Sterilisation Equipment, Characteristics - VALIDATION€¦ · Complete system with Data loggers...

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Sterilisation Equipment, Characteristics - VALIDATION Günter Dotter Thursday, 26 March 2009, Opatija

Transcript of Sterilisation Equipment, Characteristics - VALIDATION€¦ · Complete system with Data loggers...

Page 1: Sterilisation Equipment, Characteristics - VALIDATION€¦ · Complete system with Data loggers Data loggers Temperature Temperature + pressure ... ETO sterilizers (thermal) X Without

Sterilisation Equipment, Characteristics -VALIDATION

Günter DotterThursday, 26 March 2009, Opatija

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Sterilisation Equipment – Characteristics

VALIDATION

Solutions for Cleaning, Disinfection and Sterilization in Healthcare, the Pharmaceutical Industry and Laboratories

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� Regulatory Requirements

� Measuring Equipment

� Premises and conditions

� Application - Sequence

� Summary

Sterilisation Equipment – Characteristics

VALIDATION

OVERVIEW –Main criteria:

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Sterilisation Equipment – Characteristics

VALIDATION

Regulatory Requirements –within the EU

� MDD, (Medical Device Directive) under directive 93/42 /EEC.

� EN 554

� EN ISO 17665 Part 1 + 2

� EN ISO 14937

� Regulations from national institutions, RKI*, Swissme dic,

� Recommendations from professional associations and societies

* Robert Koch Institute, Berlin, Germany

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Sterilisation Equipment – Characteristics

VALIDATION

Regulatory Requirements –EN 554 / EN ISO 17665 Part 1 + 2 and EN ISO 14937

� Requirements according the EN:

Sterilisation of products and devices for the health c are. General requirements of the characteristics of the steril ant agent and of the development, validation and monito ring on a routine basis of a sterilization process for med ical products.

� The method is based on the monitoring of the physica l parameters i.e. (time, temperature and pressure), which are required to produce sterile products.

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Sterilisation Equipment – Characteristics

VALIDATION

Regulatory Requirements –Personal qualification (EN 554)(EN 554)

Only qualified personnel can

be responsible for:

� Installation and preventative maintenance

� Validation and routine monitoring

� Release of sterile products

� I.e. Certified and authorized Validation specialist

� Certified according EN ISO 9001:2000

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Sterilisation Equipment – Characteristics

VALIDATION

Regulatory Requirements -Reference literature

� ISO-10012-1: Quality requirements for Measuring systems

Measuring failure, less than 3-10 times, as the required measuring accuracy

� EN-554 Sterilisation of medical products

Measuring equipment should have 3 times higher measuring accuracy than measured reference point

� EN-285 Sterilisation – Steam sterilization – Large sterilizers

Failure between 0°C and 150°C, should not exceed + 0.25%

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Sterilisation Equipment – Characteristics

VALIDATION

Measuring Equipment –Overview

1. Temperature Reference2. Temperature Standard3. PC + Validation Software4. Chamber connection – validation5. Data Logger + Interface 6. Pressure Standard – Calibration

1 2 3

4 5

6

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Sterilisation Equipment – Characteristics

VALIDATION

Measuring Equipment –Complete System with Thermo elements

� Validator – Data recorder

� Temperature reference

� Temperature standard

� Thermo elements

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Sterilisation Equipment – Characteristics

VALIDATION

Measuring Equipment –Complete system with Thermo elements

� Temperature reference

� Measuring system

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Sterilisation Equipment – Characteristics

VALIDATION

Measuring Equipment –Complete system with Data loggers

Data loggers

� Temperature

� Temperature + pressure

� Interface + PC

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Sterilisation Equipment – Characteristics

VALIDATION

Measuring Equipment –Selection – Data recording sensors

Logger TC’s� Empty Chamber profile X X� Penetration study (hollow tubes) ���� X� ETO sterilizers (thermal) X ����

� Without Validation port X ����

� Online data ���� X� Multiple measuring points X X� Routine control / less measuring points X X� Surface temperatures ���� X� Rapid temperature changes ���� X

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Sterilisation Equipment – Characteristics

VALIDATION

Measuring Equipment –Norm – Test packs

� Bowie Dick – Test pack

� Bowie Dick – Test sheet

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Sterilisation Equipment – Characteristics

VALIDATION

Measuring Equipment –Balance

According EN 285

� Max. weight 25 kg

� Tolerance < + 0.001 kg

� Calibrated

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Sterilisation Equipment – Characteristics

VALIDATION

Measuring Equipment –Documents – Test report

Binder with documents according

EN 554 / EN ISO 17665 Part 1+2

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Sterilisation Equipment – Characteristics

