CLEANING IN MEDICAL INDUSTRY

Transcription

1 CLEANING AND SURFACE PROCESSING CLEANING IN MEDICAL INDUSTRY Hannes Köble, Sales parts2clean expert forum

2 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

3 PARTS / REQUIREMENTS Parts Implants / dental implants (titanium or stainless steel) Medical instruments / components / tools Needles / cannulas DürrEcoclean GmbH / UCM AG, Cleaning and Surface Processing, p2c expert forum, Cleaning in medical industry, 05/2016 3

4 PARTS / REQUIREMENTS Cleaning solutions suitable processes Unsterile products e.g. Instruments, tools, parts for dental braces, Primary cleaning Cleaning after machining (e.g. drilling, milling, turning ) Sterile products e.g. implants, dental implants, inhalators, Primary cleaning Cleaning after machining (e.g. drilling, milling, turning ) Final cleaning / passivation / el. polishing Cleaning after grinding, blasting, polishing Final cleaning / passivation Cleaning after grinding, blasting, polishing Subsequent cleaning / passivation Cleaning before sterile packing Packing unsterile Packing sterile (clean room) DürrEcoclean GmbH / UCM AG, Cleaning and Surface Processing, p2c expert forum, Cleaning in medical industry, 05/2016 4

5 PARTS / REQUIREMENTS Machines Primary cleaning Cleaning after machining Mostly solvent machines Minio 75P EcoCCore EcoCCompact Sometimes water based EcoCWave Dürr Ecoclean EcoCCore (left) & Minio 75P (right) DürrEcoclean GmbH / UCM AG, Cleaning and Surface Processing, p2c expert forum, Cleaning in medical industry, 05/2016 5

6 PARTS / REQUIREMENTS Machines Final cleaning Cleaning after finishing Multi-stage immersion cleaning systems Customized Aqueous UCM multi-stage cleaning system DürrEcoclean GmbH / UCM AG, Cleaning and Surface Processing, p2c expert forum, Cleaning in medical industry, 05/2016 6

7 PARTS / REQUIREMENTS Machines Subsequent cleaning Cleaning before packing Multi-stage immersion cleaning systems Customized Aqueous UCM multi-stage cleaning system DürrEcoclean GmbH / UCM AG, Cleaning and Surface Processing, p2c expert forum, Cleaning in medical industry, 05/2016 7

8 PARTS / REQUIREMENTS Task and requirements Cleanliness requirements General requirements: Toxic residues: Aerobic bacteria: Organic residues: Biological residues: free from residues and particulate contamination, stain-free Cytotoxicity Bioburden (TOC = Total Organic Carbon) Endotoxin DürrEcoclean GmbH / UCM AG, Cleaning and Surface Processing, p2c expert forum, Cleaning in medical industry, 05/2016 8

9 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 9

10 VALIDATION AND QUALIFICATION Process 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 DürrEcoclean GmbH / UCM AG, Cleaning and Surface Processing, p2c expert forum, Cleaning in medical industry, 05/

11 VALIDATION AND QUALIFICATION Process 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) DürrEcoclean GmbH / UCM AG, Cleaning and Surface Processing, p2c expert forum, Cleaning in medical industry, 05/

12 VALIDATION AND QUALIFICATION Machine 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 different from the standard) Data storage Printout csv-file on defined place in local network As PDF/A DürrEcoclean GmbH / UCM AG, Cleaning and Surface Processing, p2c expert forum, Cleaning in medical industry, 05/

13 VALIDATION AND QUALIFICATION Machine 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 DürrEcoclean GmbH / UCM AG, Cleaning and Surface Processing, p2c expert forum, Cleaning in medical industry, 05/

14 VALIDATION AND QUALIFICATION Installation 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) UCM multi-stage cleaning system Or: Discharge into clean room DürrEcoclean GmbH / UCM AG, Cleaning and Surface Processing, p2c expert forum, Cleaning in medical industry, 05/

15 VALIDATION AND QUALIFICATION Documentation 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. DürrEcoclean GmbH / UCM AG, Cleaning and Surface Processing, p2c expert forum, Cleaning in medical industry, 05/

16 VALIDATION AND QUALIFICATION Process Planning Applicability analysis Quality project plan (QPP) Customer (QD) DQ IQ OQ Approval DQ Approval IQ Approval OQ DQ-plan Processing DQ DQ-report IQ-plan Processing IQ IQ-report F D S OQ-plan FMEA Processing OQ OQ-report PQ-plan Construction Construction approval Manufacturing and IO FAT-run + report Transport + Assembly SAT-run + report Customer (QD) + Supplier PQ Approval PQ Final report Execution PQ PQ-report Customer (production) DürrEcoclean GmbH / UCM AG, Cleaning and Surface Processing, p2c expert forum, Cleaning in medical industry, 05/

17 VALIDATION AND QUALIFICATION Preparation 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. DürrEcoclean GmbH / UCM AG, Cleaning and Surface Processing, p2c expert forum, Cleaning in medical industry, 05/

18 VALIDATION AND QUALIFICATION Post 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) DürrEcoclean GmbH / UCM AG, Cleaning and Surface Processing, p2c expert forum, Cleaning in medical industry, 05/

19 ABBREVIATIONS Glossary URS QPP DQ FDS FMEA FAT IQ OQ SAT PQ User Requirements Specification Quality Project Plan Design Qualification Functional Design Specification Risk analyses (Failure Mode and Effects Analysis) Factory Acceptance Test Installation Qualification Operation Qualification Site Acceptance Test Process Qualification DürrEcoclean GmbH / UCM AG, Cleaning and Surface Processing, p2c expert forum, Cleaning in medical industry, 05/

20 CLEANING AND SURFACE PROCESSING CLEANING IN MEDICAL INDUSTRY Hannes Köble, Sales parts2clean expert forum