Honeyman Group

The Cleanrooms: Principles in Practice Course provides a holistic view of the design, operation and management of cleanrooms and is suitable for all personnel who work in or manage a clean room environment. As leading consultants in sterile process manufacturing, terminal sterilisation and aseptic production, the Honeyman Group have a wealth of experience in the design, build, validation and ongoing monitoring of cleanrooms. Working with many of the world’s leading pharmaceutical and medical device manufacturers, the Honeyman Group are currently involved with a number of cleanroom design projects encompassing feasibility studies, design and build specifications and risk assessments. The Honeyman Group’s Analytical Services Laboratory works with a number of clients to evaluate, advise upon and develop ongoing environmental monitoring, cleaning validation and disinfectant efficacy programmes.

Successful cleanroom design and management requires an understanding of the regulatory expectations for the processes conducted, how the design is demonstrated to work as intended and continues to do so while accommodating the rigours of day to day use. This three day course delivers a comprehensive overview of the regulatory and design requirements of the cleanroom facility, highlights the interaction between materials and personnel within the cleanroom, examines the principles of HVAC design, filters and air filtration and provides guidelines for ongoing contamination control through environmental monitoring and cleaning.

The course has been developed by industry experts in cleanroom design, cleanroom validation, microbiology and quality assurance. The most effective way of understanding clean room operations is to be involved in hands on exercises, demonstrations and workshops, therefore this course will be reinforced by all three practical sessions.

Location	Date	Fee	Book Course
Barnard Castle, UK	2014 Dates TBA	TBA

Course Content

Day 1

Introduction

History of development towards cleanroom processing in the pharmaceutical industry.

Cleanroom Design

Cleanrooms are confronted with challenges to maintaining suitable conditions from the external and its own internal environment.Weather, seasons, traffic ensures constantly changing challenges to the clean environment as well as the influence of the nature of the process and the technology used.The key aspects that differentiate a cleanroom from other processing areas will be discussed to ensure that once built a cleanroom will meet the needs of the process as will options available to meet current typical processes.

·HVAC Design

Air supply is the most crucial feature in any cleanroom. Its delivery will vary according to the configuration of the cleanrooms and the nature of the processes conducted within them. The provision of an "off the shelf" is likely to be exception in a cleanroom design. The typical components of HVAC systems will be discussed and their influence on the quality of the air supplied. In particular the principles of filtration will be discussed with an emphasis on the HEPA filters used in the higher grade cleanrooms.

·Basic Microbiology

Some basic microbiological knowledge for non microbiologists. This information will not only be of use in understanding what is happening in your own facilities but help prepare you for the planned practical sessions that are to follow.

·Microbiology Practical Sessions

These practical sessions will highlight the challenges personnel and the environment present in microbiologically contaminating your processes and reinforce the need for microbiological control in cleanrooms.

Day 2

·Design Qualification

Design qualification (or review) of a cleanroom is an important step in ensuring right first time production. It not only provides a sanity check on your design to ensure operability and compliance needs are met but will help prepare your quality system for its introduction into use. This will be an example based session where all will be able to participate in a DQ process, helping you prepare for similar exercises within your own facilities.

·Validation

This session will discuss the specific testing involved in determining that the cleanroom and to some extent the processes within work as intended. Many companies will use specialist contractors to conduct much of this testing who will supply the test equipment. Even in these circumstances it is important that an organisation understands the basis of the tests and what the results are telling them as the data will be regarded as their responsibility. The information provided will help prepare you for the practical sessions that are to follow.

Non viable Particle Counting

Particle loading in a clean environment is its most key characteristic and indicator of its quality. Any cleanroom operator should therefore have the use of at least one particle counter. This session will discuss the principles of compliance and its relevance in maintaining compliance in the pharmaceutical industry. Information provided will help prepare for the practical session to follow.

·Non viable/Physical Practical Sessions

Demonstration of the key validation and monitoring tests conducted within a cleanroom environment.

