Contamination Control
Im Auftrag der ECA Academy

28-30 November 2018

Berlin, Germany

Seminar Nr. 16425

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Kosten

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Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

Werner Hofstetter, Octapharma, Austria

Arjan Langen, MSD, The Netherlands

Carsten Moschner, dastex, Germany

Dr Inga Marie Schlägl, Bayer, Germany

Axel Schroeder, Concept Heidelberg, Germany

Robert Schwarz, FH Campus Vienna, Austria

Zielsetzung

In most cases the implementation of appropriate hygiene programmes and measures have been implemented as an essential part for the manufacturing of pharmaceutical products. A series of regulations address the subject of microbiological facility control.

The overall goal of such a system is to prevent microbiological contamination of the pharmaceutical product. But even if such a system has been established, it is of utmost importance that these programmes and measures are understood and followed by all operators who carry out quality-relevant work. Therefore, regulations demand intensive training in hygiene issues.

Against the background of these requirements, this ECA education course is designed to cover all important aspects of controlling microbiological contamination. It ranges from sources of contamination to microbiological validation of processes and training of operators. A focus will be on those problems that occur frequently in pharmaceutical production; possible solutions to these challenges will be discussed.

Furthermore, this education course clarifies uncertainties concerning microbiological facility control and provides helpful suggestions for compliance with regulatory demands. Experienced specialists share their expert knowledge with the participants.

Hintergrund

The lack of control of microbiological contamination is an outstanding integral part of inspection findings.

The lack of control of microbiological contamination is an outstanding integral part of inspection findings.

Between 1995 and 2005, the potential risk of microbiological contamination was the No 2 Critical GMP Deficiency and the No 1 Major GMP Deficiency observed during inspections requested by the CHMP/CVMP of EMEA.

MHRA’s review of the deficiencies 2011/2012 issued 57 deficiencies related to personnel as well as 75 contaminations by chemical/physical and microbial causes.

Increasing number of FDA warning letter to sterile manufacturers in 2014:
Total Number 2013 – 16 WL
After six month 2014 – 19 WL

This actual state clearly demonstrates the importance to concern oneself with this topic in detail.

In pharmaceutical manufacture, cleaning and disinfection measures are important and decisive process steps for fulfilling the quality requirements on the medicinal product. To carry them out properly, personnel needs to be both qualified and motivated.
All national and international pharmaceutical GMP regulations — especially those on sterile manufacturing — call for cleaning and hygiene programmes in the pharmaceutical companies.

Zielgruppe

Persons who are involved in

Microbial monitoring
Implementation of hygiene programmes
Selection and qualification of disinfectants
Handling of microbial deviations
Training of operators for monitoring

Programm

Module 1 Requirements and Background

Basic Principles of Hygiene and Microbiology

Microorganisms
Microbial Growth
Characteristics
Sources
Basic hygienic actions
Cleaning/disinfecting/Sterilization
Way of Contamination

Regulatory Requirements

General regulatory requirements and guidelines
Prevention of contamination and cross contamination
Requirements for validation
ISO standards
Quality Risk Management

Sources of Contamination and Preventive Measures

Sources of contamination throughout the facility
HVAC
Water
Raw materials and packaging components
Personnel and clothing

Microbiological Monitoring

Monitoring of non-sterile processes
Aseptic manufacture: developing a programme, interpreting data, regulatory requirements
Monitoring methods; air, surface, people
A complete programme for a sterile product

Trending of Environmental Monitoring Data

How do you do it?
What do the results really tell you?
How should you react on the results?

Microbiological Control of Water Systems

Water as raw material
Contamination sources within the water system
Technical aspects
Control methods
Microbiological testing of water

Qualification of Disinfectants

Different gassing systems
Guidance documents, standards and regulatory requirements
Basis for qualification

Case Study: Managing Disinfection Programmes

Hygiene programme
Cleanroom concept
Demands on environment, equipment and personnel
Cleaning and disinfection concept

Hygiene of personnel – Cleanroom Behaviour

Contamination from Personnel
Classic Employee Deviance
Gowning procedure
Hand disinfection

Validation of a Decontamination System for Production Equipment, Process Devices and Cleanrooms

Technical requirements & Background
Qualification of a fogging system
Validation of a fogging process

Quality Risk Management

Risk Assessment: Risk Identification, Risk Analysis, Risk Evaluation
Risk Management

Cleanroom Garment, Requirements, Selection and Laundering

Different fabrics and their characteristics like filtration capacity and wearing comfort
Garment systems oriented by the cleanroom class
Requirements on decontamination and laundering
Outsourcing

Effective Training of Operators

Regulatory requirements (EU-GMP, FDA Guidelines, experiences from inspections)
Methods and tools
Measurement and documentation of training success
Practical approaches

Cleanroom consumables - a so called „Cent-Product“ but with consequences

Definition of cleanroom consumable products
The impact during the daily application
How is that reflected in guidelines?

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Contamination ControlIm Auftrag der ECA Academy