Getinge cGMP User manual

GETINGE A.B.

Technical Information Data Sheet

Specification for

Getinge cGMP

Equipment Features

cGMP EQUIPMENT FEATURES

TECHNICAL INFORMATION DATA SHEET

Specification for

Getinge cGMP Equipment Features

 Getinge A.B.

Head Office
P.O. Box 69

S-310 44 Getinge

Sweden

Phone [phone] • Fax [phone]

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The Getinge Group

Disinfection and Sterilization Business

Getinge is a world leading company in the field of medical
technology, specializing in the development and manufacture of
equipment for the HealthCare and Pharmaceutical industries.

With over sixty years of experience, and manufacturing plants in
Sweden, United Kingdom, United States, France and Australia, we
are the World's leading supplier of disinfection and sterilization
equipment, serving customers in more than 100 countries on all 5
continents.

Getinge manufactures a full range of steam and gas sterilizers. We
produce a wide range of "industry standard" models and offer a
custom design and build service for special products and
applications.

Always at the forefront of sterilization technology, we are constantly
developing new features and techniques to satisfy the demands of
our customers and regulatory bodies.

We pride ourselves in our world - class, market leading technology,
employing every aspect of our exhaustive experience and 'know­how' to solve our clients' problems in the sterilization of the new
delivery and packaging systems for pharmaceuticals and medical
devices.

© Getinge 1997

Introduction

As the World’s leading manufacturer of sterilization equipment for
the Pharmaceutical Industry, Getinge A.B. accepts a responsibility to
promote the ‘state-of-the-art’ in sterilization technology.

There are few rules and regulations that define ‘cGMP’ in terms of
technical specification. Indeed most sterilizers produced by Getinge
will satisfy those regulations that do exist and in this respect, most
Getinge sterilizers comply with ‘GMP’ requirements.

However, for those customers who require an additional assurance
to be at the ‘leading edge’ in terms of cGMP compliance, Getinge
offers an additional, optional, package of equipment features that
address all current concerns in the industry.

Working from experience gained over many years, we have
developed this set of equipment features designed to satisfy the
known cGMP requirements of the Pharmaceutical Industry ­including those of Europe, U.S. and Japan.

Scope

This document refers specifically to steam sterilizers (Getinge
reference ‘GE’, steam and air mixture sterilizers (Getinge reference
‘GEV’) and circulating water sterilizers (Getinge reference ‘GEC’).

As required, comments are added to distinguish between features
specific to each model.

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© Getinge 1997

Definitions

The 'Product' is defined as the item or items being processed in the
sterilizer.

The 'Process System' is defined as any part of the chamber or
piping system that is in contact with the product, or in contact with
media that is subsequently in contact with the product during a
sterilization process.

Generally, this includes all pipework connected to the sterilizing
chamber, up to and including the first isolation valve and all lines
carrying process media (steam, water or filtered air) to the chamber.

'Control sensor' is defined for the purpose of this document as the
sensor that activates the timer for Exposure Period.

'Exposure period' is defined as the holding period after the Control
Sensor has achieved sterilization temperature.

Comments in parentheses [ ] are specifically for customer
consideration.

'Dead-leg' is defined as any pipe or connection in the Process
System in which there is no flow, that is greater than six (6) times
the internal diameter of the pipe.

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© Getinge 1997