Day 3

·Monitoring and Maintenance

Routine physical, non viable and viable monitoring will be required to ensure the environment is in compliance. Typical monitoring techniques will be discussed together with devising sampling plans and conducting effective trend evaluation. An example based session will be conducted to evaluate the risks to the environment and devise an effective monitoring programme. This will give the knowledge for similar exercises in your own facilities. Ensuring consistency in operation is important in the validity of any validation and monitoring data gathered. The role of an effective maintenance and calibration programme will be discussed.

·Cleaning and Disinfection

However effectively designed and built, any cleanroom will require a routine cleaning programme with use. Cleaning methods and equipment will be discussed and their potential to compromise the facilities where they are used. Choice and use of disinfectants will influence the control of microbial contamination within the cleanroom. Types of disinfectants available and their appropriate application relative to the nature of cleanroom use will be discussed.

·Personnel

Manning levels and activity have a major influence on successful achievement cleanroom standards particularly in relation to microbiological compliance. Appropriate hygiene standard and behaviour for cleanroom staff will be discussed as well as getting the message over.

·Regulatory

Meeting regulatory compliance is key to maintaining business confidence and ensuring patient safety. Regulatory expectations regarding cleanroom manufacture in the EU & USA will be discussed. Biotechnology has a growing importance pharmaceutical manufacture and many of its processes are conducted in cleanrooms. Cleanroom standards in use for the technologies will be discussed.

·Microbiological Assessment Practical Sessions

Microbiological cultures will be examined and the implication for the manufacturing environment discussed.

Who Should Attend

Who Should Attend?

This course is suitable for all personnel involved in the operation and management of cleanrooms including Engineers, QA, Validation and Operations Personnel.

Course Objectives

Key learning objectives of the course are:-

To increase knowledge of fundamental principles for all personnel involved in the management and operation of clean rooms.
To enable delegates to apply knowledge gained to participate in risk assessments and investigations in their own facility.
To provide the background on how GMP regulations and ISO Standards define Cleanroom Design, Operation and Validation
To understand the sources of microbiological contamination and how to control and minimize them within the clean room.
To understand current best practices for gowning, changing and operator qualification
To understand the features of clean room facility design and how the type of product and operations influence the design.
To understand the qualification of HVAC systems and how to interpret data
Understand key tests involved in clean room qualification, smoke testing, particle counting
Understand how to use impact assessment to define system boundaries and identify critical components
Present a cost effective approach to validation of clean rooms
Cleaning and maintaining control within the clean room

Dates & Costs

Dates and Costs

Please see the table above for the dates of next courses and the costs.

Please note: Our online booking system works in £GBP. The € Euro price is a guide price only. The final € Euro amount payable online will be the current exchange rate of the £GBP amount.

If you wish to raise a purchase order or pay via any other means than Credit Card for a booking then these € Euro guide prices will prevail as being the booking cost despite any fluctuation in exchange rates.

Honeyman reserves the right to amend any prices at any time. All advertised prices are exclusive of any applicable VAT or local taxes.

Terms and Conditions

Terms and Conditions

Cancellations received and confirmed by Honeyman will incur a 50% fee up until 31 working days before the start date of the course. No refund will be made for cancellations within 30 working days of the course start date and the full course fee will be due for delegates who fail to attend, (even if the course fee has yet to be received).

Substitutions may be made at any time up to the start of the course, free of charge.

Delegates completing the optional Teesside University Accreditation will incur a 50% cancellation (received in writing and confirmed by Honeyman) fee up until 31 working days before the start date of the course, after which the full course fee will be due.

Cheques and Bank Transfers are to be cashed prior to booking confirmation.

We reserve the right to charge an administration fee to delegates who wish to have their place transferred to another course.

Reservations not confirmed by payment by the course start date will be allocated to any persons on a waiting list.

We reserve the right to change the programme, speakers, date or venue without notice, or to cancel an event.

In the unlikely event of cancellation occurring, delegates will be notified as soon as possible and will receive a full refund of fees paid.

Honeyman is not responsible for transportation, accommodation or other costs incurred.

A full list of all Honeyman Groups terms and conditions of sale is available on request