Maintenance of Class 9/8 clean room in a medical devices factory

R

Roland Cooke

#21
Make sure your people know why contamination control is important.

"It looks clean to me, and it's gonna get sterilised anyway - what's the big deal?" :rolleyes:

You can certainly get some useful feedback from the electronics guys, (but of course you need to note that the type of micro-organism can be important, and non-viable particulates don't breed...)
 
Elsmar Forum Sponsor

Ajit Basrur

Staff member
Admin
#22
Qualityalways, thank you very much for your comments.
Smoke test - what smoke can be used so that no contamination is introduced? are there any ready made products? how is it done?
are there any standards... ;)

:thanks:
Smoke Test is generally done for Biosafety Cabinets but you could perform this as an investigational test for assessing the correct flow of air.

The smoke test can be done by placing liquid Nitrogen in a polythene beaker and placing near the air flow. Commercially available "smoke sticks" also can be used which contains Titanium Tetrachloride.

Smoke Test is mentioned in AS / NZS 2243.8.2001 Appendix A.
 
V

Vassilis

#30
Gereard,

Refer to this CETA Guide for general tests required for sterile areas. You can refer to the tests which you feel required.
Please qualityalways reattache the document because i have some problems opening it....:notme:
If you dont mind ofcourse!!! :thanx:
 
Thread starter Similar threads Forum Replies Date
E Software maintenance Process Software maintenance Process to IEC 6204? IEC 62304 - Medical Device Software Life Cycle Processes 3
D Preventive Maintenance vs. General Cleaning ISO 13485:2016 - Medical Device Quality Management Systems 2
J Help settle a disagreement: Should external providers of preventive maintenance be on your ASL? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
F Component maintenance qualification - Regulation (EU) No 1321/2014 Article 5 EASA and JAA Aviation Standards and Requirements 6
K Generic preventive maintenance form wanted Document Control Systems, Procedures, Forms and Templates 2
S Quality management system (Well head installation & maintenance) Quality Management System (QMS) Manuals 5
T ISO 17025:2017 requirement 5.7.b. about maintenance the integrity of the management system ISO 17025 related Discussions 1
A Feedback of typical maintenance problems with LMI digital probes Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
S Are there ISO9001:2015 Requirements for Preventive Maintenance? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 36
Q Software SOP - Use and maintenance of an ERP system Software Quality Assurance 6
R Robotic weld cell - maintenance issues - expertise needed Manufacturing and Related Processes 0
J Requirements for Layered Process Audits including Maintenance, Shipping, Receiving IATF 16949 - Automotive Quality Systems Standard 4
D Preventive Maintenance Implementation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
D Preventative Maintenance for Gages, handtools etc Other Medical Device Regulations World-Wide 1
C Determining if Maintenance Contractor is an External Service subject to ISO 9001 Clause 8.4 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 43
C Maintenance of Product Technical Documentation EU Medical Device Regulations 3
R IATF 16949 Clause 8.5.1.6 a) maintenance and repair facilities - Production tooling management and personnel IATF 16949 - Automotive Quality Systems Standard 4
qualprod Best criteria to measure Corrective Action effectiveness - Poor Maintenance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
M Minitab tool to evaluate PM (Preventive Maintenance) process Using Minitab Software 6
B Total Productive Maintenance - Company Transport IATF 16949 - Automotive Quality Systems Standard 2
P Minor Non-Conformance - Maintenance Records Not Fully Completed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
L 21CRF820.70(g)(2) Maintenance Inspection Interval 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
I Tool maintenance and calibration procedure - Calibrating tools/equipment AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
K IATF16949 8.5.1.5 Total Productive Maintenance IATF 16949 - Automotive Quality Systems Standard 9
J FAA Maintenance Requirements - DER Repair to a PMA Part Federal Aviation Administration (FAA) Standards and Requirements 1
K Maintenance requirements for Production Equipment in AS9100D General Auditing Discussions 8
T Part 145 Maintenance Station S/N ESN Character Requirements EASA and JAA Aviation Standards and Requirements 3
M Preventive Maintenance Spreadsheet in Excel Quality Assurance and Compliance Software Tools and Solutions 2
B IATF 16949 Section 8.5.1.5 (Total Productive Maintenance) IATF 16949 - Automotive Quality Systems Standard 19
D Does AS9100 certified OEM need AS9110 if no maintenance is provided? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
N Laboratory Audit Nonconformance - Maintenance of Standards ISO 17025 related Discussions 10
A Technical File Maintenance - Old generation product EU Medical Device Regulations 4
L Seeking help in Basic Maintenance Knowledge Manufacturing and Related Processes 4
M CAPA due to Consumer not following Maintenance Instructions... Nonconformance and Corrective Action 9
S Preparing a Turtle Diagram for Maintenance Department Misc. Quality Assurance and Business Systems Related Topics 2
U Relating maintenance to product quality Manufacturing and Related Processes 5
S ISO 9001 Audit requirement for maintenance department ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
C Service and maintenance in an initial importer facility USA 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M Total Productive Maintenance vs. Lean, Six sigma, Business Process Reengineering, etc Quality Tools, Improvement and Analysis 9
A Electronic Maintenance Records stored in a machine ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A How to create a Maintenance procedure based on TS 16949 Requirements IATF 16949 - Automotive Quality Systems Standard 5
N ISO 9001 Quality Manual for an O&M (Operations and Maintenance) Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
S Predictive Maintenance Format / Example Misc. Quality Assurance and Business Systems Related Topics 4
T Are Customers required to follow a Manufacturers Maintenance Schedule? ISO 13485:2016 - Medical Device Quality Management Systems 3
E Manufacturer Responsibility (vs. User/Customer) for Preventive Maintenance/Repair 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
A Technical Files/Dossier/STED File Maintenance for Notified Body Audiits Other Medical Device Regulations World-Wide 2
C Document Revision for each new Preventative Maintenance Checklist? Document Control Systems, Procedures, Forms and Templates 5
M Where to start Maintenance Function Kaizen Lean in Manufacturing and Service Industries 4
A Assessing a Preventive Maintenance Strategy - Reliability or Maintenance Statistics Reliability Analysis - Predictions, Testing and Standards 2
J Maintenance Man Hour Plan which satisfies EASA Part 145.A.30 (example needed) EASA and JAA Aviation Standards and Requirements 4

Similar threads

Top Bottom