipment and materials.
The often hazardous materials used in cleanroom operations and the unnatural clothing and behavior necessary, combine to make it essential that each operator is fully trained in all aspects of safety for working in cleanrooms. Topics are: accidents are avoidable; hazardous materials; cleanroom hazards - fire, explosion, toxic, physical; storage & handling; dealing with emergencies.