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CLEANING IN MEDICAL INDUSTRY

CLEANING AND SURFACE PROCESSING

parts2clean expert forum 2016

Hannes Köble, Sales

OVERVIEW

1. Parts / Requirements

2. Validation and qualification

Machine equipment

Installation site

Documentation

Process

Preparation

© DürrEcoclean GmbH / UCM AG, Cleaning and Surface Processing, p2c expert forum, Cleaning in medical industry, 05/2016 2

PARTS / REQUIREMENTSParts

Implants / dental implants (titanium or stainless steel)

Medical instruments / components / tools

Needles / cannulas


PARTS / REQUIREMENTSCleaning solutions – suitable processes

Sterile productse.g. implants, dental implants,

inhalators,…

Packing

sterile (clean room)

Subsequent cleaning / passivation

Cleaning before sterile packing

Final cleaning / passivation

Primary cleaningCleaning after machining (e.g. drilling,

milling, turning…)

Cleaning after grinding, blasting, polishing

Unsterile productse.g. Instruments, tools, parts for dental

braces,…

Packing

unsterile

Final cleaning / passivation / el. polishing

Cleaning after grinding, blasting, polishing

Primary cleaningCleaning after machining (e.g. drilling,

milling, turning…)


PARTS / REQUIREMENTSMachines

Dürr Ecoclean EcoCCore (left) & Minio 75P (right)


Primary cleaning

Mostly solvent machines

Minio 75P

EcoCCore

EcoCCompact

Sometimes water based

EcoCWave

Cleaning after machining


Multi-stage immersion cleaning systems

Customized

Aqueous

Final cleaning

Cleaning after finishing

UCM multi-stage cleaning system





Multi-stage immersion cleaning systems

Customized

Aqueous

Subsequent cleaning

Cleaning before packing

PARTS / REQUIREMENTSTask and requirements

Cleanliness requirements

General requirements: free from residues and particulate contamination, stain-free

Toxic residues: Cytotoxicity

Aerobic bacteria: Bioburden

Organic residues: (TOC = Total Organic Carbon)

Biological residues: Endotoxin


OVERVIEW

1. Parts / Requirements

2. Validation and qualification

Machine equipment

Installation site

Documentation

Process

Preparation


VALIDATION AND QUALIFICATIONProcess validation in medical technology

Process validation

Process requirements must be specified by manufacturer (or by final customer). Conformity to requirements must be recorded by manufacturer. This means that the whole process chain must be observed.

Machine qualification

Each technical system within the process chain must be qualified, e.g. every single cleaning step

Most important regulations:

GMP (= Good Manufacturing Praxis), Europe

GAMP (= Good Automated Manufacturing Praxis), Software validation.

FDA (= Food and Drug Administration) chapter CFR 21 Part 11 describing among others, the archiving of data and the electronic signature


VALIDATION AND QUALIFICATIONProcess validation in medical technology

Cleaning validation

The technical validation of the cleaning process is not possible by a 100% cleanliness control of the parts. Therefore, the commonly applied process is the documented monitoring combined with random samples.

Sufficient for the documentation of an unchanged cleaning process is:

Detection of relevant process data (e.g. times, temperatures, alarms, etc.) with batch assignment

Storing the data in steady Format (print, PDF)

Recording of the process parameters with calibrated sensors

Control of the results through sampling in appropriate intervals

Recording of all materials with direct contact with the product, including proof of origin (e.g. fixtures)


VALIDATION AND QUALIFICATIONMachine equipment

Process data acquisition

Recording and archiving of process-relevant parameters

Temperature, system pressure, conductivity, pH, process times…

Drying pressure, drying temperature (minimum / maximum)

System alert messages including alert message number(s)

Counter � Software counter necessary (total / good / not good /day counter)

User � Logged operator (access permissions usually differentfrom the standard)

Data storage

Printout

csv-file on defined place in local network

As PDF/A


VALIDATION AND QUALIFICATIONMachine equipment

Barcode scanner

Various configurations possible

1. Batch number and cleaning program number are included in bar code (best case)

2. Only batch number in barcode. Cleaning program number must be determined by allocation table (to avoid)

3. Signal is provided by customer � e.g. Barcode scanner, RFID, mechanically coded Basket


VALIDATION AND QUALIFICATIONInstallation site

Installation within clean room

Single-stage cleaning machines DÜRR

ISO-Class 9 – 7 (after adjustment)

Multi-stage cleaning machines UCM

ISO-Class 9 – 1 (customized)

Or: Discharge into clean room



VALIDATION AND QUALIFICATIONDocumentation

Support for the system qualification

The documents produced at a plant qualification can quickly fill a whole Folder. Lot of paperwork!

A clear agreement which documents have to be created by the manufacturer and which ones have to be created by the customer needs to be agreed, prior to contract award. Only then can a smooth qualification course can be ensured.

The following documents can only be created by the customer:URS, PQ-plan, PQ-report, final report.

All other documents can theoretically be created by both parties. A close coordination during the project is highly recommended.


VALIDATION AND QUALIFICATIONProcess


Planning

PQ

IQOQ

DQ

Approval PQFinal report

Applicability analysis

Approval DQ

Approval IQ

Approval OQ

Quality project plan (QPP)

DQ-plan

Processing DQ

DQ-report

FDS

FMEA

IQ-plan

Processing IQ

IQ-report

OQ-plan

Processing OQ

OQ-report

PQ-plan

Execution PQ

PQ-report

Construction

Construction approval

Manufacturing and IO

FAT-run + report

Transport +

Assembly

SAT-run + report

Customer(QD)

Customer(QD)

+

Supplier

Customer (production)

VALIDATION AND QUALIFICATIONPreparation

Timely clarification saves a lot of rework

Before the contract is awarded, a clear requirements specification sheet must be set. A subsequent or missing specification (URS) leaves a plausibility gap throughout the entire qualification documentation.

The cleaning program from the preliminary tests is usually adopted for the process and can only be subsequently altered with great effort (requalification of the plant). Therefore, if possible, final trials should be run in technology centers on a pilot plant, in which the cleaning program is determined. The analyzes for this purpose can take up to four weeks and should be available at the beginning of the qualification documentation.

In order to professionally estimate the cost of assistance in the qualification documentation, the responsibilities must be clearly defined previously.


VALIDATION AND QUALIFICATIONPost processing

Maintenance of the qualification

Continuous documentation of system alerts and defaults. All deviations are recorded therein and permanently processed.

Periodic calibration of the sensors. Must be defined in a timetable.

Maintenance according to maintenance manual. Must be defined in a timetable.

Monitoring of the bath quality (primarily aqueous systems)


ABBREVIATIONSGlossary

URS User Requirements Specification

QPP Quality Project Plan

DQ Design Qualification

FDS Functional Design Specification

FMEA Risk analyses (Failure Mode and Effects Analysis)

FAT Factory Acceptance Test

IQ Installation Qualification

OQ Operation Qualification

SAT Site Acceptance Test

PQ Process Qualification


CLEANING IN MEDICAL INDUSTRY

Hannes Köble, Sales

parts2clean expert forum 2016

www.durr-ecoclean.com | www.ucm-ag.com

CLEANING AND SURFACE PROCESSING

Hannes Köble, Sales - Deutsche Messe AGfiles.messe.de/abstracts/68180_UCM_AG_Cleaning_in... ·...

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