VALIDATION

Premises and conditions –Example: System with thermo elements

Single steps for the qualification of an autoclave:

� Calibration of the thermo elements – determine tolerances and adjust

� Perform necessary test runs

� Evaluation of the calibration – calibration without adjustments

� Documentation and evaluation

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Sterilisation Equipment – Characteristics

VALIDATION

Premises and conditions –Recorder with thermo elements

Influence of the measuring accuracy are:

Measuring system:

� Measuring writer

� Sensors (Thermo elements)

Calibration system:

� Temperature reference

� Temperature standard

� Human errors

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Sterilisation Equipment – Characteristics

VALIDATION

Premises and conditions –Pressure test (EN 554 / EN ISO 17665 Part 1+2 / EN 285)

Testing the steam quality

� Correlation between Temperature and pressure

� Compare measured value with calculated value from the steam pressure scale

Types of sensors and calibration

� Online pressure sensors with fix connection

� Data logger (pressure) data evaluation after process

� Pressure calibration

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Sterilisation Equipment – Characteristics

VALIDATION

Premises and conditions –Failure source - human

� The calibration procedure itself can cause measuring

failures. In case of calibration devices which are n ot

operate fully automatically, the user is responsible t o

control the stability of the measuring standards and a lso

the sensors.

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Sterilisation Equipment – Characteristics

VALIDATION

Premises and conditions –Calibration system: Reference temperature

Main failure: Transfer calibration failure, Influenced by:

�� Thermal transitionThermal transition

�� Temperature distribution within des block / bathTemperature distribution within des block / bath

�� Depth of immersionDepth of immersion

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Sterilisation Equipment – Characteristics

VALIDATION

Premises and conditions –Calibration system: Temperature standard

� All measuring procedures shall be defined on a nationa l or international standard (ISO-120012-1)

� The standard temperature should be therefore calibrate d, by a certified institution. (i.e. DKD Laboratory of calibration for temperature).

� The measured tolerance of the standard temperature should be declared at the calibration certificate.

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Sterilisation Equipment – Characteristics

VALIDATION

Premises and conditions –Responsibilities

Belimed

� Preparation of the validation plan

� Measuring defined values

� Documentation of the performed measurement

Customer

� Release of the validation plan

� Provide media supply according DIN

� Define load of sterile goods

� Release of the validation report

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(IQ(IQ))

(OQ)(OQ)

Sterilisation Equipment – Characteristics

VALIDATION

Premises and conditions –Sequence of the validation procedure

� Installation Qualification (IQ)

� Operational Qualification (OQ)

� Performance Qualification (PQ)

(PQ)(PQ)

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Sterilisation Equipment – Characteristics

VALIDATION

Application - Sequence

1. Warm up & leak test

2. B & D test

3. Calibration & adjustment of process relevant compone nts

4. Empty chamber profile

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Sterilisation Equipment – Characteristics

VALIDATION

Application –Empty chamber profileApplication - Sequence

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Identification:Identification:

�� Handbook� Papers – pressure vessel� Software version PLC/PC� Program parameter

Media supply:Media supply:�� Steam� Air pressure� Cold water� DI / WFI / WBI water

Sterilisation Equipment – Characteristics

VALIDATION

Application - SequenceInstallation Qualification (IQ)

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� Calibration - sterilizer

� Calibration – measuring probes

� Vacuum test (VPR)

� Steam diffusion test (B&D)

� Empty chamber profile

Sterilisation Equipment – Characteristics

VALIDATION

Application - SequenceOperation Qualification (OQ)

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� Customized loading of sterilization batch cards

� Reference loading are measured (electro- thermal) and documented

� Microbiological evaluation

Sterilisation Equipment – Characteristics

VALIDATION

Application - SequencePerformance Qualification (PQ)

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� After – sterilization process

Sterilisation Equipment – Characteristics

VALIDATION

Application - SequenceTest – residual moist

� Before – sterilization process

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Sterilisation Equipment – Characteristics

VALIDATION

Application - SequenceVisual Test – residual moist

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Sterilisation Equipment – Characteristics

VALIDATION

Application - SequenceDocumentation

� Validation report which is clearly arranged and contains all relevant data

� Comprehensive and precise measuring protocols and calculations

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Sterilisation Equipment – Characteristics

VALIDATION

Application - SequenceRelease – Documentation through customer

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Sterilisation Equipment – Characteristics

VALIDATION

Summary –Customer benefit

� Safe sterilization processes (Cleaning, Sterilisation , Packaging)

� High standard and consistent quality of the processe d medical products

� Competence about actual norms and regulations.

� Analysis of the loading structure

� Optimized process procedure within the CSSD

� Transparent costs and potential of costs savings.

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Thank you for your attention

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