Cleanroom Certification Duration

tebusse

Involved In Discussions
#1
Hi everyone,

The medical device company for which I work recently moved into a facility that had an established cleanroom. The cleanrooms were annually certified by a 3rd party to meet ISO 6, ISO 7, and ISO 8 standards. Currently, my company only requires the EM to meet ISO 8.

Since the cleanroom has been certified within the past year, do we have to re-qualify the cleanroom if we are able to produce a copy of the certificate?

I'm currently working on creating the environmental monitoring procedure and associated forms, so I'm also wondering about the number of points/areas within one room must the sampling take place (I believe this is based on square footage).

If it helps, we are only sampling non-viable airborne particles and pressure differentials.

Any assistance would be most helpful.

Tonia
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
C Cleanroom - 209E to ISO14644 Other Medical Device Related Standards 2
P Surgical masks ( type IIR) - Cleanroom Requirements EU Medical Device Regulations 3
J Need for a cleanroom in the manufacture of a medical device for a clinical trial EU Medical Device Regulations 4
D Cleanroom Cleaning Products and Storage Other Medical Device and Orthopedic Related Topics 18
chris1price Cleanroom Monitoring Plan - ISO14644-2:2015 - Risk Assessment Other Medical Device Related Standards 3
C Looking for source of silicone contamination in ISO Class 8 Cleanroom Other Medical Device Related Standards 2
I Cleanroom Actions in case of Actions Limit Alarm Qualification and Validation (including 21 CFR Part 11) 3
W How to bring Cardstock into Cleanroom Environments Manufacturing and Related Processes 1
S Looking for ISO Class 8 Cleanroom Cleaning Procedure example ISO 13485:2016 - Medical Device Quality Management Systems 1
D Use of hand cream inside gloves in the cleanroom for medical devices Occupational Health & Safety Management Standards 7
T Converting an ISO Class 8 Cleanroom to ISO 7 Various Other Specifications, Standards, and related Requirements 4
jkuil Cleanroom Equipment and Furniture Engineering Standards Other Medical Device Related Standards 2
E ISO Class 8 Cleanroom Qualification Protocol Template Other Medical Device and Orthopedic Related Topics 5
B Cleanroom Control Limits: Cumulative or individual? Statistical Analysis Tools, Techniques and SPC 11
I FDA Cleanroom requirements for class II in vitro medical devices US Food and Drug Administration (FDA) 1
C Cleanroom Disaster Recovery for ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 8
A Guidance for Cleanroom Qualification and Validation relevant for EU and USA ISO 13485:2016 - Medical Device Quality Management Systems 2
E Is Volumetric Air Sampling required for Class ISO 7 Cleanroom ? ISO 13485:2016 - Medical Device Quality Management Systems 1
B How to set Cleanroom Alert and Action Limits as part of Microbiological Evaluation Quality Assurance and Compliance Software Tools and Solutions 8
C What is an acceptable bioburden level or count when working in cleanroom ISO class7 ISO 13485:2016 - Medical Device Quality Management Systems 1
W ISO 14644 Cleanroom Validation - "Operational" Other Medical Device Related Standards 3
E A sink with water in an ISO Class 7 Cleanroom ISO 13485:2016 - Medical Device Quality Management Systems 4
W Thoughts on having Safety Shower in ISO Class 7 Cleanroom ISO 13485:2016 - Medical Device Quality Management Systems 5
C Cost Factors of Iso 8 vs. ISO 8/9 Cleanroom Other Medical Device and Orthopedic Related Topics 2
W Cleanroom Cleaning Agents for cleaning a Class 7 Cleanroom Other Medical Device and Orthopedic Related Topics 9
V Making Solar cells, Module, String - Which Cleanroom Level? Various Other Specifications, Standards, and related Requirements 2
H What is the ISO Class 7 cleanroom requirement on Temperature and Humidity ? Manufacturing and Related Processes 3
J Do I need a Cleanroom to manufacture Medical Devices? ISO 13485:2016 - Medical Device Quality Management Systems 4
C ISO 13485 Class 7 Cleanroom Requirements ISO 13485:2016 - Medical Device Quality Management Systems 7
J Yearly Cleanroom Revalidation Test Requirements - Questions for users clean room ISO7 Qualification and Validation (including 21 CFR Part 11) 5
J ISO 14644 - Monitoring Clean Room Particulates (Class 8 Cleanroom) Other ISO and International Standards and European Regulations 4
D Cleanroom Housekeeping and Personnel Hygiene Audit Checklist Other Medical Device Related Standards 25
C Cleanroom Class 8 (100,000) Particulate Control and Warning Limits Statistical Analysis Tools, Techniques and SPC 1
N Dehumidified (Dry) Cleanroom - Running a Cleanroom at very low RH Manufacturing and Related Processes 23
somashekar Use of Pencil in Class 1000 Cleanroom ISO 13485:2016 - Medical Device Quality Management Systems 12
S Cost Surrounding Cleanroom Construction Manufacturing and Related Processes 4
M Cleanroom Qualification and Standard Cleanroom Audit Checklist Process Audits and Layered Process Audits 6
C Pest Control - FDA approved list of Pesticides to use for Pest Pontrol in a Cleanroom Other Medical Device and Orthopedic Related Topics 10
B Checklist for Housekeeping and Cleaning of Class 10k Cleanroom? Other Medical Device and Orthopedic Related Topics 17
R Cleaning Procedure for a Cleanroom Class 7 & 8 ISO 13485:2016 - Medical Device Quality Management Systems 2
L Cleanroom Requirements for Nuclear Components Assembly Design and Development of Products and Processes 4
L Validation of transfer materials - Bioburden of items from lab into cleanroom Other Medical Device and Orthopedic Related Topics 2
A Cleanroom class in semiconductor Other ISO and International Standards and European Regulations 8
A Particle Counter Results - Interpreting Data for a Class 100,000 Cleanroom Other Medical Device Related Standards 12
H Cleanroom vs. Clean hood - MIL-PRF-38534, Class K (space level) for hybrids Manufacturing and Related Processes 3
H Cleanroom Class for hybrids Manufacturing and Related Processes 6
M Cleanroom Gowning Disposable Lab Coats - Class 8 Cleanroom ISO 13485:2016 - Medical Device Quality Management Systems 4
Ajit Basrur Does anyone have a Cleanroom audit checklist? ISO 13485:2016 - Medical Device Quality Management Systems 12
A Class 8 100,00 Cleanroom - Airborne Microbial Count ISO 13485:2016 - Medical Device Quality Management Systems 6
Jen Kirley Cleanroom Standard for Semiconductor Fabrication Wanted Various Other Specifications, Standards, and related Requirements 3

Similar threads

Top Bottom