BETCO Consulting

Description: The majority of contamination in a pharmaceutical facility, presuming that the air handling system is functioning as designed, that water systems are low in bioburden and are not leaking, and there is good control of in-coming materials, will derive from people. It follows that an effective contamination control strategy will focus on the control of operators. Control extends to behaviors, gowning and having the correct equipment, and this will be supported by periodic qualifications and underpinned by audits.

These requirements are spelt out in EU GMP Annex1, which states1: “The manufacture of sterile products is subject to special requirements in order to minimize risks of microbiological contamination, and of particulate and pyrogen contamination. Much depends on the skill, training and attitudes of the personnel involved. Cleanrooms are restricted areas and admission should be by authorized & trained personnel only. Regulators take a keen interest in all aspects of cleanroom operations, particularly in the pharmaceutical industry. One of the acceptable ways of deciding on a person's suitability for work in a cleanroom is to consider the training they have received and the outcome of that training. 

Learning Outcomes: 

At the end of the program, all participants will:

• Acquire and apply the basic concepts of GMP.
• Recognize the importance of GMP compliance.
• Be familiar with cleanroom behavior and operation requirements
• Understand personnel hygiene and assure its implementation by everyone and at all times
• Be famialr with basic elements of microbiology.
• Be familiar with the serious effect of cleanroom contamination to the product quality and consequently to the patients. 
• Apply all what TO DO and what NOT TO DO in cleanrooms. 
• Be aware about Good Cleanroom Operation Practices.
• Gain knowledge with respect to microbial contamination risks and the role that they play in increasing or decreasing these risks is also of importance.
  
  

Target Audience: All personnel including those performing cleaning, maintenance, monitoring and anyone and everyone who works in a cleanroom needs to be trained to a greater or lesser degree. This is because the entry of engineers, service or quality assurance technicians and janitorial staff can seriously compromise the quality of the air and the level of cleanliness. There must be a basic level of awareness training so that all who enter a cleanroom are conscious of the effect they will have on that environment. So anyone who might possibly need to enter a cleanroom for whatever purpose and for however short a time should undergo some level of training. Cleanrooms operators will require the highest level of training.

 Methodology
 PowerPoint Presentation