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Good Manufacturing Practice in Cleaning and Sanitation
Course Summary
Cleaning and sanitation of premises and equipment are essential to efforts to prevent contamination of product, and they need to be done in compliance with Good Manufacturing Practice (GMP) regulatory requirements. This module shows why it is so important to do a good job, what to consider before and during each job, and how best to go about the work.
We begin by explaining how product may become contaminated and what can be done to prevent contamination through effective cleaning and sanitation procedures. We set out good practices to keep the factory clean and sanitary, and we describe how to prepare for and carry out cleaning and sanitation of premises. Finally we turn to the vitally important subject of cleaning and sanitising of production equipment.
Purchasing Information
When you have completed your course order, Zenosis will finalise the setup of your course materials and contact you on the email address that you provide in your order. You can expect this process to be completed within one business day (using the UK business calendar) of completing your payment.
It is therefore essential that you use your real email address for your order, or indicate in the purchase notes the email address to be used for the course set-up, and check that any messages from Zenosis or grapl are not lost in your junk or spam folder.
You will have access to the course module(s) for a period of 180 days after your purchase is complete.
Detailed Course Information
Learning Objectives
• Understand why cleaning and sanitation are so very important in preventing contamination of product
• Adopt good practices in preparing for, carrying out, and recording the cleaning and sanitising of premises and equipment
Who will benefit from this course
Everyone who works in a manufacturing environment in the pharma/biotech industry will benefit from this module.
Module Outline
Module overview – An outline of the module’s scope and objectives, and notes on terminology.
Preventing contamination – Preventing contamination of product is one of the highest priorities in the factory, and effective cleaning and sanitation are essential to these efforts. In this session we describe sources of contamination and how to deal with them. We discuss the agents and equipment used, precautions to be observed, and the principles of the work required.
Cleaning and sanitation of premises – The whole factory must be kept clean and sanitary. In this session we discuss how to contribute to general cleanliness of the premises and how to go about cleaning surfaces in the buildings. We also outline pest control measures.
Cleaning and sanitising of equipment – Production equipment must be thoroughly cleaned, and sanitised as necessary, to prevent contamination of product. In this session we describe how to go about this vital task in compliance with GMP requirements. We discuss how the grade of work required may vary according to the use of equipment, and we emphasise that written and validated procedures must be followed exactly. We focus on equipment parts that require particular attention, and we explain the significance of hold and dwell times. We end with the completion of cleaning status tags and records, and we outline the use of automated clean-in-place systems.
Assessment – Multiple-choice mastery assessment.
Roles
Manufacturing personnel
CPD Points
1
Region
Level
Introductory/Intermediate
Course Study Time
Approx 1 hour
USA, Europe, Other